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.
Recruiting
Phase 3
| Drug | Synonyms | Arms |
|---|---|---|
| Nivolumab | Opdivo | Arm A: Nivolumab |
| Ipilimumab | Yervoy | Arm B: Nivolumab + Ipilimumab |
| Carboplatin | Arm C: Nivolumab + Platinum doublet chemotherapy | |
| Cisplatin | Arm C: Nivolumab + Platinum doublet chemotherapy | |
| Gemcitabine | Arm C: Nivolumab + Platinum doublet chemotherapy | |
| Pemetrexed | Arm C: Nivolumab + Platinum doublet chemotherapy | |
| Paclitaxel | Arm C: Nivolumab + Platinum doublet chemotherapy |
| Name | Type | Description | Interventions |
|---|---|---|---|
| Arm A: Nivolumab | Experimental | Nivolumab intravenously (IV) as specified |
|
| Arm B: Nivolumab + Ipilimumab | Experimental | Nivolumab + Ipilimumab IV as specified |
|
| Arm C: Nivolumab + Platinum doublet chemotherapy | Experimental | Nivolumab + Platinum doublet chemotherapy (IV) dose as specified |
|
| Arm D: Platinum doublet chemotherapy | Experimental | Chemotherapy administered on specified days of IV chemotherapy |
|
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com
Inclusion Criteria:
- 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
Exclusion 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 could apply
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
| Measure: | Overall survival (OS) |
| Time Frame: | approximately 48 months |
| Safety Issue: | |
| Description: |
| Measure: | Objective response rate (ORR) |
| Time Frame: | Up to 48 months |
| Safety Issue: | |
| Description: | ORR of nivolumab monotherapy and nivolumab in combination with ipilimumab to platinum-doublet chemotherapy in subjects with advanced lung cancer |
| Measure: | Disease related symptom improvement as measured by the Lung Cancer Symptom Score (LCSS) in all subjects |
| Time Frame: | Up to 48 months |
| Safety Issue: | |
| Description: | Disease related symptom improvement assessed at each dosing for 6 months, then every 6 weeks while on treatment |
| Phase: | Phase 3 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Bristol-Myers Squibb |
March 23, 2021
