A Study of Nivolumab in Advanced Non-Small Cell Lung Cancer (NSCLC)
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT02574078
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to determine whether nivolumab monotherapy or in combination with Standard of care (SOC) therapies will provide clinical benefit (i.e., PFS, OS, and DOR) without unacceptable toxicity in advanced Non-Small Cell Lung Cancer patients.
- Detailed Description
Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK)
\*\*Please note that the study is no longer enrolling patients for Groups A, B, C, and E.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 341
- Histologically confirmed locally advanced or stage IV NSCLC
- Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2
- Tumor tissue sections must be available for biomarker evaluation
- Untreated or active/progressing Central Nervous system (CNS) metastases
- Active, known or suspected autoimmune disease
- Known history of testing positive for HIV or AIDS
- Active or chronic infection of hepatitis B virus or hepatitis C
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A SOC maintenance therapy Bevacizumab Bevacizumab specified dose on specified days Pemetrexed specified dose on specified days Group A Nivolumab Nivolumab Opdivo specified dose on specified days Group A Nivolumab + SOC maintenance therapy Nivolumab Opdivo/Bevacizumab specified dose on specified days Opdivo/Pemetrexed specified dose on specified days Group A Nivolumab + SOC maintenance therapy Bevacizumab Opdivo/Bevacizumab specified dose on specified days Opdivo/Pemetrexed specified dose on specified days Group E Nivolumab + Crizotinib Crizotinib Opdivo/Crizotinib specified dose on specified days Group A SOC maintenance therapy Pemetrexed Bevacizumab specified dose on specified days Pemetrexed specified dose on specified days Group B Nivolumab Nivolumab Opdivo specified dose on specified days Group B Best supportive care Best Supportive Care Therapy directed against specific symptoms of disease, i.e., palliative radiation or palliative surgery Group A Nivolumab + SOC maintenance therapy Pemetrexed Opdivo/Bevacizumab specified dose on specified days Opdivo/Pemetrexed specified dose on specified days Group C Investigator's choice chemotherapy nab-Paclitaxel Carboplatin/nab-paclitaxel specified dose on specified days Carboplatin/paclitaxel specified dose on specified days Carboplatin/pemetrexed specified dose on specified days Carboplatin/docetaxel specified dose on specified days Carboplatin/gemcitabine specified dose on specified days Paclitaxel specified dose on specified days Docetaxel specified dose on specified days Gemcitabine specified dose on specified days Pemetrexed specified dose on specified days Group C Investigator's choice chemotherapy Carboplatin Carboplatin/nab-paclitaxel specified dose on specified days Carboplatin/paclitaxel specified dose on specified days Carboplatin/pemetrexed specified dose on specified days Carboplatin/docetaxel specified dose on specified days Carboplatin/gemcitabine specified dose on specified days Paclitaxel specified dose on specified days Docetaxel specified dose on specified days Gemcitabine specified dose on specified days Pemetrexed specified dose on specified days Group D Nivolumab + Erlotinib Nivolumab Opdivo/Erlotnib specified dose on specified days Group D Erlotinib Erlotinib Erlotinib specified dose on specified days Group C Investigator's choice chemotherapy Pemetrexed Carboplatin/nab-paclitaxel specified dose on specified days Carboplatin/paclitaxel specified dose on specified days Carboplatin/pemetrexed specified dose on specified days Carboplatin/docetaxel specified dose on specified days Carboplatin/gemcitabine specified dose on specified days Paclitaxel specified dose on specified days Docetaxel specified dose on specified days Gemcitabine specified dose on specified days Pemetrexed specified dose on specified days Group C Investigator's choice chemotherapy Paclitaxel Carboplatin/nab-paclitaxel specified dose on specified days Carboplatin/paclitaxel specified dose on specified days Carboplatin/pemetrexed specified dose on specified days Carboplatin/docetaxel specified dose on specified days Carboplatin/gemcitabine specified dose on specified days Paclitaxel specified dose on specified days Docetaxel specified dose on specified days Gemcitabine specified dose on specified days Pemetrexed specified dose on specified days Group C Investigator's choice chemotherapy Docetaxel Carboplatin/nab-paclitaxel specified dose on specified days Carboplatin/paclitaxel specified dose on specified days Carboplatin/pemetrexed specified dose on specified days Carboplatin/docetaxel specified dose on specified days Carboplatin/gemcitabine specified dose on specified days Paclitaxel specified dose on specified days Docetaxel specified dose on specified days Gemcitabine specified dose on specified days Pemetrexed specified dose on specified days Group C Investigator's choice chemotherapy Gemcitabine Carboplatin/nab-paclitaxel specified dose on specified days Carboplatin/paclitaxel specified dose on specified days Carboplatin/pemetrexed specified dose on specified days Carboplatin/docetaxel specified dose on specified days Carboplatin/gemcitabine specified dose on specified days Paclitaxel specified dose on specified days Docetaxel specified dose on specified days Gemcitabine specified dose on specified days Pemetrexed specified dose on specified days Group C Nivolumb Nivolumab Opdivo specified dose on specified days Group D Nivolumab + Erlotinib Erlotinib Opdivo/Erlotnib specified dose on specified days Group E Nivolumab + Crizotinib Nivolumab Opdivo/Crizotinib specified dose on specified days
- Primary Outcome Measures
Name Time Method Overall Survival (OS), Groups A-C Only up to approximately 60 months Overall survival (OS) is defined as the time from randomization to the date of death.
Percentage of Participants With Treatment-related Adverse Events (AEs) Leading to Both Study Drugs Discontinuation, Group E Only up to approximately 60 months Percentage of participants who experienced a treatment-related AE during the course of the study that lead to discontinuation of both study drugs.
Progression-Free Survival (PFS), Groups A-D Only up to approximately 48 months Progression-free survival (PFS) is defined as the time from randomization to the date of the first documented tumor progression, as determined by investigators (per RECIST v1.1), or death due to any cause, whichever occurs first.
- Secondary Outcome Measures
Name Time Method Progression-Free Survival (PFS), Group E Only up to approximately 48 months Progression-free survival (PFS) is defined as the time from randomization to the date of the first documented tumor progression, as determined by investigators (per RECIST v1.1), or death due to any cause, whichever occurs first.
Duration of Response (DOR), Groups A-D Only up to approximately 48 months Duration of response (DOR) is defined as the time from first confirmed response (complete response (CR) or partial response (PR)) to the date of the initial objectively documented tumor progression as determined using RECIST 1.1 criteria or death due to any cause, whichever occurs first.
Median computed using Kaplan-Meier method.Objective Response Rate (ORR), Groups A-E up to approximately 48 months Objective response rate (ORR) is defined as the number and percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR). Best overall response (BOR) is defined as the best response designation, recorded between the date of first dose and the date of the initial objectively documented tumor progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first.
Confidence interval based on the Clopper and Pearson method.Overall Survival (OS), Group D Only up to approximately 60 months Overall survival (OS) is defined as the time from randomization to the date of death.
Trial Locations
- Locations (122)
Alabama Oncology
🇺🇸Birmingham, Alabama, United States
Southern Cancer Center Pc
🇺🇸Mobile, Alabama, United States
Arizona Oncology Assoc, Pc-Hal
🇺🇸Glendale, Arizona, United States
Northern Arizona Hematology & Oncology Associates
🇺🇸Sedona, Arizona, United States
Arizona Oncol Assoc Dba (Hem Onc Physicians&Extenders) Hope
🇺🇸Tucson, Arizona, United States
Arizona Clinical Research Center, Inc.
🇺🇸Tucson, Arizona, United States
Comprehensive Blood And Cancer Center
🇺🇸Bakersfield, California, United States
St. Joseph Heritage Medical Group
🇺🇸Fullerton, California, United States
Scripps Cancer Center
🇺🇸La Jolla, California, United States
UCLA Hematology/Oncology Clinic
🇺🇸Los Angeles, California, United States
Scroll for more (112 remaining)Alabama Oncology🇺🇸Birmingham, Alabama, United States