An Investigational Immuno-therapy Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum-doublet Chemotherapy, Compared to Platinum Doublet Chemotherapy in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT02477826
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to show that Nivolumab, or Nivolumab plus Ipilimumab, or Nivolumab plus Platinum-Doublet Chemotherapy improves progression free survival and/or overall survival compared with chemotherapy in patients with advanced lung cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2747
- Subjects with histologically confirmed Stage IV or recurrent NSCLC squamous or non-squamous histology, with no prior systemic anticancer therapy
- Subjects must have programmed death-ligand 1 (PD -L1) immunohistochemical (IHC) testing, with results, performed by the central lab during the Screening period
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
- Measurable disease by CT or MRI per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) criteria
- Subjects with untreated Central nervous system (CNS) metastases are excluded
- Subjects with an active, known or suspected autoimmune disease are excluded
- Any positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) indicating acute or chronic infection
Other protocol defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B: Nivolumab + Ipilimumab Ipilimumab Nivolumab + Ipilimumab IV as specified Arm D: Platinum doublet chemotherapy Gemcitabine Chemotherapy administered on specified days of IV chemotherapy Arm D: Platinum doublet chemotherapy Paclitaxel Chemotherapy administered on specified days of IV chemotherapy Arm A: Nivolumab Nivolumab Nivolumab intravenously (IV) as specified Arm C: Nivolumab + Platinum doublet chemotherapy Nivolumab Nivolumab + Platinum doublet chemotherapy (IV) dose as specified Arm D: Platinum doublet chemotherapy Carboplatin Chemotherapy administered on specified days of IV chemotherapy Arm D: Platinum doublet chemotherapy Pemetrexed Chemotherapy administered on specified days of IV chemotherapy Arm C: Nivolumab + Platinum doublet chemotherapy Paclitaxel Nivolumab + Platinum doublet chemotherapy (IV) dose as specified Arm B: Nivolumab + Ipilimumab Nivolumab Nivolumab + Ipilimumab IV as specified Arm C: Nivolumab + Platinum doublet chemotherapy Cisplatin Nivolumab + Platinum doublet chemotherapy (IV) dose as specified Arm C: Nivolumab + Platinum doublet chemotherapy Carboplatin Nivolumab + Platinum doublet chemotherapy (IV) dose as specified Arm C: Nivolumab + Platinum doublet chemotherapy Gemcitabine Nivolumab + Platinum doublet chemotherapy (IV) dose as specified Arm C: Nivolumab + Platinum doublet chemotherapy Pemetrexed Nivolumab + Platinum doublet chemotherapy (IV) dose as specified Arm D: Platinum doublet chemotherapy Cisplatin Chemotherapy administered on specified days of IV chemotherapy
- Primary Outcome Measures
Name Time Method Progression-Free Survival Per BICR From randomization untill disease progression or death, whichever occurs first (up to approximately 481 weeks) Progression-Free Survival then (PFS) is defined as the time between the date of randomization and the date of first documented disease progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first based on Kaplan-Meier estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Overall Survival From randomization untill death or last follow up whichever occurs first (up to approximately 481 weeks) OS for all randomized participants is the time between randomization date and the date of death from any cause.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Symptom Deterioration at Week 12 Assessed Via Lung Cancer Symptom Scale Week 12 The Lung Cancer Symptom Scale (LCSS) is a disease measure of quality of life which evaluates six major lung cancer symptoms and their effect on overall distress and symptom severity, impact on day-to-day activities, and overall quality of life. This patient reported outcome (PRO) questionnaire assesses the following 6 symptoms items (appetite loss, fatigue, cough, dyspnea, hemoptysis, pain) and 3 summary global items (symptom distress, activity level, overall quality of life) for patients using visual analogue scales (VAS) (100 mm horizontal line) ranging from 0 (best rating) to 100 (worst rating). The LCSS average total score is sum of items 1 to 9 divided by the total number of items ((sum of items 1 to 9)/9) ranging from 0 to 100 where high score represent worst outcome. Disease-Related Symptom Deterioration by Week 12 defined as a 10 points or more increase from baseline in LCSS average score at any time (on or off-treatment) up to 95 days from randomization date.
Objective Response Rate (ORR) Per BICR From randomization untill disease progression or death, whichever occurs first (up to approximately 481 weeks) Objective response rate (ORR) is defined as the number of participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on blinded independent central review (BICR) assessments using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), divided by the number of all randomized participants.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Trial Locations
- Locations (290)
Southern Cancer Center, Inc.
🇺🇸Mobile, Alabama, United States
Local Institution - 0017
🇺🇸San Francisco, California, United States
Local Institution - 0021
🇺🇸New Haven, Connecticut, United States
Local Institution - 0001
🇺🇸Atlanta, Georgia, United States
Local Institution - 0013
🇺🇸Marietta, Georgia, United States
Local Institution - 0004
🇺🇸Lexington, Kentucky, United States
Local Institution - 0115
🇺🇸St Louis, Missouri, United States
Local Institution - 0005
🇺🇸Buffalo, New York, United States
Local Institution - 0019
🇺🇸New York, New York, United States
Local Institution - 0014
🇺🇸Cleveland, Ohio, United States
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