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Clinical trial

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)

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Last updated:31st Jul 2015
Identifier: NCT02477826

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.

Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 2220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Randomized Phase 3 Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Subjects With Chemotherapy-Naïve Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)
Study Start Date: August 2015
Estimated Primary Completion Date: January 2019
Estimated Study Completion Date: December 2020

- Experimental:
Arm A: Nivolumab
- Experimental: Arm B: Nivolumab + Ipilimumab
- Experimental: Arm C: Nivolumab + Platinum doublet chemotherapy
- Active Comparator: Arm D: Platinum doublet chemotherapy

Category Value
Date last updated at source 2018-06-20
Study type(s) Interventional
Expected enrolment 2220
Study start date 2015-08-01
Estimated primary completion date 2019-01-01

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