Testing the Addition of an Antibody to Standard Chemoradiation Followed by the Antibody for One Year to Standard Chemoradiation Followed by One Year of the Antibody in Patients With Unresectable Stage III Non-Small Cell Lung Cancer
Purpose
This phase III trial studies how well an antibody (durvalumab) with chemotherapy and radiation therapy (chemoradiation) works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This study is being done to see if adding durvalumab to standard chemoradiation followed by additional durvalumab can extend patients life and/or prevent the tumor from coming back compared to the usual approach of chemoradiation alone followed by durvalumab.
Conditions
- Recurrent Lung Non-Small Cell Carcinoma
- Stage III Lung Cancer AJCC v8
- Stage IIIA Lung Cancer AJCC v8
- Stage IIIB Lung Cancer AJCC v8
- Stage IIIC Lung Cancer AJCC v8
- Unresectable Lung Non-Small Cell Carcinoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- STEP 1 INCLUSION ELIGIBILITY CRITERIA - CONCURRENT THERAPY - Patient must be >= 18 years old - Patient must have one of the following: - Newly diagnosed stage IIIA/B/C non-small cell lung cancer (NSCLC) (per the American Joint Committee on Cancer [AJCC] 8th edition) that is unresectable and is histologically and/or cytologically confirmed - Nodal recurrence after surgery for early stage NSCLC - Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Patient must have a body weight > 30 kg - Patient must not have unintentional weight loss > 10% within 30 days prior to registration - Patient must have a baseline electrocardiography (ECG) obtained within 6 weeks prior to registration - Patient must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. Baseline imaging assessments and measurements used to evaluate all measurable or non-measurable sites of disease must be done within 4 weeks prior to registration - Absolute neutrophil count (ANC) >= 1500 cells/uL (obtained =< 7 days prior to registration) - White blood cells (WBC) counts >= 2500/uL (obtained =< 7 days prior to registration) - Platelet count >= 100,000/uL (obtained =< 7 days prior to registration) - Hemoglobin >= 9.0 g/dL (obtained =< 7 days prior to registration) - Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) with the following exception: patients with known Gilbert disease who have serum bilirubin level < 3 x ULN may be enrolled (obtained =< 7 days prior to registration) - Aspartate aminotransferase (AST) and alanine transaminase (ALT) =< 3.0 x institutional ULN (obtained =< 7 days prior to registration) - Serum creatinine =< 1.5 x institutional ULN or creatinine clearance >= 45 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation (obtained =< 7 days prior to registration) - Patient must have pulmonary function tests (PFTs) with both forced expiratory volume in 1 second (FEV1) and diffusion capacity of the lung for carbon monoxide (DLCO) >= 40% of predicted, obtained within 5 months prior to registration - Patient is expected to have lung volume (V)20 of =< 35%, after radiation oncologist views pre-treatment work up - Patients with nodal recurrence after surgery for early-stage NSCLC are eligible if the following criteria are met: - No prior chemotherapy or radiation was ever administered for this lung cancer originally or for recurrence prior to entering this protocol - Prior curative-intent surgery was at least 90 days prior to the nodal recurrence - No prior radiation was administered to the region of study cancer that would cause overlap of treatment fields - Patients who are human immunodeficiency virus (HIV) positive may participate in the study IF they meet all of the following eligibility requirements: - They must be stable on their anti-retroviral regimen, and they must be healthy from an HIV perspective - They must have a CD4 count of greater than 250 cells/mcL, obtained within 6 months prior to registration - They must not be receiving prophylactic therapy for an opportunistic infection - Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Patients must not have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to registration - Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. - All patients of childbearing potential must have a negative blood test or urine study, with a minimum sensitivity 50 mlU/L or equivalent units of HCG, within 7 days prior to registration to rule out pregnancy. A patient of childbearing potential is anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months). - Patients must not expected to conceive or father children by using accepted and highly effective method(s) of contraception during sexual intercourse for at least one week prior to the start of treatment, during protocol treatment, and continue for 90 days after the last dose of protocol treatment. - Highly effective methods of contraception include Etonogestrel-releasing implants (Implanon or Norplant), Intravaginal: Ethinylestradiol/etonogestrel-releasing intravaginal devices: e.g., NuvaRing, injection: Medroxyprogesterone injection: e.g., Depo-Provera, combined pill: Normal and low dose combined oral contraceptive pill, patch: Norelgestromin/ethinylestradiol-releasing transdermal system: e.g., Ortho Evra, Minipillc: Progesterone based oral contraceptive pill using desogestrel: Cerazette is currently the only highly effective progesterone based pill - Methods that are considered inadequate include male or female condom with or without spermicide; female cap, diaphragm, or sponge with or without spermicide; non-copper containing intrauterine device; progestogen-only oral hormonal contraceptive pills where inhibition of ovulation is not the primary mode of action [excluding Cerazette/desogestrel which is considered highly effective]; and triphasic combined oral contraceptive pills) - STEP 2 INCLUSION ELIGIBILITY CRITERIA - CONSOLIDATION - Patients with any > grade 2 non-hematologic or > grade 3 hematologic toxicities must recover to grade 2 (or less) within 45 days after the end of Step 1 concurrent chemo/radiation, with the exception of alopecia and vitiligo
Exclusion Criteria
- STEP 1 EXCLUSION ELIGIBILITY CRITERIA - CONCURRENT THERAPY - Patient must not have any active, known or suspected autoimmune disease and neuromuscular paraneoplastic syndromes including, but not limited to myasthenia gravis, Lambert-Eaton myasthenic syndrome, limbic encephalitis, myositis, Guillain-Barré, systemic lupus erythematosus, and systemic sclerosis. Patients with type I diabetes mellitus requiring insulin, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are eligible - Patient must not have a history of active hepatitis B (chronic or acute) or hepatitis C infection. Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for hepatitis C virus ribonucleic acid (HCV RNA) - Patient must not have a known active tuberculosis infection - Patient must not have any severe infections within 4 weeks prior to registration including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia - Patient must not have signs or symptoms of severe infection (sepsis) within 2 weeks prior registration - Patient must not have been treated with systemic immunostimulatory agents (including but not limited to interferon-a [IFN-a], interleukin [IL]-2) within 6 weeks or five half-lives of the drug (whichever is shorter) prior to registration; or treated with an investigational agent within 4 weeks prior to registration (or within five half-lives of the investigational agent, whichever is longer) - Patient must not have a history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins - Patient must not have been treated with systemic immunosuppressive medications (equivalent to > 10 mg prednisone per day) or other immunosuppressive medications within 7 days prior to registration. Inhaled or topical steroids and adrenal replacement steroid doses equivalent to > 10 mg prednisone per day are permitted in the absence of active autoimmune disease - Patient must not have had a prior allogeneic bone marrow transplantation or prior solid organ transplantation - Patient must not have a history of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan within 4 weeks prior to registration - Patient must not have had any prior systemic treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways - Patient with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment and severity of cardiac symptoms. Symptoms should be stable over the past 3 months. Specifically, patient must not have coronary artery bypass grafting, myocardial infarction, acute coronary syndrome severe/unstable angina, stroke, transient ischemic attack, or heart failure hospitalization within 3 months prior to registration - Patient must not have an uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events (AEs) or compromise the ability of the patient to give written informed consent - Patient must not have received a live, attenuated vaccine within 4 weeks prior to registration - Patient must not have had past radiation to the current intended treatment site - Patient must not donate blood or sperm while on study treatment - STEP 2 EXCLUSION ELIGIBILITY CRITERIA - CONSOLIDATION - Patient must not receive any non-protocol anti-cancer therapy after the end of Step 1 chemo/radiation or during Step 2 consolidation - Patients with suspected cases of >= grade 2 pneumonitis (non-infectious) are not eligible for Step 2 consolidative MEDI4736 (durvalumab) and will proceed onto follow-up instead - Patient must not have disease progression on the first post-treatment (Step 1 for concurrent chemo/radiation) chest CT scan, which must be obtained within 14 days after the last dose of radiation therapy. If so, the patient is not eligible for Step 2 consolidative MEDI4736 (durvalumab) and will proceed onto follow-up instead
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Arm A (durvalumab, chemotherapy, durvalumab) |
STEP 1 (CONCURRENT THERAPY): Patients receive durvalumab IV over 60 minutes on days 1 and 15 of cycle 1 and day 1 of cycle 2. Patients also receive 1 of 3 treatment regimens per investigator choice: 1) etoposide IV over 60 minutes on days 1-5 and cisplatin IV over 60 minutes on days 1 and 8 every 28 days for 2 cycles; 2) pemetrexed disodium IV over 60 minutes and cisplatin IV over 60-120 minutes on day 1 every 21 days for 2 cycles; or 3) paclitaxel IV over 60 minutes and carboplatin IV over 30 minutes on day 1 every 7 days for 6 cycles. Treatment continues in the absence of disease progression or unacceptable toxicity. Beginning on day 1 of chemotherapy, patients receive radiation therapy 5 days a week for 6 weeks. STEP 2 (CONSOLIDATION THERAPY): Within 14 days after the last dose of radiation (from Step 1), all patients then receive durvalumab IV over 60 minutes on day 1. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. |
|
Active Comparator Arm B (chemotherapy, durvalumab) |
STEP 1 (CONCURRENT THERAPY): Patients receive 1 of 3 investigator's choice treatment regimens and radiation therapy as in Arm A. STEP 2 (CONSOLIDATION THERAPY): Within 14 days after the last dose of radiation (from Step 1), all patients then receive durvalumab IV over 60 minutes on day 1. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. |
|
Recruiting Locations
Anchorage, Alaska 98508
Anchorage, Alaska 99504
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Fairbanks, Alaska 99701
Kingman, Arizona 86401
Phoenix, Arizona 85004
Tucson, Arizona 85704
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520-694-8900
Tucson, Arizona 85719
Tucson, Arizona 85719
Fort Smith, Arkansas 72903
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800-378-9373
Jonesboro, Arkansas 72401
Little Rock, Arkansas 72205
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501-686-8274
Arroyo Grande, California 93420
Arroyo Grande, California 93420
Auburn, California 95602
Auburn, California 95603
Berkeley, California 94704
Burbank, California 91505
Burlingame, California 94010
Cameron Park, California 95682
Carmichael, California 95608
Carmichael, California 95608
Castro Valley, California 94546
Davis, California 95616
Elk Grove, California 95758
Fremont, California 94538
Marysville, California 95901
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530-749-4400
Modesto, California 95355
Mountain View, California 94040
Mountain View, California 94040
Novato, California 94945
Palo Alto, California 94301
Rocklin, California 95765
Roseville, California 95661
Roseville, California 95661
Sacramento, California 95816
Sacramento, California 95816
Sacramento, California 95817
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916-734-3089
San Francisco, California 94115
San Luis Obispo, California 93401
Santa Cruz, California 95065
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Vacaville, California 95687
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Woodland, California 95695
Aurora, Colorado 80012
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Boulder, Colorado 80303
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Colorado Springs, Colorado 80923
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Denver, Colorado 80218
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Lakewood, Colorado 80228
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Thornton, Colorado 80260
Dover, Delaware 19901
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Milford, Delaware 19963
Newark, Delaware 19713
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Newark, Delaware 19718
Rehoboth Beach, Delaware 19971
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Garden City, Kansas 67846
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Bardstown, Kentucky 40004
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Lexington, Kentucky 40504
Lexington, Kentucky 40504
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Baton Rouge, Louisiana 70836
Covington, Louisiana 70433
New Orleans, Louisiana 70121
Shreveport, Louisiana 71105
Bangor, Maine 04401
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Bath, Maine 04530
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Peabody, Massachusetts 01960
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Ann Arbor, Michigan 48106
Battle Creek, Michigan 49017
Brighton, Michigan 48114
Brighton, Michigan 48114
Canton, Michigan 48188
Canton, Michigan 48188
Caro, Michigan 48723
Chelsea, Michigan 48118
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Clarkston, Michigan 48346
Clarkston, Michigan 48346
Clarkston, Michigan 48346
Detroit, Michigan 48236
East China Township, Michigan 48054
Farmington Hills, Michigan 48334
Flint, Michigan 48503
Flint, Michigan 48503
Flint, Michigan 48503
Flint, Michigan 48503
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Grosse Pointe Woods, Michigan 48236
Grosse Pointe Woods, Michigan 48236
Grosse Pointe Woods, Michigan 48236
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49009
Kalamazoo, Michigan 49048
Lansing, Michigan 48912
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517-364-9400
Livonia, Michigan 48154
Macomb, Michigan 48044
Macomb, Michigan 48044
Macomb, Michigan 48044
Madison Heights, Michigan 48071
Marlette, Michigan 48453
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Niles, Michigan 49120
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616-391-1230
Norton Shores, Michigan 49444
Novi, Michigan 48374
Pontiac, Michigan 48341
Pontiac, Michigan 48341
Pontiac, Michigan 48341
Pontiac, Michigan 48341
Reed City, Michigan 49677
Saginaw, Michigan 48601
Saginaw, Michigan 48604
Saint Joseph, Michigan 49085
Saint Joseph, Michigan 49085
Southfield, Michigan 48075
Sterling Heights, Michigan 48312
Tawas City, Michigan 48764
Traverse City, Michigan 49684
Troy, Michigan 48098
Warren, Michigan 48088
Warren, Michigan 48093
Warren, Michigan 48093
Warren, Michigan 48093
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West Branch, Michigan 48661
Wyoming, Michigan 49519
Ypsilanti, Michigan 48106
Ypsilanti, Michigan 48197
Aitkin, Minnesota 56431
Baxter, Minnesota 56425
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218-828-2880
Bemidji, Minnesota 56601
Brainerd, Minnesota 56401
Burnsville, Minnesota 55337
Cambridge, Minnesota 55008
Coon Rapids, Minnesota 55433
Deer River, Minnesota 56636
Detroit Lakes, Minnesota 56501
Duluth, Minnesota 55805
Duluth, Minnesota 55805
Duluth, Minnesota 55805
Edina, Minnesota 55435
Ely, Minnesota 55731
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218-365-7900
Fosston, Minnesota 56542
Fridley, Minnesota 55432
Hibbing, Minnesota 55746
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218-786-3308
International Falls, Minnesota 56649
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218-283-9431
Maple Grove, Minnesota 55369
Maplewood, Minnesota 55109
Maplewood, Minnesota 55109
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55415
Minneapolis, Minnesota 55454
Monticello, Minnesota 55362
Moose Lake, Minnesota 55767
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218-485-4481
New Ulm, Minnesota 56073
Park Rapids, Minnesota 56470
Princeton, Minnesota 55371
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Sandstone, Minnesota 55072
Shakopee, Minnesota 55379
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Thief River Falls, Minnesota 56701
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605-312-3320
Virginia, Minnesota 55792
Waconia, Minnesota 55387
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Wyoming, Minnesota 55092
Columbus, Mississippi 39705
Grenada, Mississippi 38901
Hattiesburg, Mississippi 39401
Jackson, Mississippi 39216
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601-815-6700
New Albany, Mississippi 38652
Oxford, Mississippi 38655
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Ballwin, Missouri 63011
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314-251-7058
Bolivar, Missouri 65613
Branson, Missouri 65616
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417-269-4520
Cape Girardeau, Missouri 63703
Cape Girardeau, Missouri 63703
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573-651-5550
Farmington, Missouri 63640
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314-996-5569
Jefferson City, Missouri 65109
Joplin, Missouri 64804
Joplin, Missouri 64804
Rolla, Missouri 65401
Rolla, Missouri 65401
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573-458-6379
Saint Joseph, Missouri 64506
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314-353-1870
Saint Louis, Missouri 63131
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314-996-5569
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314-251-7066
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314-996-5569
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417-269-4520
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417-269-4520
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314-996-5569
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314-996-5569
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636-390-1600
Anaconda, Montana 59711
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Great Falls, Montana 59405
Great Falls, Montana 59405
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Missoula, Montana 59804
Kearney, Nebraska 68847
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Lincoln, Nebraska 68516
Lincoln, Nebraska 68516
Omaha, Nebraska 68114
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402-334-4773
Omaha, Nebraska 68114
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402-354-5144
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Carson City, Nevada 89703
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Henderson, Nevada 89052
Henderson, Nevada 89052
Henderson, Nevada 89052
Henderson, Nevada 89052
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Henderson, Nevada 89074
Henderson, Nevada 89074
Henderson, Nevada 89074
Las Vegas, Nevada 89102
Las Vegas, Nevada 89102
Las Vegas, Nevada 89103
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Las Vegas, Nevada 89109
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Las Vegas, Nevada 89113
Las Vegas, Nevada 89119
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Las Vegas, Nevada 89135
Las Vegas, Nevada 89144
Las Vegas, Nevada 89144
Las Vegas, Nevada 89144
Las Vegas, Nevada 89148-2405
Las Vegas, Nevada 89148
Las Vegas, Nevada 89148
Las Vegas, Nevada 89148
Las Vegas, Nevada 89169
Las Vegas, Nevada 89169
Pahrump, Nevada 89048
Reno, Nevada 89502
Reno, Nevada 89503
Reno, Nevada 89509
Concord, New Hampshire 03301
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603-224-2556
Lebanon, New Hampshire 03756
Manchester, New Hampshire 03103
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800-339-6484
Hamilton, New Jersey 08690
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609-631-6946
Jersey City, New Jersey 07302
Lakewood, New Jersey 08701
Livingston, New Jersey 07039
Long Branch, New Jersey 07740
Moorestown, New Jersey 08057
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856-247-7395
New Brunswick, New Jersey 08903
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732-235-7356
Somerville, New Jersey 08876
Toms River, New Jersey 08755
Voorhees, New Jersey 08043
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856-247-7395
Albuquerque, New Mexico 87102
Auburn, New York 13021
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315-472-7504
Bronx, New York 10468
Canandaigua, New York 14424
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585-396-6161
East Syracuse, New York 13057
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315-472-7504
Glens Falls, New York 12801
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518-926-6700
Middletown, New York 10940
Oneida, New York 13421
Oneida, New York 13421
Oswego, New York 13126
Oswego, New York 13126
Rochester, New York 14620
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585-341-8113
Rochester, New York 14642
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585-275-5830
Stony Brook, New York 11794
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800-862-2215
Syracuse, New York 13210
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315-464-5476
Syracuse, New York 13210
Syracuse, New York 13215
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315-472-7504
Cary, North Carolina 27518
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919-781-7070
Durham, North Carolina 27710
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888-275-3853
Greenville, North Carolina 27834
Hendersonville, North Carolina 28791
Kenansville, North Carolina 28349
Kinston, North Carolina 28501
New Bern, North Carolina 28561
Pinehurst, North Carolina 28374
Raleigh, North Carolina 27607
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919-785-4878
Raleigh, North Carolina 27609
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919-862-5400
Richlands, North Carolina 28574
Bismarck, North Dakota 58501
Fargo, North Dakota 58103
Fargo, North Dakota 58103
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701-234-6161
Fargo, North Dakota 58103
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605-312-3320
Fargo, North Dakota 58104
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800-437-4010
Fargo, North Dakota 58122
Fargo, North Dakota 58122
Jamestown, North Dakota 58401
Akron, Ohio 44304
Barberton, Ohio 44203
Beavercreek, Ohio 45431
Belpre, Ohio 45714
Boardman, Ohio 44512
Canton, Ohio 44708
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888-293-4673
Centerville, Ohio 45459
Centerville, Ohio 45459
Chillicothe, Ohio 45601
Cincinnati, Ohio 45220
Cincinnati, Ohio 45236
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Cincinnati, Ohio 45255
Cleveland, Ohio 44109
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Cleveland, Ohio 44195
Columbus, Ohio 43213
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Columbus, Ohio 43215
Columbus, Ohio 43219
Columbus, Ohio 43222
Columbus, Ohio 43228
Dayton, Ohio 45409
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937-276-8320
Dayton, Ohio 45409
Dayton, Ohio 45415
Dayton, Ohio 45415
Delaware, Ohio 43015
Delaware, Ohio 43015
Dublin, Ohio 43016
Dublin, Ohio 43016
Findlay, Ohio 45840
Findlay, Ohio 45840
Findlay, Ohio 45840
Franklin, Ohio 45005-1066
Franklin, Ohio 45005
Gahanna, Ohio 43230
Greenville, Ohio 45331
Greenville, Ohio 45331
Grove City, Ohio 43123
Grove City, Ohio 43123
Independence, Ohio 44131
Kettering, Ohio 45409
Kettering, Ohio 45429
Lancaster, Ohio 43130
Lima, Ohio 45801
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419-226-9617
Mansfield, Ohio 44903
Mansfield, Ohio 44906
Marietta, Ohio 45750
Marion, Ohio 43302
Mayfield Heights, Ohio 44124
Medina, Ohio 44256
Mount Vernon, Ohio 43050
New Albany, Ohio 43054
Newark, Ohio 43055
Newark, Ohio 43055
Perrysburg, Ohio 43551
Portsmouth, Ohio 45662
Sandusky, Ohio 44870
Springfield, Ohio 45504
Springfield, Ohio 45505
Strongsville, Ohio 44136
Toledo, Ohio 43608
Toledo, Ohio 43623
Troy, Ohio 45373
Troy, Ohio 45373
Warrensville Heights, Ohio 44122
Warren, Ohio 44484
Westerville, Ohio 43081
Wooster, Ohio 44691
Youngstown, Ohio 44501
Zanesville, Ohio 43701
Lawton, Oklahoma 73505
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877-231-4440
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73120
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405-752-3402
Baker City, Oregon 97814
Bend, Oregon 97701
Clackamas, Oregon 97015
Clackamas, Oregon 97015
Coos Bay, Oregon 97420
Newberg, Oregon 97132
Ontario, Oregon 97914
Oregon City, Oregon 97045
Portland, Oregon 97213
Portland, Oregon 97225
Redmond, Oregon 97756
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541-706-2909
Allentown, Pennsylvania 18103
Beaver, Pennsylvania 15009
Bethlehem, Pennsylvania 18017
Bryn Mawr, Pennsylvania 19010
Carlisle, Pennsylvania 17015
Chadds Ford, Pennsylvania 19317
Collegeville, Pennsylvania 19426
Danville, Pennsylvania 17822
East Stroudsburg, Pennsylvania 18301
Erie, Pennsylvania 16505
Exton, Pennsylvania 19341
Farrell, Pennsylvania 16121
Greensburg, Pennsylvania 15601
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724-838-1900
Harrisburg, Pennsylvania 17101
Harrisburg, Pennsylvania 17109
Hazleton, Pennsylvania 18201
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Hershey, Pennsylvania 17033-0850
Johnstown, Pennsylvania 15901
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814-534-4724
Lewisburg, Pennsylvania 17837
McKeesport, Pennsylvania 15132
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412-647-8073
Mechanicsburg, Pennsylvania 17050
Media, Pennsylvania 19063
Monroeville, Pennsylvania 15146
Moon, Pennsylvania 15108
Paoli, Pennsylvania 19301
Pittsburgh, Pennsylvania 15213
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412-647-2811
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412-784-4900
Pittsburgh, Pennsylvania 15232
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412-647-8073
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412-621-2334
Pittsburgh, Pennsylvania 15237
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412-502-3920
Pottsville, Pennsylvania 17901
Sayre, Pennsylvania 18840
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800-836-0388
Scranton, Pennsylvania 18510
Seneca, Pennsylvania 16346
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814-676-7900
Uniontown, Pennsylvania 15401
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724-437-2503
Washington, Pennsylvania 15301
Wilkes-Barre, Pennsylvania 18711
Wynnewood, Pennsylvania 19096
York, Pennsylvania 17408
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717-724-6760
Gaffney, South Carolina 29341
Greer, South Carolina 29651
Myrtle Beach, South Carolina 29577
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877-460-2657
Spartanburg, South Carolina 29303
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864-560-6812
Spartanburg, South Carolina 29303
Spartanburg, South Carolina 29307
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864-560-6812
Union, South Carolina 29379
Collierville, Tennessee 38017
Memphis, Tennessee 38120
Houston, Texas 77030
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713-792-3245
Humble, Texas 77338
Berlin, Vermont 05602
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802-225-5400
Burlington, Vermont 05401
Burlington, Vermont 05405
Saint Johnsbury, Vermont 05819
Charlottesville, Virginia 22908
Mechanicsville, Virginia 23116
Richmond, Virginia 23229
Richmond, Virginia 23235
Richmond, Virginia 23298
South Hill, Virginia 23970
Aberdeen, Washington 98520
Bellevue, Washington 98004
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425-454-2148
Bellingham, Washington 98225
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360-788-8223
Bremerton, Washington 98310
Centralia, Washington 98531
Edmonds, Washington 98026
Everett, Washington 98201
Issaquah, Washington 98029
Kennewick, Washington 99336
Kirkland, Washington 98034
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425-899-6000
Lacey, Washington 98503
Longview, Washington 98632
Port Townsend, Washington 98368
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360-344-3091
Renton, Washington 98055
Seattle, Washington 98107
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Seattle, Washington 98133
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206-606-5800
Sedro-Woolley, Washington 98284
Shelton, Washington 98584
Vancouver, Washington 98664
Walla Walla, Washington 99362
Yakima, Washington 98902
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Charleston, West Virginia 25304
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304-388-9944
Huntington, West Virginia 25701
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Antigo, Wisconsin 54409
Appleton, Wisconsin 54911
Ashland, Wisconsin 54806
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Burlington, Wisconsin 53105
Eau Claire, Wisconsin 54701
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Germantown, Wisconsin 53022
Grafton, Wisconsin 53024
Green Bay, Wisconsin 54301
Green Bay, Wisconsin 54303
Green Bay, Wisconsin 54311
Hayward, Wisconsin 54843
Kenosha, Wisconsin 53142
La Crosse, Wisconsin 54601
Madison, Wisconsin 53792
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800-622-8922
Marinette, Wisconsin 54143
Marshfield, Wisconsin 54449
Medford, Wisconsin 54451
Menomonee Falls, Wisconsin 53051
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262-257-5100
Milwaukee, Wisconsin 53209
Milwaukee, Wisconsin 53215
Milwaukee, Wisconsin 53226
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414-805-3666
Milwaukee, Wisconsin 53233
Minocqua, Wisconsin 54548
Mukwonago, Wisconsin 53149
New Richmond, Wisconsin 54017
Oak Creek, Wisconsin 53154
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414-805-0505
Oconomowoc, Wisconsin 53066
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262-928-7878
Oshkosh, Wisconsin 54904
Racine, Wisconsin 53406
Rice Lake, Wisconsin 54868
Sheboygan, Wisconsin 53081
Spooner, Wisconsin 54801
Stevens Point, Wisconsin 54481
Stevens Point, Wisconsin 54482
Sturgeon Bay, Wisconsin 54235-1495
Summit, Wisconsin 53066
Superior, Wisconsin 54880
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701-364-6272
Two Rivers, Wisconsin 54241
Waukesha, Wisconsin 53188
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262-928-7632
Waukesha, Wisconsin 53188
Wausau, Wisconsin 54401
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877-405-6866
Wauwatosa, Wisconsin 53226
West Allis, Wisconsin 53227
West Bend, Wisconsin 53095
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414-805-0505
Weston, Wisconsin 54476
Wisconsin Rapids, Wisconsin 54494
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715-422-7718
Cheyenne, Wyoming 82001
Cody, Wyoming 82414
Sheridan, Wyoming 82801
More Details
- NCT ID
- NCT04092283
- Status
- Recruiting
- Sponsor
- National Cancer Institute (NCI)
Detailed Description
PRIMARY OBJECTIVE: I. To evaluate whether there is an improvement in overall survival with concomitant chemotherapy/radiation therapy/MEDI4736 (durvalumab) followed by one year (12 cycles) of MEDI4736 (durvalumab) as compared to concomitant chemotherapy/radiation followed by one year (12 cycles) of MEDI4736 (durvalumab). SECONDARY OBJECTIVES: I. To evaluate the difference in response using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria to assess whether or not MEDI4736 (durvalumab) added to concomitant chemo/radiation results in an improvement in response rates. II. To evaluate any difference in progression free survival (PFS) with concomitant chemotherapy/radiation therapy/MEDI4736 (durvalumab) followed by one year (12 cycles) of MEDI4736 (durvalumab) as compared to concomitant chemotherapy/radiotherapy followed by one year of MEDI4736 (durvalumab). III. To evaluate whether the incidence of recurrence and recurrence pattern is affected by giving MEDI4736 (durvalumab) during chemo/radiation. IV. To evaluate any difference in toxicity when MEDI4736 (durvalumab) is added to concomitant chemo/radiation using the Common Terminology Criteria for Adverse Events (CTCAE). OUTLINE: STEP 1 (CONCURRENT THERAPY): Patients are randomized to 1 of 2 arms. ARM A: Patients receive durvalumab intravenously (IV) over 60 minutes on days 1 and 15 of cycle 1 and day 1 of cycle 2. Patients also receive 1 of 3 treatment regimens per investigator choice: 1) etoposide IV over 60 minutes on days 1-5 and cisplatin IV over 60 minutes on days 1 and 8 every 28 days for 2 cycles; 2) pemetrexed disodium IV over 60 minutes and cisplatin IV over 60-120 minutes on day 1 every 21 days for 2 cycles; or 3) paclitaxel IV over 60 minutes and carboplatin IV over 30 minutes on day 1 every 7 days for 6 cycles. Treatment continues in the absence of disease progression or unacceptable toxicity. Beginning on day 1 of chemotherapy, patients receive radiation therapy 5 days a week for 6 weeks. ARM B: Patients receive 1 of 3 investigator's choice treatment regimens and radiation therapy as in Arm A. STEP 2 (CONSOLIDATION THERAPY): Within 14 days after the last dose of radiation (from Step 1), all patients then receive durvalumab IV over 60 minutes on day 1. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months if less than 2 years from study entry, every 6 months if 2-5 years from study entry, and then yearly for years 5-10 from study entry.