Lung Cancer Clinical Trial
A Safety Trial of Nivolumab in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed During or After Receiving At Least One Prior Chemotherapy Regimen
Summary
The purpose of this study is to estimate the incidence and characterize the outcome of high grade, select adverse events in subjects with advanced or metastatic NSCLC treated with Nivolumab.
Eligibility Criteria
Inclusion Criteria:
1. Target Population
Subjects with histologically-or cytologically-documented NSCLC [squamous (SQ) or nonsquamous (NSQ)] who present with Stage IIIB/Stage IV disease (according to version 7 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology), or with recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection or definitive chemoradiotherapy for locally advanced disease)
Subjects must have experienced disease progression or recurrence during or after at least one systemic therapy for advanced or metastatic disease
Each subsequent line of therapy must be preceded by disease progression. A switch of an agent within a regimen in order to manage toxicity does not define the start of a new line of therapy
Maintenance therapy following platinum doublet-based chemotherapy is not considered as a separate regimen of therapy
Subjects who received platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, and developed recurrent (local or metastatic) disease within 6 months of completing therapy are eligible
Subjects with recurrent disease >6 months after platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, who also subsequently progressed during or after a platinum doublet-based regimen given to treat the recurrence are eligible
Subjects with non-squamous histology must be tested for Epithelial Growth Factor Receptor (EGFR) mutations (including, but not limited to, deletions in exon 19 and exon 21 [L858R] substitution) and Anaplastic Lymphoma Kinase (ALK) rearrangement if tests have not been previously performed. Subjects with progressive disease during or after EGFR or ALK tyrosine kinase inhibitor (TKI) regimens are eligible. Subjects are eligible if genetic test results are indeterminate or if no tumor tissue is available or accessible for testing as long as they have received one prior systemic therapy
Experimental therapies when given as separate regimen are considered as separate line of therapy
Subjects must have measurable disease by CT or MRI per RECIST 1.1 criteria (radiographic tumor assessment performed within 28 days of first dose of study drug) or clinically apparent disease that the investigator can follow for response per RECIST 1.1
Eastern Cooperative Oncology Arm (ECOG) performance status (PS)
PS 0 to 1
PS 2
Exclusion Criteria:
Target Disease Exceptions
Subjects with active central nervous system (CNS) metastases are excluded
Subjects with carcinomatous meningitis
Medical History and Concurrent Diseases
Subjects with a history of interstitial lung disease
Subjects with active, known or suspected autoimmune disease
Subject whom participated in either arm of the following clinical trials CA209-017, CA209-057, CA209-026, and CA184-104 or received prior treatment with anti-programmed death 1 (PD-1) or anti-programmed death-ligand 1 (PDL1) experimental agents
Prohibited Treatments and/or Restricted Therapies
Ongoing or planned administration of anti-cancer therapies other than those specified in this study
Use of corticosteroids or other immunosuppressive medications
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There are 131 Locations for this study
Mobile Alabama, 36608, United States
Goodyear Arizona, 85338, United States
Phoenix Arizona, 85016, United States
Sedona Arizona, 86336, United States
Tucson Arizona, 85704, United States
Bakersfield California, 93309, United States
Concord California, 94520, United States
Fullerton California, 92835, United States
Los Angeles California, 90095, United States
Monterey California, 93940, United States
Sacramento California, 95816, United States
San Francisco California, 94117, United States
San Luis Obispo California, 93401, United States
Santa Barbara California, 93105, United States
Santa Maria California, 93454, United States
Torrance California, 90505, United States
Denver Colorado, 80218, United States
Golden Colorado, 80401, United States
Grand Junction Colorado, 81501, United States
Norwich Connecticut, 06360, United States
Fort Lauderdale Florida, 33308, United States
Fort Myers Florida, 33901, United States
Jacksonville Florida, 32207, United States
Lakeland Florida, 33805, United States
Miami Florida, 33176, United States
Ocala Florida, 34474, United States
Orlando Florida, 32804, United States
Pemroke Pines Florida, 33028, United States
Pensacola Florida, 32504, United States
Port Saint Lucie Florida, 34952, United States
Saint Petersburg Florida, 33705, United States
Tampa Florida, 33612, United States
Titusville Florida, 32796, United States
Athens Georgia, 30607, United States
Atlanta Georgia, 30318, United States
Macon Georgia, 31201, United States
Newnan Georgia, 30265, United States
Savannah Georgia, 31405, United States
Thomasville Georgia, 31792, United States
Valdosta Georgia, 31602, United States
Chicago Illinois, 60612, United States
Niles Illinois, 60714, United States
Park Ridge Illinois, 60068, United States
Quincy Illinois, 62301, United States
Skokie Illinois, 60077, United States
Springfield Illinois, 62794, United States
Fort Wayne Indiana, 46804, United States
Indianapolis Indiana, 46202, United States
Wichita Kansas, 67214, United States
Louisville Kentucky, 40202, United States
Louisville Kentucky, 40202, United States
Paducah Kentucky, 42003, United States
Shreveport Louisiana, 71105, United States
Brewer Maine, 04412, United States
Annapolis Maryland, 21401, United States
Baltimore Maryland, 21204, United States
Bethesda Maryland, 20889, United States
Columbia Maryland, 21044, United States
Easton Maryland, 21601, United States
Ann Arbor Michigan, 48016, United States
Grand Rapids Michigan, 49503, United States
Southfield Michigan, 48075, United States
Hattiesburg Mississippi, 39401, United States
Jackson Mississippi, 39202, United States
Tupelo Mississippi, 38801, United States
North Kansas City Missouri, 64116, United States
Springfield Missouri, 65807, United States
Lincoln Nebraska, 68510, United States
Omaha Nebraska, 68130, United States
Las Vegas Nevada, 89119, United States
Reno Nevada, 89502, United States
Flemington New Jersey, 08822, United States
Summit New Jersey, 07091, United States
Albuquerque New Mexico, 87110, United States
Albany New York, 12208, United States
Brooklyn New York, 11220, United States
Fresh Meadows New York, 11366, United States
Johnson City New York, 13790, United States
Mineola New York, 11501, United States
Mount Kisco New York, 10549, United States
New York New York, 10032, United States
Nyack New York, 10960, United States
Asheboro North Carolina, 27203, United States
Goldsboro North Carolina, 27534, United States
Greensboro North Carolina, 27403, United States
Greeville North Carolina, 27834, United States
Salisbury North Carolina, 28144, United States
Bismarck North Dakota, 58501, United States
Cincinnati Ohio, 45242, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43219, United States
Allentown Pennsylvania, 18103, United States
Bethlehem Pennsylvania, 18015, United States
Lancaster Pennsylvania, 17604, United States
Langhorne Pennsylvania, 19047, United States
Pittsburgh Pennsylvania, 15212, United States
Charleston South Carolina, 29414, United States
Columbia South Carolina, 29210, United States
Greenville South Carolina, 29605, United States
Chattanooga Tennessee, 37404, United States
Germantown Tennessee, 38138, United States
Germantown Tennessee, 38138, United States
Germantown Tennessee, 38138, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37232, United States
Abilene Texas, 79606, United States
Amarillo Texas, 79106, United States
Arlington Texas, 76012, United States
Beaumont Texas, 77702, United States
Bedford Texas, 76022, United States
Dallas Texas, 75230, United States
Dallas Texas, 75231, United States
Dallas Texas, 75246, United States
Denton Texas, 76201, United States
Fort Worth Texas, 76104, United States
Houston Texas, 77090, United States
McAllen Texas, 78503, United States
Mesquite Texas, 75150, United States
Midland Texas, 79701, United States
Plano Texas, 75075, United States
San Antonio Texas, 78212, United States
Sherman Texas, 75090, United States
Waco Texas, 76712, United States
Salt Lake City Utah, 84106, United States
Salt Lake City Utah, 84112, United States
Charlottesville Virginia, 22908, United States
Winchester Virginia, 22601, United States
Calgary Alberta, T2N 4, Canada
Halifax Nova Scotia, B3H 2, Canada
Kingston Ontario, K7L 2, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M5G 2, Canada
Levis Quebec, G6V 3, Canada
Montreal Quebec, H3T 1, Canada
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