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

Completed · Phase 3

Conditions studied: Non Small Cell Lung Cancer (NSCLC)

In brief

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.

Key facts

Study ID

NCT02066636

Run by

Bristol-Myers Squibb

People needed

1428

Starts

2014-04-09

Expected to finish

2021-10-06

Last updated by the study team

2022-10-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cancer Center Treatment Center of America — Goodyear, Arizona, United States
• Arizona Oncology Associates — Phoenix, Arizona, United States
• Arizona Oncology Associates — Sedona, Arizona, United States
• Arizona Oncol Assoc Dba (Hem Onc Physicians&Extenders) Hope — Tucson, Arizona, United States
• Comprehensive Blood And Cancer Center — Bakersfield, California, United States
• Diablo Valley Oncology — Concord, California, United States
• Saint Jude Heritage Medical Group Virginia K Crosson Cancer Center — Fullerton, California, United States
• Ucla Hema/Onc-Santa Monica — Los Angeles, California, United States
• Pacific Cancer Care — Monterey, California, United States
• Sutter Cancer Center — Sacramento, California, United States
• Local Institution — San Francisco, California, United States
• Central Coast Med Oncology — San Luis Obispo, California, United States
• Sansum Santa Barbara Medical Foundation Clinic — Santa Barbara, California, United States
• Central Coast Med Oncology — Santa Maria, California, United States
• Torrance Memorial Medical Center — Torrance, California, United States
• Rocky Mountain Cancer Centers — Denver, Colorado, United States
• Mountain Blue Cancer Care Center — Golden, Colorado, United States
• St. Mary's Hospital Regional Cancer Center — Grand Junction, Colorado, United States
• Eastern Ct Hem Onc Assoc — Norwich, Connecticut, United States
• Holy Cross Hospital Inc. — Fort Lauderdale, Florida, United States
• Florida Cancer Specialists S. — Fort Myers, Florida, United States
• Baptist Cancer Institute — Jacksonville, Florida, United States
• Local Institution - 0031 — Lakeland, Florida, United States
• Local Institution - 0038 — Miami, Florida, United States
• Southern Cancer Center Pc — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.