Description:
The purpose of this study is to show that Nivolumab will improve progression free survival in subjects with strongly Stage IV or Recurrent PD-L1+ non-small cell lung cancer when compared to chemotherapy
The purpose of this study is to show that Nivolumab will improve progression free survival in subjects with strongly Stage IV or Recurrent PD-L1+ non-small cell lung cancer when compared to chemotherapy
Active, not recruiting
Phase 3
NCT ID: NCT02041533
ORG ID: CA209-026
NCI ID: 2012-004502-93
Stage IV or Recurrent Non-Small Cell Lung Cancer
Drug | Synonyms | Arms |
---|---|---|
Gemcitabine | Gemzar | Arm B: Investigator's Choice Chemotherapy |
Cisplatin | Platinol | Arm B: Investigator's Choice Chemotherapy |
Carboplatin | Paraplatin | Arm B: Investigator's Choice Chemotherapy |
Paclitaxel | Taxol | Arm B: Investigator's Choice Chemotherapy |
Pemetrexed | Alimta | Arm B: Investigator's Choice Chemotherapy |
The purpose of this study is to show that Nivolumab will improve progression free survival
in subjects with strongly Stage IV or Recurrent PD-L1+ non-small cell lung cancer when
compared to chemotherapy
Name | Type | Description | Interventions |
---|---|---|---|
Arm A: Nivolumab subjects | Experimental | Nivolumab solution for Injection 3 mg/kg Intravenous every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure | |
Arm B: Investigator's Choice Chemotherapy | Active Comparator | Investigator's Choice Chemotherapy administered in 3-week cycles up to a maximum of 6 cycles of Intravenous injection until disease progression, unacceptable toxicity or completion of the 6 cycles, whichever comes first Squamous subjects: Gemcitabine 1250 mg/mg(2) administered on Day 1 and Day 8 with Cisplatin 75 mg/m(2) administered on Day 1 of each cycle; or Gemcitabine 1000 mg/mg(2) administered on Day 1 and Day 8 with Carboplatin (AUC 5) administered on Day 1 of each cycle; or Paclitaxel 200 mg/m(2) with Carboplatin (AUC 6) administered on Day 1 of each cycle Non-Squamous subjects: Pemetrexed 500 mg/m(2) with Cisplatin 75 mg/m(2) administered on Day 1 of each cycle Pemetrexed 500 mg/m(2) Carboplatin (AUC 6) administered on Day 1 of each cycle Optional crossover: Nivolumab solution for Injection 3 mg/kg Intravenous every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent or study closure | Gemcitabine, Cisplatin, Carboplatin, Paclitaxel, Pemetrexed |
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 1
- Histologically confirmed Stage IV, or Recurrent NSCLC with no prior systemic
anticancer therapy
- Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI)
per response evaluation criteria in solid tumors version (RECIST) 1.1 criteria
- PD-L1+ on immunohistochemistry testing performed by central lab
- Men and women, ages 18 years of age
Exclusion Criteria:
- Known epidermal growth factor receptor (EGFR) mutations which are sensitive to
available targeted inhibitor therapy
- Known anaplastic lymphoma kinase (ALK) translocations
- Untreated central nervous system (CNS) metastases
- Previous malignancies
- Active, known or suspected autoimmune disease
Minimum Eligible Age: 18 Years
Maximum Eligible Age: N/A
Eligible Gender: Both
Progression Free Survival (PFS) as assessed by independent radiology review committee (IRRC) in subjects with strongly Programmed death-ligand 1+ (PD-L1+) tumor expression
Objective response rate (ORR) as determined per IRRC in subjects with strongly PD-L1+ tumor expression
Overall survival (OS) in subjects with strongly PD-L1+ tumor expression
PFS in all subjects with any PD-L1+ tumor expression
Disease related symptom improvement in all subjects