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)
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
Arm:
- 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 |