Targeted Treatment for Advanced Non-Small Cell Lung Cancer That Has a MET Exon 14 Skipping Gene Change (An Expanded Lung-MAP Treatment Trial)

Purpose

This phase II Expanded Lung-MAP treatment trial tests tepotinib with or without ramucirumab for the treatment of patients with advanced non-small cell lung cancer that has spread from where it first started (primary site) to other places in the body (stage IV) or that has come back after a period of improvement (recurrent). Tepotinib is used in patients whose cancer has a mutated (changed) form of a gene called MET. It is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal MET protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving tepotinib with ramucirumab may lower the chance of the cancer from growing or spreading in patients with stage IV or recurrent non-small cell lung cancer.

Conditions

  • Recurrent Lung Non-Small Cell Carcinoma
  • Stage IV Lung Cancer AJCC v8

Eligibility

Eligible Ages
All ages
Eligible Genders
All
Accepts Healthy Volunteers
No

Criteria

Inclusion Criteria:

- Participants must have been assigned to S1900K by the Southwest Oncology Group
(SWOG) Statistics and Data Management Center (SDMC). Assignment to S1900K is
determined by the LUNGMAP protocol

- Participants must have documentation of NSCLC with a MET exon 14 skipping mutation
determined by tissue-based or blood-based (circulating tumor DNA [ctDNA]) next
generation sequencing (NGS) assay done within a laboratory with Clinical Laboratory
Improvement Act (CLIA), International Organization for Standardization (ISO)/
International Electrotechnical Commission (IEC), College of American Pathologists
(CAP), or similar certification. Documentation must either be:

- NGS test results from tissue submitted for LUNGMAP screening, or

- Submitted documentation in the LUNGMAP Rave Electronic Data Capture System of a
MET exon 14 skipping mutation from a previously completed tissue or blood-based
NGS test NOTE: Participants previously tested for and determined to have a MET
exon 14 skipping mutation, outside of LUNGMAP, must also submit tissue for
central Foundation Medicine (FMI) testing on the LUNGMAP screening protocol, if
available

- Participants must have measurable disease documented by CT or MRI. The CT from a
combined positron emission tomography (PET)/CT may be used to document measurable
disease ONLY if it is of diagnostic quality, otherwise, it may be used to document
non-measurable disease only. Measurable disease must be assessed within 28 days
prior to sub-study randomization. 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 randomization. All known
sites of disease must be assessed and documented on the Baseline Tumor Assessment
Form. Participants 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 randomization to be considered measurable

- Participants 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 randomization

- Participants must not have leptomeningeal disease, spinal cord compression or brain
metastases unless:

- Metastases have been locally treated and have remained clinically controlled
and asymptomatic for at least 3 days following the stereotactic radiation
and/or 14 days following whole brain radiation, and prior to sub-study
randomization, AND

- Participant has no residual neurological dysfunction and has been off
corticosteroids for at least 24 hours prior to sub-study randomization

- Participants must not have other known actionable oncogenic alterations, such as
(but not limited to) EGFR sensitizing mutations, EGFR T790M mutation, ALK gene
fusion, ROS1 gene rearrangement, RET gene rearrangement, NTRK rearrangement, HER2
mutation, KRAS activating mutations, and BRAF V600E mutation

- Participants must have progressed (in the opinion of the treating physician)
following the most recent line of therapy

- Participants must have received at least one line of systemic treatment for Stage IV
or recurrent NSCLC

- Participants must have recovered (=< grade 1) from any side effects of prior therapy
except alopecia and vitiligo

- Participants must not have received any prior systemic therapy (systemic
chemotherapy, immunotherapy or investigational drug) within 21 days prior to
sub-study randomization

- Participants must not have received treatment with prior MET inhibitor therapies
(e.g., crizotinib, tivantinib, savolitinib, tepotinib, cabozantinib, and foretinib).

- Participants must not have received treatment with prior angiogenesis inhibitor
therapies (including but not limited to bevacizumab and ramucirumab)

- Participants must not have a history of interstitial lung disease that required
steroid treatment

- Participants must not have received any radiation therapy within 7 days prior to
sub-study randomization with the exceptions of

- Stereotactic radiation to CNS metastases which must have been completed at
least 3 days prior to sub-study randomization and

- Palliative radiotherapy to bone metastases which must have been completed at
least 1 day prior to sub-study randomization

- Participants must not be planning to receive any concurrent chemotherapy,
immunotherapy, biologic or hormonal therapy for cancer treatment while receiving
treatment on this study

- Participants must not have had a major surgery within 14 days prior to sub-study
randomization. Participants must have fully recovered from the effects of prior
surgery in the opinion of the treating investigator

- Participants must not have a prior or concurrent malignancy whose natural history or
treatment (in the opinion of the treating physician) has the potential to interfere
with the safety or efficacy assessment of the investigational regimen

- Participants must be able to swallow tablets whole

- Absolute neutrophil count >= 1.5 x 10^3/uL (within 28 days prior to sub-study
randomization)

- Hemoglobin >= 9.0 g/dL (within 28 days prior to sub-study randomization)

- Platelets >= 100 x 10^3/uL (within 28 days prior to sub-study randomization)

- Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) unless history of
Gilbert's disease. Participants with history of Gilbert's disease must have total
bilirubin =< 5 x institutional ULN (within 28 days prior to sub-study randomization)

- Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) =< 2.5 ×
institutional ULN. Participants with history of liver metastasis must have AST =< 5
x ULN (within 28 days prior to sub-study randomization)

- Participants must have a serum creatinine =< the institutional upper limit of normal
(IULN) or calculated creatinine clearance >= 30 mL/min using the following
Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28
days prior to sub-study randomization

- Participants must have a cystatin C test performed to obtain baseline value within
28 days prior to sub-study randomization

- Participants' most recent Zubrod performance status must be 0-1 and be documented
within 28 days prior to sub-study randomization

- Participants must have a completed medical history and physical exam within 28 days
prior to sub-study randomization

- Participants must have adequate cardiac function. Participants with known history or
current symptoms of cardiac disease, or history of treatment with cardiotoxic
agents, must have a clinical risk assessment of cardiac function using the New York
Heart Association Functional Classification. To be eligible for this trial,
participants must be class 2B or better

- Participants with known human immunodeficiency virus (HIV)-infection must be on
effective anti-retroviral therapy and have undetectable viral load test on the most
recent test results obtained within 6 months prior to sub-study randomization

- Participants with evidence of chronic hepatitis B virus (HBV) infection must have
undetectable HBV viral load while on suppressive therapy on the most recent test
results obtained within 6 months prior to sub-study randomization, if indicated

- Participants with a history of hepatitis C virus (HCV) infection must have been
treated and cured. Participants currently being treated for HCV infection must have
undetectable HCV viral load test on the most recent test results obtained within 6
months prior to sub-study randomization, if indicated by the treating investigator

- Participants must not have cirrhosis at a level of Child-Pugh B (or worse) OR any
degree of cirrhosis AND a history of hepatic encephalopathy or clinically meaningful
ascites resulting from cirrhosis

- Participants must not have grade < 0 of peripheral edema within 28 days prior to
sub-study randomization

- Participants must not have experienced any arterial thromboembolic events, including
but not limited to transient ischemic attack or cerebrovascular accident within 6
months prior to sub-study randomization

- Participants must not have uncontrolled blood pressure and hypertension within 28
days prior to sub-study randomization

- Participants must not be pregnant or breastfeeding (nursing includes breast milk fed
to an infant by any means, including from the breast, milk expressed by hand, or
pumped). Individuals who are of reproductive potential must have agreed to use an
effective contraceptive method with details provided as a part of the consent
process. A person who has had menses at any time in the preceding 12 consecutive
months or who has semen likely to contain sperm is considered to be of "reproductive
potential." In addition to routine contraceptive methods, "effective contraception"
also includes refraining from sexual activity that might result in pregnancy and
surgery intended to prevent pregnancy (or with a side-effect of pregnancy
prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal
ligation/occlusion, and vasectomy with testing showing no sperm in the semen

- Participants must have a Lymphoscintigraphy scan performed within 28 days prior to
sub-study randomization

- Participants must also be offered participation in specimen banking. With
participant consent, specimens must be collected and submitted via the SWOG Specimen
Tracking System

- Participants must be informed of the investigational nature of this study and must
sign and give informed consent in accordance with institutional and federal
guidelines

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A: (Ramucirumab and tepotinib)
Patients receive ramucirumab IV over 30-60 minutes on day 1 of each cycle and tepotinib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo lymphoscintigraphy scan and CT scan and/or MRI throughout the trial. Patients also undergo blood sample collection while on study.
  • Procedure: Biospecimen Collection
    Undergo blood sample collection
    Other names:
    • Biological Sample Collection
    • Biospecimen Collected
    • Specimen Collection
  • Procedure: Computed Tomography
    Undergo CT scan
    Other names:
    • CAT
    • CAT Scan
    • Computed Axial Tomography
    • Computerized Axial Tomography
    • Computerized axial tomography (procedure)
    • Computerized Tomography
    • CT
    • CT Scan
    • tomography
  • Procedure: Lymphoscintigraphy
    Undergo lymphoscintigraphy scan
  • Procedure: Magnetic Resonance Imaging
    Undergo MRI
    Other names:
    • Magnetic Resonance
    • Magnetic resonance imaging (procedure)
    • Magnetic Resonance Imaging Scan
    • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    • MR
    • MR Imaging
    • MRI
    • MRI Scan
    • NMR Imaging
    • NMRI
    • Nuclear Magnetic Resonance Imaging
  • Biological: Ramucirumab
    Given IV
    Other names:
    • Anti-VEGFR-2 Fully Human Monoclonal Antibody IMC-1121B
    • Cyramza
    • IMC-1121B
    • LY3009806
    • Monoclonal Antibody HGS-ETR2
  • Drug: Tepotinib
    Given PO
    Other names:
    • c-Met Inhibitor MSC2156119J
    • EMD 1214063
    • EMD-1214063
    • EMD1214063
    • MSC2156119J
Active Comparator
Arm B: (Tepotinib)
Patients receive tepotinib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo lymphoscintigraphy scan and CT scan and/or MRI throughout the trial. Patients also undergo blood sample collection while on study.
  • Procedure: Biospecimen Collection
    Undergo blood sample collection
    Other names:
    • Biological Sample Collection
    • Biospecimen Collected
    • Specimen Collection
  • Procedure: Computed Tomography
    Undergo CT scan
    Other names:
    • CAT
    • CAT Scan
    • Computed Axial Tomography
    • Computerized Axial Tomography
    • Computerized axial tomography (procedure)
    • Computerized Tomography
    • CT
    • CT Scan
    • tomography
  • Procedure: Lymphoscintigraphy
    Undergo lymphoscintigraphy scan
  • Procedure: Magnetic Resonance Imaging
    Undergo MRI
    Other names:
    • Magnetic Resonance
    • Magnetic resonance imaging (procedure)
    • Magnetic Resonance Imaging Scan
    • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    • MR
    • MR Imaging
    • MRI
    • MRI Scan
    • NMR Imaging
    • NMRI
    • Nuclear Magnetic Resonance Imaging
  • Drug: Tepotinib
    Given PO
    Other names:
    • c-Met Inhibitor MSC2156119J
    • EMD 1214063
    • EMD-1214063
    • EMD1214063
    • MSC2156119J

Recruiting Locations

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas 72401
Contact:
Site Public Contact
870-936-7066
Emily.Carvell@bmhcc.org

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

Sutter Auburn Faith Hospital
Auburn, California 95602
Contact:
Site Public Contact
NCIclinicaltrials@sutterhealth.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
NCIclinicaltrials@sutterhealth.org

Tower Cancer Research Foundation
Beverly Hills, California 90211
Contact:
Site Public Contact
towercancerresearch@toweroncology.com

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
NCIclinicaltrials@sutterhealth.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 West Los Angeles
Los Angeles, California 90034
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Cedars Sinai Medical Center
Los Angeles, California 90048
Contact:
Site Public Contact
310-423-8965

Memorial Medical Center
Modesto, California 95355
Contact:
Site Public Contact
NCIclinicaltrials@sutterhealth.org

Kaiser Permanente-Ontario
Ontario, California 91761
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Palo Alto Medical Foundation Health Care
Palo Alto, California 94301
Contact:
Site Public Contact
NCIclinicaltrials@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

Sutter Roseville Medical Center
Roseville, California 95661
Contact:
Site Public Contact
NCIclinicaltrials@sutterhealth.org

Sutter Medical Center Sacramento
Sacramento, California 95816
Contact:
Site Public Contact
NCIclinicaltrials@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
NCIclinicaltrials@sutterhealth.org

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

Palo Alto Medical Foundation-Santa Cruz
Santa Cruz, California 95065
Contact:
Site Public Contact
NCIclinicaltrials@sutterhealth.org

Sutter Pacific Medical Foundation
Santa Rosa, California 95403
Contact:
Site Public Contact
415-209-2683
NCIclinicaltrials@sutterhealth.org

Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California 94086
Contact:
Site Public Contact
NCIclinicaltrials@sutterhealth.org

Cedars-Sinai Cancer - Tarzana
Tarzana, California 91356
Contact:
Site Public Contact
818-981-3818

Torrance Memorial Physician Network - Cancer Care
Torrance, California 90505
Contact:
Site Public Contact
310-750-3300
courtney.steeneken@tmphysicians.com

Sutter Solano Medical Center/Cancer Center
Vallejo, California 94589
Contact:
Site Public Contact
NCIclinicaltrials@sutterhealth.org

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

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

UCHealth Memorial Hospital Central
Colorado Springs, Colorado 80909
Contact:
Site Public Contact
719-365-2406

Memorial Hospital North
Colorado Springs, Colorado 80920
Contact:
Site Public Contact
719-364-6700

Poudre Valley Hospital
Fort Collins, Colorado 80524
Contact:
Site Public Contact
970-297-6150

Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado 80528
Contact:
Site Public Contact
protocols@swog.org

UCHealth Greeley Hospital
Greeley, Colorado 80631
Contact:
Site Public Contact
protocols@swog.org

Medical Center of the Rockies
Loveland, Colorado 80538
Contact:
Site Public Contact
970-203-7083

Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut 06418
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut 06824
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury, Connecticut 06033
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut 06830
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut 06437
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut 06105
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

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

Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut 06473
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

Smilow Cancer Hospital Care Center at Long Ridge
Stamford, Connecticut 06902
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut 06790
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

Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut 06708
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut 06385
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

Kaiser Permanente-Capitol Hill Medical Center
Washington, District of Columbia 20002
Contact:
Site Public Contact
301-548-5743

Northeast Georgia Medical Center-Gainesville
Gainesville, Georgia 30501
Contact:
Site Public Contact
770-219-8800
cancerpatient.navigator@nghs.com

Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho 83706
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho 83605
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

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

Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho 83687
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

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

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

Carle at The Riverfront
Danville, Illinois 61832
Contact:
Site Public Contact
800-446-5532
Research@Carle.com

Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Decatur Memorial Hospital
Decatur, Illinois 62526
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

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

Carle Physician Group-Effingham
Effingham, Illinois 62401
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Crossroads Cancer Center
Effingham, Illinois 62401
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

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

Edward Hines Jr VA Hospital
Hines, Illinois 60141
Contact:
Site Public Contact
708-202-8387

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

Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Cancer Care Center of O'Fallon
O'Fallon, Illinois 62269
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

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

Memorial Hospital East
Shiloh, Illinois 62269
Contact:
Site Public Contact
314-747-9912
dschwab@wustl.edu

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
217-528-7541
pallante.beth@mhsil.com

Carle Cancer Center
Urbana, Illinois 61801
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Illinois CancerCare - Washington
Washington, Illinois 61571
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana 46202
Contact:
Site Public Contact
317-278-5632
iutrials@iu.edu

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

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

Mission Cancer and Blood - Ankeny
Ankeny, Iowa 50023
Contact:
Site Public Contact
515-282-2921

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

Iowa Methodist Medical Center
Des Moines, Iowa 50309
Contact:
Site Public Contact
515-241-6727

Mission Cancer and Blood - Des Moines
Des Moines, Iowa 50309
Contact:
Site Public Contact
515-241-3305

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

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

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

University of Kansas Clinical Research Center
Fairway, Kansas 66205
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

HaysMed
Hays, Kansas 67601
Contact:
Site Public Contact
785-623-5774

University of Kansas Cancer Center
Kansas City, Kansas 66160
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

Lawrence Memorial Hospital
Lawrence, Kansas 66044
Contact:
Site Public Contact
785-505-2800
Stephanie.Norris@LMH.ORG

Olathe Health Cancer Center
Olathe, Kansas 66061
Contact:
Site Public Contact
913-355-3943
atheCCResearch@kumc.edu

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

University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas 66211
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:
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913-588-3671
KUCC_Navigation@kumc.edu

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

Kaiser Permanente-Woodlawn Medical Center
Baltimore, Maryland 21244
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301-816-7218

Kaiser Permanente-Gaithersburg Medical Center
Gaithersburg, Maryland 20879
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301-816-7218

Kaiser Permanente - Largo Medical Center
Largo, Maryland 20774
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301-816-7446

Kaiser Permanente Lutherville - Timonium Medical Center
Lutherville, Maryland 21093
Contact:
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410-847-3000

Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan 48106
Contact:
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734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan 48114
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734-712-7251
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Trinity Health Medical Center - Brighton
Brighton, Michigan 48114
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734-712-7251
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Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan 48188
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734-712-7251
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Trinity Health Medical Center - Canton
Canton, Michigan 48188
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734-712-7251
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Chelsea Hospital
Chelsea, Michigan 48118
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734-712-7251
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Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan 48118
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734-712-7251
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Genesee Cancer and Blood Disease Treatment Center
Flint, Michigan 48503
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810-762-8038
wstrong@ghci.org

Genesee Hematology Oncology PC
Flint, Michigan 48503
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810-762-8038
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Genesys Hurley Cancer Institute
Flint, Michigan 48503
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810-762-8038
wstrong@ghci.org

Hurley Medical Center
Flint, Michigan 48503
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810-762-8038
wstrong@ghci.org

Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan 48154
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734-712-7251
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Huron Gastroenterology PC
Ypsilanti, Michigan 48106
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734-712-7251
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Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan 48197
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734-712-7251
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Sanford Joe Lueken Cancer Center
Bemidji, Minnesota 56601
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218-333-5000
OncologyClinicalTrialsFargo@sanfordhealth.org

Essentia Health - Deer River Clinic
Deer River, Minnesota 56636
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218-786-3308
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Essentia Health Cancer Center
Duluth, Minnesota 55805
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218-786-3308
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Essentia Health Hibbing Clinic
Hibbing, Minnesota 55746
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218-786-3308

Essentia Health Sandstone
Sandstone, Minnesota 55072
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218-786-3308
CancerTrials@EssentiaHealth.org

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

Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi 39705
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901-226-1366
BCCclintrials@bmhcc.org

Baptist Cancer Center-Grenada
Grenada, Mississippi 38901
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901-226-1366
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Baptist Memorial Hospital and Cancer Center-Union County
New Albany, Mississippi 38652
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901-226-1366
BCCclintrials@bmhcc.org

Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi 38655
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901-226-1366
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Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi 38671
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901-226-1366
BCCclintrials@bmhcc.org

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

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

University Health Truman Medical Center
Kansas City, Missouri 64108
Contact:
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816-404-4375

Saint Luke's Hospital of Kansas City
Kansas City, Missouri 64111
Contact:
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913-948-5588
aroland@kccop.org

University of Kansas Cancer Center - North
Kansas City, Missouri 64154
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913-588-3671
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University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri 64064
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913-588-3671
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Saint Luke's East - Lee's Summit
Lee's Summit, Missouri 64086
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913-948-5588
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University of Kansas Cancer Center at North Kansas City Hospital
North Kansas City, Missouri 64116
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913-588-3671
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Washington University School of Medicine
Saint Louis, Missouri 63110
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800-600-3606
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Siteman Cancer Center-South County
Saint Louis, Missouri 63129
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800-600-3606
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Siteman Cancer Center at Christian Hospital
Saint Louis, Missouri 63136
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800-600-3606
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Siteman Cancer Center at Saint Peters Hospital
Saint Peters, Missouri 63376
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800-600-3606
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Community Hospital of Anaconda
Anaconda, Montana 59711
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406-969-6060
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Billings Clinic Cancer Center
Billings, Montana 59101
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800-996-2663
research@billingsclinic.org

Bozeman Health Deaconess Hospital
Bozeman, Montana 59715
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406-969-6060
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Benefis Sletten Cancer Institute
Great Falls, Montana 59405
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406-969-6060
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Kalispell Regional Medical Center
Kalispell, Montana 59901
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406-969-6060
mccinfo@mtcancer.org

Community Medical Center
Missoula, Montana 59804
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406-969-6060
mccinfo@mtcancer.org

OptumCare Cancer Care at Seven Hills
Henderson, Nevada 89052
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702-384-0013
research@sncrf.org

OptumCare Cancer Care at Charleston
Las Vegas, Nevada 89102
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702-384-0013
research@sncrf.org

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

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

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

Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey 07920
Contact:
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212-639-7592

Memorial Sloan Kettering Monmouth
Middletown, New Jersey 07748
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212-639-7592

Memorial Sloan Kettering Bergen
Montvale, New Jersey 07645
Contact:
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212-639-7592

Virtua Samson Cancer Center
Moorestown, New Jersey 08057
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856-206-4721
nctn@pennmedicine.upenn.edu

Virtua Voorhees
Voorhees, New Jersey 08043
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856-247-7395
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Memorial Sloan Kettering Commack
Commack, New York 11725
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212-639-7592

Mary Imogene Bassett Hospital
Cooperstown, New York 13326
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877-547-1750
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Memorial Sloan Kettering Westchester
Harrison, New York 10604
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212-639-7592

Memorial Sloan Kettering Cancer Center
New York, New York 10065
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212-639-7592

University of Rochester
Rochester, New York 14642
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585-275-5830

Memorial Sloan Kettering Nassau
Uniondale, New York 11553
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212-639-7592

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

Sanford Broadway Medical Center
Fargo, North Dakota 58122
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701-323-5760
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Sanford Roger Maris Cancer Center
Fargo, North Dakota 58122
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701-234-6161
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Aultman Health Foundation
Canton, Ohio 44710
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330-363-7274
ClinicalReserachDept@aultman.com

Miami Valley Hospital South
Centerville, Ohio 45459
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937-528-2900
clinical.trials@daytonncorp.org

Miami Valley Hospital
Dayton, Ohio 45409
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937-528-2900
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Premier Blood and Cancer Center
Dayton, Ohio 45409
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937-276-8320

Miami Valley Hospital North
Dayton, Ohio 45415
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937-528-2900
clinical.trials@daytonncorp.org

Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio 45005-1066
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937-528-2900
clinical.trials@daytonncorp.org

Miami Valley Cancer Care and Infusion
Greenville, Ohio 45331
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937-569-7515

ProMedica Flower Hospital
Sylvania, Ohio 43560
Contact:
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419-824-1842
PCIOncResearch@promedica.org

Upper Valley Medical Center
Troy, Ohio 45373
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937-528-2900
clinical.trials@daytonncorp.org

Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma 73505
Contact:
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877-231-4440

University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
Contact:
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405-271-8777
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Providence Newberg Medical Center
Newberg, Oregon 97132
Contact:
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503-215-2614
CanRsrchStudies@providence.org

Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon 97914
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406-969-6060
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Providence Willamette Falls Medical Center
Oregon City, Oregon 97045
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503-215-2614
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Providence Portland Medical Center
Portland, Oregon 97213
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503-215-2614
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Providence Saint Vincent Medical Center
Portland, Oregon 97225
Contact:
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503-215-2614
CanRsrchStudies@providence.org

Oregon Health and Science University
Portland, Oregon 97239
Contact:
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503-494-1080
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WellSpan Medical Oncology and Hematology
Chambersburg, Pennsylvania 17201
Contact:
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717-217-6020

Geisinger Medical Center
Danville, Pennsylvania 17822
Contact:
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570-271-5251
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Ephrata Cancer Center
Ephrata, Pennsylvania 17522
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717-721-4840

Adams Cancer Center
Gettysburg, Pennsylvania 17325
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877-441-7957

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

Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania 17837
Contact:
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570-374-8555
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Community Medical Center
Scranton, Pennsylvania 18510
Contact:
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570-703-4768
HemonCCTrials@geisinger.edu

Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania 18711
Contact:
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570-271-5251
HemonCCTrials@geisinger.edu

Cancer Care Associates of York
York, Pennsylvania 17403
Contact:
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717-741-9229

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

WellSpan Health-York Hospital
York, Pennsylvania 17403
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877-441-7957

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

Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
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605-312-3320
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Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee 38017
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901-226-1366
BCCclintrials@bmhcc.org

Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee 38120
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901-226-1366
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The Don and Sybil Harrington Cancer Center
Amarillo, Texas 79106
Contact:
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806-212-1985
Gina.Cravey@bsahs.org

Kaiser Permanente Tysons Corner Medical Center
McLean, Virginia 22102
Contact:
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240-632-4284

Kaiser Permanente-Caton Hill Medical Center
Woodbridge, Virginia 22192
Contact:
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Leslie.K.Greenberg@kp.org

Swedish Cancer Institute-Edmonds
Edmonds, Washington 98026
Contact:
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206-215-3086
PCRC-NCORP@Swedish.org

Swedish Cancer Institute-Issaquah
Issaquah, Washington 98029
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206-215-3086
PCRC-NCORP@Swedish.org

Swedish Medical Center-First Hill
Seattle, Washington 98122
Contact:
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206-215-3086
PCRC-NCORP@Swedish.org

Edwards Comprehensive Cancer Center
Huntington, West Virginia 25701
Contact:
Site Public Contact
304-399-6566
Christina.Cole@chhi.org

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

Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin 54701
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

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

Marshfield Medical Center-Marshfield
Marshfield, Wisconsin 54449
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin 54548
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin 54482
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Marshfield Medical Center - Weston
Weston, Wisconsin 54476
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

More Details

NCT ID
NCT06031688
Status
Recruiting
Sponsor
SWOG Cancer Research Network

Detailed Description

PRIMARY OBJECTIVE: I. To compare the response rate (confirmed or unconfirmed, complete or impartial) between participants with MET exon 14 skipping positive non-small cell lung cancer (NSCLC) randomized to tepotinib with or without ramucirumab. SECONDARY OBJECTIVES: I. To compare the frequency of all-grade treatment- related peripheral edema as defined by Common Terminology Criteria for Adverse Events (CTCAE) between the arms. II. To evaluate the frequency and severity of toxicities within each arm. III. To compare progression-free survival between the arms. IV. To compare overall survival between the arms. V. To estimate the duration of response (DoR) among responders within each arm. TRANSLATIONAL MEDICINE OBJECTIVE: I. To establish a tissue/blood repository for participants with MET exon 14 skipping non-small cell lung cancer (NSCLC). OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive ramucirumab intravenously (IV) over 30-60 minutes on day 1 of each cycle and tepotinib orally (PO) once daily (QD) on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive tepotinib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo lymphoscintigraphy scan and computed tomography (CT) scan and/or magnetic resonance imaging (MRI) throughout the trial. Patients also undergo blood sample collection while on study. After completion of study treatment, patients are followed-up every 12 weeks or more often as clinically indicated until progression and then every 6 months for 2 years and at the end of 3 years from date of sub-study randomization.