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Closed (no longer recruiting)Last updated: 21 December 2023

CheckMate 227: This phase III trial is comparing the effectiveness of Nivolumab in combination with other therapies (Ipilimumab, platinum-doublet chemotherapy and another chemotherapy) for the treatment of advanced Lung CancerAn Open-Label, Randomized Phase 3 Trial of Nivolumab, or Nivolumab Plus Ipilimumab, Versus Platinum Doublet Chemotherapy in Subjects With Chemotherapy-Naive Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)

Clinical summary

Summary

The purpose of this study is to show that Nivolumab or Nivolumab plus ipilimumab, improves progression free survival and/or overall survival compared with chemotherapy in subjects advanced lung cancer. **Patients must have programmed death-ligand 1 (PD-L1) immunohistochemical (IHC) testing, with results, performed by the central lab during the Screening period**

Conditions

This trial is treating patients with Non-Small Cell Lung Cancer.

Cancer

Lung Cancers Lung cancer

Age

People18 - 75

Phase

III

Trial Acronym

CheckMate 227

More information

Trial Identifiers

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Trial sponsor

Bristol-Myers Squibb (BMS)

Scientific Title

An Open-Label, Randomized Phase 3 Trial of Nivolumab, or Nivolumab Plus Ipilimumab, Versus Platinum Doublet Chemotherapy in Subjects With Chemotherapy-Naive Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)

Eligibility

Inclusion

  • 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

  • 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

Inclusion

  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

RAP

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