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) (CheckMate 227)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: Paclitaxel; Drug: Nivolumab; Drug: Carboplatin; Drug: Pemetrexed; Drug: Cisplatin; Drug: Ipilimumab; Drug: Gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02477826

CA209-227

2014-003630-23 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 2,748 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

2,748 participants in 4 patient groups

Arm A: Nivolumab

Experimental group

Description:

Nivolumab intravenously (IV) as specified

Treatment:

Drug: Nivolumab

Arm B: Nivolumab + Ipilimumab

Experimental group

Description:

Nivolumab + Ipilimumab IV as specified

Treatment:

Drug: Ipilimumab

Drug: Nivolumab

Arm C: Nivolumab + Platinum doublet chemotherapy

Experimental group

Description:

Nivolumab + Platinum doublet chemotherapy (IV) dose as specified

Treatment:

Drug: Gemcitabine

Drug: Pemetrexed

Drug: Cisplatin

Drug: Carboplatin

Drug: Paclitaxel

Drug: Nivolumab

Arm D: Platinum doublet chemotherapy

Experimental group

Description:

Chemotherapy administered on specified days of IV chemotherapy

Treatment:

Drug: Gemcitabine

Drug: Pemetrexed

Drug: Cisplatin

Drug: Carboplatin

Drug: Paclitaxel