Purpose

This phase II LUNG-MAP treatment trial studies how well combination treatment (talazoparib plus avelumab) works in treating patients with non-squamous non-small cell lung cancer that has an STK11 gene mutation and has come back (recurrent) or is stage IV. Talazoparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Immunotherapy drugs given as single therapies or in combination with chemotherapy do not appear to work as well in lung cancer cells with mutations in the STK11 gene versus those that do not have the mutation. Adding the medicine talazoparib to the immunotherapy drug avelumab may work better in treating lung cancers that have an STK11 gene mutation.

Conditions

Eligibility

Eligible Ages
All ages
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients must be assigned to S1900C. Assignment to S1900C is determined by the LUNGMAP protocol genomic profiling using the FoundationOne assay. Biomarker eligibility for S1900C is based on the identification of a pathogenic somatic mutation in STK11 or STK11 bi-allelic loss on tumor
  • Patients must have histologically or cytologically confirmed stage IV or recurrent non-squamous, mixed squamous/non-squamous (e.g., adeno-squamous carcinoma), or non-small cell lung cancer not otherwise specified (NSCLC NOS). Patients with pure squamous cell carcinoma are not eligible
  • Patients with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy within 28 days prior to sub-study registration
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. Patients with HCV infection who are currently on treatment must have an undetectable HCV viral load within 28 days prior to sub-study registration
  • Patients with known human immunodeficiency virus (HIV) infection are eligible, provided they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test and within 6 months prior to sub-study registration
  • Patients must have received at least one line of anti-PD-1 or anti-PD-L1 therapy for stage III, IV or recurrent disease. Any number of additional, non-platinum-based chemotherapy or targeted therapy regimens for recurrent or metastatic disease are allowed
  • Patients may not have received more than one line of anti-PD-1 or anti-PD-L1 therapy in the Stage IV or recurrent setting. Anti-PD-1 or anti-PD-L1 therapy may have been given alone or in combination with platinum-based chemotherapy, an anti-CTLA4 therapy, or other immune-modulatory therapy. Patients must have experienced disease progression > 42 days following initiation (cycle 1 day 1) of the anti-PD-1 or anti-PD-L1 containing regimen
  • Patients who did not receive anti-PD-1 or anti-PD-L1 therapy in combination with platinum-based chemotherapy, must have also received prior platinum-based chemotherapy and experienced disease progression > 42 days following initiation (cycle 1 day 1) of platinum based chemotherapy
  • Patients who received anti-PD-1 or anti-PD-L1 therapy following concurrent chemoradiation for stage III disease as their only line of anti-PD-1 or anti-PD-L1 therapy, are eligible if they experienced disease progression less than (<) 365 days from the date of initiation of anti-PD-1 or anti-PD-L1 therapy
  • Patients who received prior adjuvant platinum-based therapy post-surgical resection for stage I-III disease (i.e. the patient has not received platinum-based chemotherapy for Stage IV or recurrent disease) must have had disease progression during or after platinum-based chemotherapy that occurred less than (<) 365 days from the last date that the patient received that therapy
  • Patients must be able to swallow capsules whole
  • Patients must not have had prior exposure to any agent with a PARP inhibitor (e.g., veliparib, olaparib, rucaparib, niraparib, talazoparib) as its primary pharmacology
  • Patients must not be taking, nor plan to take while on protocol treatment strong P-glycoprotein (P-gp) inhibitors (e.g. dronedarone, quinidine, ranolazine, itraconazole, ketoconazole), P-gp inducers (rifampin, ritonavir, tipranavir), or strong breast cancer resistance protein (BCRP) inhibitors (e.g. elacridar)
  • Patients must have progressed following their most recent line of therapy
  • Patients must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to sub-study registration. Patients must have recovered (=< grade 1) from any side effects of prior therapy. Patients must not have received any radiation therapy within 14 days prior to sub-study registration
  • Patients must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment while receiving treatment on this study. Concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable
  • Patients must have measurable disease documented by computed tomography (CT) or magnetic resonance imaging (MRI). The CT from a combined positron emission tomography (PET)/CT may be used to document only non-measurable disease unless it is of diagnostic quality. Measurable disease must be assessed within 28 days prior to sub-study registration. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. Non-measurable disease must be assessed within 42 days prior to sub-study registration. All disease must be assessed and documented on the Baseline Tumor Assessment Form. Patients whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to sub-study registration. CT and MRI scans must be submitted for central review via Transfer of Images and Data (TRIAD)
  • Patients must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to sub-study registration. Patient must not have leptomeningeal disease, spinal cord compression or brain metastases unless: (1) metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 14 days following treatment, and prior to sub-study registration, AND (2) patient has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to sub-study registration
  • Patient must not have had a major surgery within 14 days prior to sub-study registration. Patient must have fully recovered from the effects of prior surgery in the opinion of the treating investigator
  • Serum bilirubin =< institutional upper limit of normal (IULN) (within 28 days prior to sub-study registration). For patients with liver metastases, bilirubin must be =< 5 x IULN
  • Either alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =< 2 x IULN within 28 days prior to sub-study registration (if both ALT and AST are done, both must be =< 2 IULN). For patients with liver metastases, either ALT or AST must be =< 5 x IULN (if both ALT and AST are done, both must be =< 5 x IULN)
  • Patients must have a serum creatinine =< the IULN or calculated creatinine clearance >= 50 mL/min using the following Cockcroft-Gault formula. This specimen must have been drawn and processed within 28 days prior to sub-study registration
  • Patients must have Zubrod performance status 0-1 documented within 28 days prior to sub-study registration
  • Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia
  • Pre-study history and physical exam must be obtained within 28 days prior to sub-study registration
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years
  • Absolute neutrophil count (ANC) >= 1,500/mcl (obtained within 28 days prior to sub-study registration). Patients must be transfusion independent (i.e., no blood product transfusions for a period of at least 14 days prior to sub-study registration)
  • Platelet count >= 100,000 mcl (obtained within 28 days prior to sub-study registration). Patients must be transfusion independent (i.e., no blood product transfusions for a period of at least 14 days prior to sub-study registration)
  • Hemoglobin >= 9 g/dL (obtained within 28 days prior to sub-study registration). Patients must be transfusion independent (i.e., no blood product transfusions for a period of at least 14 days prior to sub-study registration)
  • Patients must agree to have blood specimens submitted for circulating tumor DNA (ctDNA)
  • Patients must also be offered participation in banking and in the correlative studies for collection and future use of specimens

Exclusion Criteria

  • Patients must not be pregnant or nursing. Women/men of reproductive potential must have agreed to use an effective contraceptive method. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
  • Patients must not have a history of prior organ transplantation, including allogeneic stem-cell transplantation
  • Patients must not have received systemic treatment with corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 7 days prior to sub-study registration. Inhaled or topical steroids, and adrenal replacement doses =< 10 mg daily prednisone or equivalent are permitted in the absence of active autoimmune disease
  • Patients must not have active autoimmune disease that requires systemic steroids (equivalent of > 10 mg of prednisone) or immunosuppressive agents within 7 days prior to sub-study registration (for example disease-modifying anti-rheumatic drugs). Exceptions include: patients with controlled type 1 diabetes mellitus, controlled hypo- or hyperthyroidism, vitiligo, resolved childhood asthma/atopy, or psoriasis not requiring immunosuppressive therapy
  • Patients must not have any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of talazoparib (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, or active peptic ulcer disease). Patients must not have active small or large intestine inflammation such as Crohn's disease or ulcerative colitis within 12 months prior to sub-study registration
  • Patients must not have known prior or suspected hypersensitivity to monoclonal antibodies (grade >= 3)
  • Patients must not have any history of anaphylaxis or uncontrolled asthma. Uncontrolled asthma is defined as a patient having any one of the following criteria:
  • Poor symptom control: Asthma Control Questionnaire (ACQ) consistently > 1.5 or Asthma Control Test Questionnaire (ACT) < 20 (or "not well controlled" by National Asthma Education and Prevention Program [NAEPP] or Global Initiative for Asthma [GINA] guidelines over the 3 months or evaluation)
  • Frequent severe exacerbations: 2 or more bursts of systemic corticosteroids (CSs) (> 3 days each) in the previous year
  • Serious exacerbations: at least one hospitalization, intensive care unit stay or mechanical ventilation in the previous year
  • Airflow limitation: Forced expiratory volume in 1 second (FEV1) < 80% predicted (in the presence of reduced FEV1/forced vital capacity [FVC] defined as less than the normal lower limit) following a withhold of both short- and long-acting bronchodilators
  • Patients must not have experienced any immune related adverse event, including pneumonitis that led to permanent discontinuation of prior immunotherapy and/or required prolonged high dose of steroids
  • Patients must not have evidence of active infection requiring systemic therapy
  • Patients must not have received any live attenuated vaccinations within 28 days prior to sub-study registration

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Treatment (talazoparib, avelumab)
Patients receive talazoparib PO daily and avelumab IV over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
  • Drug: Avelumab
    Given IV
    Other names:
    • Bavencio
    • MSB-0010718C
    • MSB0010718C
  • Drug: Talazoparib
    Given PO
    Other names:
    • BMN 673
    • BMN-673
  • Drug: Talazoparib Tosylate
    Given PO
    Other names:
    • Talzenna

Recruiting Locations

University of South Alabama Mitchell Cancer Institute
Mobile, Alabama 36688
Contact:
Site Public Contact
251-445-9870
pfrancisco@usouthal.edu

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Contact:
Site Public Contact
501-686-8274

Kaiser Permanente-Anaheim
Anaheim, California 92806
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Kaiser Permanente-Baldwin Park
Baldwin Park, California 91706
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Kaiser Permanente-Bellflower
Bellflower, California 90706
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California 94704
Contact:
Site Public Contact
415-209-2686
bernicl@sutterhealth.org

Kaiser Permanente-Fontana
Fontana, California 92335
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Palo Alto Medical Foundation-Fremont
Fremont, California 94538
Contact:
Site Public Contact
415-209-2686
bernicl@sutterhealth.org

Kaiser Permanente-Fresno
Fresno, California 93720
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente - Harbor City
Harbor City, California 90710
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Kaiser Permanente-Irvine
Irvine, California 92618
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Kaiser Permanente Los Angeles Medical Center
Los Angeles, California 90027
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Kaiser Permanente-Cadillac
Los Angeles, California 90034
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Palo Alto Medical Foundation-Camino Division
Mountain View, California 94040
Contact:
Site Public Contact
415-209-2686
bernicl@sutterhealth.org

Kaiser Permanente-Oakland
Oakland, California 94611
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Palo Alto Medical Foundation Health Care
Palo Alto, California 94301
Contact:
Site Public Contact
415-209-2686
bernicl@sutterhealth.org

Kaiser Permanente - Panorama City
Panorama City, California 91402
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Kaiser Permanente-Riverside
Riverside, California 92505
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Kaiser Permanente-Roseville
Roseville, California 95661
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente Downtown Commons
Sacramento, California 95814
Contact:
Site Public Contact
877-642-4691
kpoct@kp.org

Sutter Medical Center Sacramento
Sacramento, California 95816
Contact:
Site Public Contact
415-209-2686
bernicl@sutterhealth.org

University of California Davis Comprehensive Cancer Center
Sacramento, California 95817
Contact:
Site Public Contact
916-734-3089

Kaiser Permanente-San Diego Zion
San Diego, California 92120
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

California Pacific Medical Center-Pacific Campus
San Francisco, California 94115
Contact:
Site Public Contact
415-209-2686
bernicl@sutterhealth.org

Kaiser Permanente-San Francisco
San Francisco, California 94115
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente-Santa Teresa-San Jose
San Jose, California 95119
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente San Leandro
San Leandro, California 94577
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente-San Marcos
San Marcos, California 92078
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Kaiser San Rafael-Gallinas
San Rafael, California 94903
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California 95051
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Palo Alto Medical Foundation-Santa Cruz
Santa Cruz, California 95065
Contact:
Site Public Contact
415-209-2686
bernicl@sutterhealth.org

Kaiser Permanente-South San Francisco
South San Francisco, California 94080
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California 94086
Contact:
Site Public Contact
415-209-2686
bernicl@sutterhealth.org

Kaiser Permanente-Vallejo
Vallejo, California 94589
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Sutter Solano Medical Center/Cancer Center
Vallejo, California 94589
Contact:
Site Public Contact
415-209-2686
bernicl@sutterhealth.org

Kaiser Permanente-Walnut Creek
Walnut Creek, California 94596
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Presbyterian Intercommunity Hospital
Whittier, California 90602
Contact:
Site Public Contact
562-698-0811

Kaiser Permanente-Woodland Hills
Woodland Hills, California 91367
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado 80012
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

University of Colorado Hospital
Aurora, Colorado 80045
Contact:
Site Public Contact
720-848-0650

Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado 80304
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

National Jewish Health-Main Campus
Denver, Colorado 80206
Contact:
Site Public Contact
877-225-5654
glicht@co-cancerresearch.org

Rocky Mountain Cancer Centers-Midtown
Denver, Colorado 80218
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

SCL Health Saint Joseph Hospital
Denver, Colorado 80218
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

Rocky Mountain Cancer Centers-Rose
Denver, Colorado 80220
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

Mountain Blue Cancer Care Center - Swedish
Englewood, Colorado 80113
Contact:
Site Public Contact
303-777-2663
WSCR@westernstatesncorp.org

Swedish Medical Center
Englewood, Colorado 80113
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

National Jewish Health-Western Hematology Oncology
Golden, Colorado 80401
Contact:
Site Public Contact
303-777-2663
glicht@co-cancerresearch.org

North Colorado Medical Center
Greeley, Colorado 80631
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

Good Samaritan Medical Center
Lafayette, Colorado 80026
Contact:
Site Public Contact
303-673-1622

Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado 80124
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

McKee Medical Center
Loveland, Colorado 80539
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

National Jewish Health-Northern Hematology Oncology
Thornton, Colorado 80260
Contact:
Site Public Contact
303-777-2663
glicht@co-cancerresearch.org

SCL Health Lutheran Medical Center
Wheat Ridge, Colorado 80033
Contact:
Site Public Contact
303-777-2663
ccrp@co-cancerresearch.org

Yale University
New Haven, Connecticut 06520
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut 06611
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

Veterans Affairs Connecticut Healthcare System-West Haven Campus
West Haven, Connecticut 06516
Contact:
Site Public Contact
203-937-3421

Bayhealth Hospital Kent Campus
Dover, Delaware 19901
Contact:
Site Public Contact
302-744-6755
mary_ella_quillen@bayhealth.org

Bayhealth Hospital Sussex Campus
Milford, Delaware 19963
Contact:
Site Public Contact
302-744-6755
jenni_glick@bayhealth.org

Moffitt Cancer Center
Tampa, Florida 33612
Contact:
Site Public Contact
800-679-0775
canceranswers@moffitt.org

Cleveland Clinic-Weston
Weston, Florida 33331
Contact:
Site Public Contact
954-659-5705
CancerAnswer@ccf.org

University Cancer and Blood Center LLC
Athens, Georgia 30607
Contact:
Site Public Contact
706-353-5006
research@universitycancer.com

Northside Hospital
Atlanta, Georgia 30342
Contact:
Site Public Contact
404-303-3355
ClinicalTrials@northside.com

Northeast Georgia Medical Center Braselton
Braselton, Georgia 30517
Contact:
Site Public Contact
770-219-8800
cancerpatient.navigator@nghs.com

Northside Hospital - Duluth
Duluth, Georgia 30096
Contact:
Site Public Contact
404-303-3355
Clinical.trials@northside.com

Northside Hospital - Gwinnett
Lawrenceville, Georgia 30046
Contact:
Site Public Contact
404-303-3355
Clinical.trials@northside.com

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia 31405
Contact:
Site Public Contact
912-819-5704
underberga@sjchs.org

Suburban Hematology Oncology Associates - Snellville
Snellville, Georgia 30078
Contact:
Site Public Contact
404-303-3355
Clinical.trials@northside.com

Hawaii Cancer Care - Savio
'Aiea, Hawaii 96701
Contact:
Site Public Contact
808-539-2273

Hawaii Cancer Care Inc-POB II
Honolulu, Hawaii 96813
Contact:
Site Public Contact
808-524-6115

Queen's Cancer Cenrer - POB I
Honolulu, Hawaii 96813
Contact:
Site Public Contact
808-532-0315

Queen's Medical Center
Honolulu, Hawaii 96813
Contact:
Site Public Contact
808-545-8548

Straub Clinic and Hospital
Honolulu, Hawaii 96813
Contact:
Site Public Contact
808-522-4333

Queen's Cancer Center - Kuakini
Honolulu, Hawaii 96817
Contact:
Site Public Contact
808-531-8521

Saint Luke's Mountain States Tumor Institute
Boise, Idaho 83712
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Kootenai Medical Center
Coeur d'Alene, Idaho 83814
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Saint Luke's Mountain States Tumor Institute - Fruitland
Fruitland, Idaho 83619
Contact:
Site Public Contact
208-381-8059
hallsc@slhs.org

Saint Luke's Mountain States Tumor Institute - Meridian
Meridian, Idaho 83642
Contact:
Site Public Contact
208-381-8059
hallsc@slhs.org

Saint Luke's Mountain States Tumor Institute - Nampa
Nampa, Idaho 83686
Contact:
Site Public Contact
208-381-8059
hallsc@slhs.org

Kootenai Cancer Center
Post Falls, Idaho 83854
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Kootenai Cancer Clinic
Sandpoint, Idaho 83864
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Saint Luke's Mountain States Tumor Institute-Twin Falls
Twin Falls, Idaho 83301
Contact:
Site Public Contact
208-381-8059
hallsc@slhs.org

Illinois CancerCare-Bloomington
Bloomington, Illinois 61704
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Canton
Canton, Illinois 61520
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Carthage
Carthage, Illinois 62321
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Northwestern University
Chicago, Illinois 60611
Contact:
Site Public Contact
312-695-1301
cancer@northwestern.edu

University of Chicago Comprehensive Cancer Center
Chicago, Illinois 60637
Contact:
Site Public Contact
773-702-8222
cancerclinicaltrials@bsd.uchicago.edu

Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
Contact:
Site Public Contact
217-876-4740
rhamrick@dmhhs.org

Illinois CancerCare-Dixon
Dixon, Illinois 61021
Contact:
Site Public Contact
815-285-7800

Crossroads Cancer Center
Effingham, Illinois 62401
Contact:
Site Public Contact
217-876-4740
rhamrick@dmhhs.org

Illinois CancerCare-Eureka
Eureka, Illinois 61530
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Galesburg
Galesburg, Illinois 61401
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois 61443
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Macomb
Macomb, Illinois 61455
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois 60451
Contact:
Site Public Contact
773-702-8222
cancerclinicaltrials@bsd.uchicago.edu

University of Chicago Medicine-Orland Park
Orland Park, Illinois 60462
Contact:
Site Public Contact
773-702-8222
cancerclinicaltrials@bsd.uchicago.edu

Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois 61350
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Pekin
Pekin, Illinois 61554
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Peoria
Peoria, Illinois 61615
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Peru
Peru, Illinois 61354
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Princeton
Princeton, Illinois 61356
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Genesis Cancer Center - Silvis
Silvis, Illinois 61282
Contact:
Site Public Contact
563-421-1908
turnerk@genesishealth.com

Southern Illinois University School of Medicine
Springfield, Illinois 62702
Contact:
Site Public Contact
217-545-7929

Springfield Clinic
Springfield, Illinois 62702
Contact:
Site Public Contact
800-444-7541

Memorial Medical Center
Springfield, Illinois 62781
Contact:
Site Public Contact
217-788-3528

Parkview Regional Medical Center
Fort Wayne, Indiana 46845
Contact:
Site Public Contact
877-784-4673

Goshen Center for Cancer Care
Goshen, Indiana 46526
Contact:
Site Public Contact
574-364-2973
cccois@goshenhealth.com

Franciscan Health Indianapolis
Indianapolis, Indiana 46237
Contact:
Site Public Contact
317-528-7060

Franciscan Health Mooresville
Mooresville, Indiana 46158
Contact:
Site Public Contact
317-834-3603

Memorial Hospital of South Bend
South Bend, Indiana 46601
Contact:
Site Public Contact
800-284-7370

Mary Greeley Medical Center
Ames, Iowa 50010
Contact:
Site Public Contact
515-956-4132

McFarland Clinic PC - Ames
Ames, Iowa 50010
Contact:
Site Public Contact
515-239-4734
ksoder@mcfarlandclinic.com

McFarland Clinic PC-Boone
Boone, Iowa 50036
Contact:
Site Public Contact
515-956-4132

Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa 50325
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

Mercy Cancer Center-West Lakes
Clive, Iowa 50325
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

Greater Regional Medical Center
Creston, Iowa 50801
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

Genesis Medical Center - East Campus
Davenport, Iowa 52803
Contact:
Site Public Contact
563-421-1908
turnerk@genesishealth.com

Genesis Cancer Care Institute
Davenport, Iowa 52804
Contact:
Site Public Contact
563-421-1908
turnerk@genesishealth.com

Iowa Cancer Specialists
Davenport, Iowa 52807
Contact:
Site Public Contact
563-421-1908
turnerk@genesishealth.com

Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa 50314
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

Mercy Medical Center - Des Moines
Des Moines, Iowa 50314
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

McFarland Clinic PC-Trinity Cancer Center
Fort Dodge, Iowa 50501
Contact:
Site Public Contact
515-956-4132

McFarland Clinic PC-Jefferson
Jefferson, Iowa 50129
Contact:
Site Public Contact
515-956-4132

McFarland Clinic PC-Marshalltown
Marshalltown, Iowa 50158
Contact:
Site Public Contact
515-956-4132

Mercy Medical Center-West Lakes
West Des Moines, Iowa 50266
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

HaysMed University of Kansas Health System
Hays, Kansas 67601
Contact:
Site Public Contact
785-623-5774

University of Kansas Cancer Center-Overland Park
Overland Park, Kansas 66210
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

Salina Regional Health Center
Salina, Kansas 67401
Contact:
Site Public Contact
785-452-7038
mleepers@srhc.com

University of Kansas Health System Saint Francis Campus
Topeka, Kansas 66606
Contact:
Site Public Contact
785-295-8000

University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas 66205
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

Saint Joseph Hospital East
Lexington, Kentucky 40509
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

University of Kentucky/Markey Cancer Center
Lexington, Kentucky 40536
Contact:
Site Public Contact
859-257-3379

Medical Center of Baton Rouge
Baton Rouge, Louisiana 70816
Contact:
Site Public Contact
225-761-5346
Camille.Beck@Ochsner.org

Ochsner High Grove
Baton Rouge, Louisiana 70836
Contact:
Site Public Contact
504-703-8712
Gregory.Johnstone@ochsner.org

Ochsner Medical Center Kenner
Kenner, Louisiana 70065
Contact:
Site Public Contact
504-464-8314
cris.molina@ochsner.org

Ochsner Medical Center Jefferson
New Orleans, Louisiana 70121
Contact:
Site Public Contact
504-703-8712
Gregory.Johnstone@ochsner.org

Western Maryland Regional Medical Center
Cumberland, Maryland 21502
Contact:
Site Public Contact
240-964-1400

Lahey Hospital and Medical Center
Burlington, Massachusetts 01805
Contact:
Site Public Contact
781-744-3421
cancerclinicaltrials@lahey.org

UMass Memorial Medical Center - University Campus
Worcester, Massachusetts 01655
Contact:
Site Public Contact
508-856-3216
cancer.research@umassmed.edu

Saint Joseph Mercy Hospital
Ann Arbor, Michigan 48106
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Bronson Battle Creek
Battle Creek, Michigan 49017
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Saint Joseph Mercy Brighton
Brighton, Michigan 48114
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

IHA Hematology Oncology Consultants-Canton
Canton, Michigan 48188
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Saint Joseph Mercy Canton
Canton, Michigan 48188
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

IHA Hematology Oncology Consultants-Chelsea
Chelsea, Michigan 48118
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Saint Joseph Mercy Chelsea
Chelsea, Michigan 48118
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan 48038
Contact:
Site Public Contact
313-916-3721
CTOResearch@hfhs.org

Henry Ford Hospital
Detroit, Michigan 48202
Contact:
Site Public Contact
313-916-3721
CTOResearch@hfhs.org

Ascension Saint John Hospital
Detroit, Michigan 48236
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Great Lakes Cancer Management Specialists-Doctors Park
East China Township, Michigan 48054
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Genesee Cancer and Blood Disease Treatment Center
Flint, Michigan 48503
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Genesee Hematology Oncology PC
Flint, Michigan 48503
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Genesys Hurley Cancer Institute
Flint, Michigan 48503
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Spectrum Health at Butterworth Campus
Grand Rapids, Michigan 49503
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Academic Hematology Oncology Specialists
Grosse Pointe Woods, Michigan 48236
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Grosse Pointe Woods, Michigan 48236
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Michigan Breast Specialists-Grosse Pointe Woods
Grosse Pointe Woods, Michigan 48236
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Allegiance Health
Jackson, Michigan 49201
Contact:
Site Public Contact
313-916-3721
CTOResearch@hfhs.org

West Michigan Cancer Center
Kalamazoo, Michigan 49007
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Sparrow Hospital
Lansing, Michigan 48912
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Hope Cancer Clinic
Livonia, Michigan 48154
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Saint Mary Mercy Hospital
Livonia, Michigan 48154
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Great Lakes Cancer Management Specialists-Macomb Medical Campus
Macomb, Michigan 48044
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Mercy Health Mercy Campus
Muskegon, Michigan 49444
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan 49444
Contact:
Site Public Contact
616-391-1230
connie.szczepanek@crcwm.org

Spectrum Health Reed City Hospital
Reed City, Michigan 49677
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Great Lakes Cancer Management Specialists-Rochester Hills
Rochester Hills, Michigan 48309
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Ascension Saint Mary's Hospital
Saginaw, Michigan 48601
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan 48604
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Marie Yeager Cancer Center
Saint Joseph, Michigan 49085
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Ascension Saint Joseph Hospital
Tawas City, Michigan 48764
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Munson Medical Center
Traverse City, Michigan 49684
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Great Lakes Cancer Management Specialists-Macomb Professional Building
Warren, Michigan 48093
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Saint John Macomb-Oakland Hospital
Warren, Michigan 48093
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Metro Health Hospital
Wyoming, Michigan 49519
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

IHA Hematology Oncology Consultants-Ann Arbor
Ypsilanti, Michigan 48197
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Sanford Joe Lueken Cancer Center
Bemidji, Minnesota 56601
Contact:
Site Public Contact
218-333-5000
OncologyClinicalTrialsFargo@sanfordhealth.org

Essentia Health - Deer River Clinic
Deer River, Minnesota 56636
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Essentia Health Cancer Center
Duluth, Minnesota 55805
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Essentia Health Hibbing Clinic
Hibbing, Minnesota 55746
Contact:
Site Public Contact
218-786-3308

Hennepin County Medical Center
Minneapolis, Minnesota 55415
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Minneapolis VA Medical Center
Minneapolis, Minnesota 55417
Contact:
Site Public Contact
612-467-2800

Essentia Health Sandstone
Sandstone, Minnesota 55072
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Essentia Health Virginia Clinic
Virginia, Minnesota 55792
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

University of Mississippi Medical Center
Jackson, Mississippi 39216
Contact:
Site Public Contact
601-815-6700

Saint Francis Medical Center
Cape Girardeau, Missouri 63703
Contact:
Site Public Contact
573-334-2230
sfmc@sfmc.net

Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri 63141
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Parkland Health Center - Farmington
Farmington, Missouri 63640
Contact:
Site Public Contact
314-996-5569

Truman Medical Centers
Kansas City, Missouri 64108
Contact:
Site Public Contact
816-404-4375

University of Kansas Cancer Center - North
Kansas City, Missouri 64154
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri 64064
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

University of Kansas Cancer Center at North Kansas City Hospital
North Kansas City, Missouri 64116
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

Washington University School of Medicine
Saint Louis, Missouri 63110
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Mercy Hospital South
Saint Louis, Missouri 63128
Contact:
Site Public Contact
janet.lesko@mercy.net

Siteman Cancer Center-South County
Saint Louis, Missouri 63129
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Missouri Baptist Medical Center
Saint Louis, Missouri 63131
Contact:
Site Public Contact
314-996-5569

Mercy Hospital Saint Louis
Saint Louis, Missouri 63141
Contact:
Site Public Contact
314-251-7066

Siteman Cancer Center at Saint Peters Hospital
Saint Peters, Missouri 63376
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri 63670
Contact:
Site Public Contact
314-996-5569

Mercy Hospital Springfield
Springfield, Missouri 65804
Contact:
Site Public Contact
417-269-4520

Missouri Baptist Sullivan Hospital
Sullivan, Missouri 63080
Contact:
Site Public Contact
314-996-5569

Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills, Missouri 63127
Contact:
Site Public Contact
314-996-5569

Bozeman Deaconess Hospital
Bozeman, Montana 59715
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana 59405
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

OptumCare Cancer Care at Oakey
Las Vegas, Nevada 89102
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada 89148
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

New Hampshire Oncology Hematology PA-Concord
Concord, New Hampshire 03301
Contact:
Site Public Contact
603-224-2556

Solinsky Center for Cancer Care
Manchester, New Hampshire 03103
Contact:
Site Public Contact
800-339-6484

Monmouth Medical Center
Long Branch, New Jersey 07740
Contact:
Site Public Contact
732-923-6564
mary.danish@rwjbh.org

Virtua Samson Cancer Center
Moorestown, New Jersey 08057
Contact:
Site Public Contact
856-247-7395

Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey 08876
Contact:
Site Public Contact
908-685-2481
Siby.Varughese@rwjbh.org

University of New Mexico Cancer Center
Albuquerque, New Mexico 87102
Contact:
Site Public Contact
505-925-0366
LByatt@nmcca.org

Presbyterian Kaseman Hospital
Albuquerque, New Mexico 87110
Contact:
Site Public Contact
505-559-6113
WBurman@phs.org

Memorial Medical Center - Las Cruces
Las Cruces, New Mexico 88011
Contact:
Site Public Contact
575-556-6545
Kim.Hoffman@lpnt.net

Presbyterian Rust Medical Center/Jorgensen Cancer Center
Rio Rancho, New Mexico 87124
Contact:
Site Public Contact
505-559-6113
WBurman@phs.org

Roswell Park Cancer Institute
Buffalo, New York 14263
Contact:
Site Public Contact
800-767-9355
askroswell@roswellpark.org

Mary Imogene Bassett Hospital
Cooperstown, New York 13326
Contact:
Site Public Contact
877-547-1750
CancerClinicalTrials@bassett.org

Arnot Ogden Medical Center/Falck Cancer Center
Elmira, New York 14905
Contact:
Site Public Contact
607-271-7000

University of Rochester
Rochester, New York 14642
Contact:
Site Public Contact
585-275-5830

Durham VA Medical Center
Durham, North Carolina 27705
Contact:
Site Public Contact
919-286-0411
VHADURcancertrials@va.gov

Duke University Medical Center
Durham, North Carolina 27710
Contact:
Site Public Contact
888-275-3853

Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina 28791
Contact:
Site Public Contact
828-696-4716
karen.morris@unchealth.unc.edu

Sanford Bismarck Medical Center
Bismarck, North Dakota 58501
Contact:
Site Public Contact
701-323-5760
OncologyClinicalTrialsFargo@sanfordhealth.org

Sanford Broadway Medical Center
Fargo, North Dakota 58122
Contact:
Site Public Contact
701-323-5760
OncologyClinicalTrialsFargo@sanfordhealth.org

Sanford Roger Maris Cancer Center
Fargo, North Dakota 58122
Contact:
Site Public Contact
701-234-6161
OncologyClinicalTrialsFargo@sanfordhealth.org

UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio 44122
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

Strecker Cancer Center-Belpre
Belpre, Ohio 45714
Contact:
Site Public Contact
800-523-3977
sheree@columbusccop.org

Adena Regional Medical Center
Chillicothe, Ohio 45601
Contact:
Site Public Contact
877-779-7585
sheree@columbusccop.org

Case Western Reserve University
Cleveland, Ohio 44106
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio 44111
Contact:
Site Public Contact
866-223-8100
TaussigResearch@ccf.org

Cleveland Clinic Foundation
Cleveland, Ohio 44195
Contact:
Site Public Contact
866-223-8100
TaussigResearch@ccf.org

Columbus Oncology and Hematology Associates Inc
Columbus, Ohio 43214
Contact:
Site Public Contact
614-488-2118
sheree@columbusccop.org

Grant Medical Center
Columbus, Ohio 43215
Contact:
Site Public Contact
614-566-4475
sheree@columbusccop.org

The Mark H Zangmeister Center
Columbus, Ohio 43219
Contact:
Site Public Contact
614-488-2118
sheree@columbusccop.org

Doctors Hospital
Columbus, Ohio 43228
Contact:
Site Public Contact
614-566-3275
sheree@columbusccop.org

Delaware Health Center-Grady Cancer Center
Delaware, Ohio 43015
Contact:
Site Public Contact
740-615-0227
sheree@columbusccop.org

Cleveland Clinic Cancer Center Mansfield
Mansfield, Ohio 44906
Contact:
Site Public Contact
866-223-8100
TaussigResearch@ccf.org

Marietta Memorial Hospital
Marietta, Ohio 45750
Contact:
Site Public Contact
800-523-3977
sheree@columbusccop.org

OhioHealth Marion General Hospital
Marion, Ohio 43302
Contact:
Site Public Contact
614-488-2118
sheree@columbusccop.org

Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio 44124
Contact:
Site Public Contact
866-223-8100
TaussigResearch@ccf.org

UH Seidman Cancer Center at Landerbrook Health Center
Mayfield Heights, Ohio 44124
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio 44060
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

UH Seidman Cancer Center at Southwest General Hospital
Middleburg Heights, Ohio 44130
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

Licking Memorial Hospital
Newark, Ohio 43055
Contact:
Site Public Contact
740-348-4000
sheree@columbusccop.org

University Hospitals Parma Medical Center
Parma, Ohio 44129
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

Southern Ohio Medical Center
Portsmouth, Ohio 45662
Contact:
Site Public Contact
614-488-2118
sheree@columbusccop.org

North Coast Cancer Care
Sandusky, Ohio 44870
Contact:
Site Public Contact
866-223-8100
TaussigResearch@ccf.org

UH Seidman Cancer Center at Firelands Regional Medical Center
Sandusky, Ohio 44870
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

Cleveland Clinic Cancer Center Strongsville
Strongsville, Ohio 44136
Contact:
Site Public Contact
866-223-8100
TaussigResearch@ccf.org

ProMedica Flower Hospital
Sylvania, Ohio 43560
Contact:
Site Public Contact
419-824-1842

University Hospitals Sharon Health Center
Wadsworth, Ohio 44281
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

South Pointe Hospital
Warrensville Heights, Ohio 44122
Contact:
Site Public Contact
866-223-8100
TaussigResearch@ccf.org

UH Seidman Cancer Center at Saint John Medical Center
Westlake, Ohio 44145
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

UHHS-Westlake Medical Center
Westlake, Ohio 44145
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

Cleveland Clinic Wooster Family Health and Surgery Center
Wooster, Ohio 44691
Contact:
Site Public Contact
866-223-8100
TaussigResearch@ccf.org

Genesis Healthcare System Cancer Care Center
Zanesville, Ohio 43701
Contact:
Site Public Contact
740-454-5232
sheree@columbusccop.org

University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
Contact:
Site Public Contact
405-271-8777
ou-clinical-trials@ouhsc.edu

Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma 73120
Contact:
Site Public Contact
405-752-3402

Kaiser Permanente Northwest
Portland, Oregon 97227
Contact:
Site Public Contact
503-335-2400
information@kpchr.org

Salem Hospital
Salem, Oregon 97301
Contact:
Site Public Contact
503-561-2618

Ephrata Cancer Center
Ephrata, Pennsylvania 17522
Contact:
Site Public Contact
717-721-4840

Adams Cancer Center
Gettysburg, Pennsylvania 17325
Contact:
Site Public Contact
877-441-7957

Cherry Tree Cancer Center
Hanover, Pennsylvania 17331
Contact:
Site Public Contact
877-441-7957

UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania 17109
Contact:
Site Public Contact
717-724-6765
klitchfield@PINNACLEHEALTH.org

Sechler Family Cancer Center
Lebanon, Pennsylvania 17042
Contact:
Site Public Contact
717-741-8303
doxenberg@wellspan.org

Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
Contact:
Site Public Contact
215-955-6084

Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
Contact:
Site Public Contact
215-728-4790

Temple University Hospital
Philadelphia, Pennsylvania 19140
Contact:
Site Public Contact
215-728-2983

University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania 15232
Contact:
Site Public Contact
412-647-8073

Pottstown Hospital
Pottstown, Pennsylvania 19464
Contact:
Site Public Contact
610-327-7544

UPMC Susquehanna
Williamsport, Pennsylvania 17701
Contact:
Site Public Contact
800-598-4282

WellSpan Health-York Cancer Center
York, Pennsylvania 17403
Contact:
Site Public Contact
877-441-7957

AnMed Health Cancer Center
Anderson, South Carolina 29621
Contact:
Site Public Contact
864-512-4651
rhonda.ballew@anmedhealth.org

Prisma Health Cancer Institute - Easley
Easley, South Carolina 29640
Contact:
Site Public Contact
864-522-2066
kim.williams3@prismahealth.org

Prisma Health Cancer Institute - Butternut
Greenville, South Carolina 29605
Contact:
Site Public Contact
864-522-2066
kim.williams3@prismahealth.org

Prisma Health Cancer Institute - Faris
Greenville, South Carolina 29605
Contact:
Site Public Contact
864-522-2066
kim.williams3@prismahealth.org

Prisma Health Cancer Institute - Eastside
Greenville, South Carolina 29615
Contact:
Site Public Contact
864-522-2066
kim.williams3@prismahealth.org

Prisma Health Cancer Institute - Greer
Greer, South Carolina 29650
Contact:
Site Public Contact
864-522-2066
kim.williams3@prismahealth.org

Prisma Health Cancer Institute - Seneca
Seneca, South Carolina 29672
Contact:
Site Public Contact
864-522-2066
kim.williams3@prismahealth.org

Prisma Health Cancer Institute - Spartanburg
Spartanburg, South Carolina 29307
Contact:
Site Public Contact
864-522-2066
kim.williams3@prismahealth.org

Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota 57104
Contact:
Site Public Contact
605-312-3320
OncologyClinicTrialsSF@sanfordhealth.org

Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
Contact:
Site Public Contact
605-312-3320
OncologyClinicalTrialsSF@SanfordHealth.org

The Don and Sybil Harrington Cancer Center
Amarillo, Texas 79106
Contact:
Site Public Contact
806-212-1985
gcravey@harringtoncc.org

Centra Lynchburg Hematology-Oncology Clinic Inc
Lynchburg, Virginia 24501
Contact:
Site Public Contact
434-200-5925
Kevin.Patel@centrahealth.com

Virginia Cancer Institute
Richmond, Virginia 23230
Contact:
Site Public Contact
804-287-3000
david.trent@comcast.net

VCU Massey Cancer Center at Stony Point
Richmond, Virginia 23235
Contact:
Site Public Contact
804-628-1939
mwellons@vcu.edu

Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia 23298
Contact:
Site Public Contact
804-628-1914
klcampbell@vcu.edu

VCU Community Memorial Health Center
South Hill, Virginia 23970
Contact:
Site Public Contact
434-774-2442
sherman.baker@vcuhealth.org

Shenandoah Oncology PC
Winchester, Virginia 22601
Contact:
Site Public Contact
540-662-1108
William.Houck@usoncology.com

Jefferson Healthcare
Port Townsend, Washington 98368
Contact:
Site Public Contact
360-344-3091

Edwards Comprehensive Cancer Center
Huntington, West Virginia 25701
Contact:
Site Public Contact
304-399-6617

Langlade Hospital and Cancer Center
Antigo, Wisconsin 54409
Contact:
Site Public Contact
715-623-9869
Juli.Alford@aspirus.org

Duluth Clinic Ashland
Ashland, Wisconsin 54806
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin 53105
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora Health Care Germantown Health Center
Germantown, Wisconsin 53022
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora Cancer Care-Grafton
Grafton, Wisconsin 53024
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin 54301
Contact:
Site Public Contact
920-433-8889
ewd_research_admin@hshs.org

Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin 54303
Contact:
Site Public Contact
920-433-8889
ewd_research_admin@hshs.org

Aurora BayCare Medical Center
Green Bay, Wisconsin 54311
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin 53142
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Gundersen Lutheran Medical Center
La Crosse, Wisconsin 54601
Contact:
Site Public Contact
608-775-2385
cancerctr@gundersenhealth.org

Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin 54143
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aspirus Medford Hospital
Medford, Wisconsin 54451
Contact:
Site Public Contact
715-847-2353
Beth.Knetter@aspirus.org

Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin 53051
Contact:
Site Public Contact
262-257-5100

Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin 53209
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin 53215
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Contact:
Site Public Contact
414-805-3666

Aurora Sinai Medical Center
Milwaukee, Wisconsin 53233
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin 54154
Contact:
Site Public Contact
920-433-8889
ewd_research_admin@hshs.org

Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin 54904
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora Cancer Care-Racine
Racine, Wisconsin 53406
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin 53081
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin 54235-1495
Contact:
Site Public Contact
920-433-8889
ewd_research_admin@hshs.org

Aurora Medical Center in Summit
Summit, Wisconsin 53066
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin 54241
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aspirus Regional Cancer Center
Wausau, Wisconsin 54401
Contact:
Site Public Contact
877-405-6866

Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin 53226
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora West Allis Medical Center
West Allis, Wisconsin 53227
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin 53095
Contact:
Site Public Contact
414-805-0505

Aspirus UW Cancer Center
Wisconsin Rapids, Wisconsin 54494
Contact:
Site Public Contact
715-422-7718

More Details

NCT ID
NCT04173507
Status
Recruiting
Sponsor
Southwest Oncology Group

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate the objective response rate (ORR) (confirmed and unconfirmed, complete and partial) with talazoparib plus avelumab in patients with stage IV or recurrent non-squamous non-small cell lung cancer bearing pathogenic STK11 genomic alterations that were previously-treated with anti-PD-1/PD-L1 therapy and platinum-based chemotherapy.

II. To evaluate disease control rate at 12 weeks (DCR12) after registration.

SECONDARY OBJECTIVES:

I. To evaluate investigator assessed progression-free survival (IA-PFS). II. To evaluate overall survival (OS). III. To evaluate duration of response (DOR) among responders. IV. To evaluate the frequency and severity of toxicities.

TRANSLATIONAL MEDICINE OBJECTIVES:

I. To collect, process, and bank cell-free deoxyribonucleic acid (DNA) (cfDNA) at baseline, cycle 3 day 1, progression, and end of treatment for future development of a proposal to evaluate comprehensive next-generation sequencing of circulating tumor DNA (ctDNA) and examine molecular mechanisms of resistance to talazoparib and avelumab.

II. To establish a tissue/blood repository from patients with refractory non-small cell lung cancer (NSCLC).

III. To evaluate clinical outcomes (ORR, IA-PFS, OS) in patients with concurrent somatic mutations in KEAP1 detected on the Foundation Medicine Inc. (FMI) panel from the LUNGMAP screening protocol.

IV. To evaluate clinical outcomes (ORR, IA-PFS, OS) in patients with concurrent mutations in ATM or other DNA damage response genes detected on the FMI panel from the LUNGMAP screening protocol.

V. To evaluate the association between tumor mutational burden (TMB) measured on the FMI panel from the LUNGMAP screening protocol and clinical outcomes (ORR, IA-PFS, OS).

OUTLINE:

Patients receive talazoparib orally (PO) daily and avelumab intravenously (IV) over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up until death or 3 years after sub-study registration.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.