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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) logo

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

Trial contacts and locations

291

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Data sourced from clinicaltrials.gov

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