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
- 2748
- 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 (PFS) as determined by blinded independent central review (BICR) approximately 40 months Overall survival (OS) approximately 48 months
- Secondary Outcome Measures
Name Time Method Disease related symptom improvement as measured by the Lung Cancer Symptom Score (LCSS) in all subjects Up to 48 months Disease related symptom improvement assessed at each dosing for 6 months, then every 6 weeks while on treatment
Objective response rate (ORR) Up to 48 months ORR of nivolumab monotherapy and nivolumab in combination with ipilimumab to platinum-doublet chemotherapy in subjects with advanced lung cancer
Trial Locations
- Locations (290)
Local Institution - 0017
🇺🇸San Francisco, California, United States
Local Institution - 0115
🇺🇸Saint Louis, Missouri, United States
Local Institution - 0014
🇺🇸Cleveland, Ohio, United States
Local Institution - 0075
🇺🇸Langhorne, Pennsylvania, United States
Local Institution - 0083
🇮🇹Milan, Lombardia, Italy
Local Institution - 0179
🇮🇹Bergamo, Italy
Local Institution - 0087
🇮🇹Perugia, Italy
Local Institution - 0085
🇮🇹Terni, Italy
Southern Cancer Center, Inc.
🇺🇸Mobile, Alabama, United States
Local Institution - 0021
🇺🇸New Haven, Connecticut, United States
Scroll for more (280 remaining)Local Institution - 0017🇺🇸San Francisco, California, United States