Clinical Trial: NCT02477826
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)
Status:
COMPLETEDPhase:
Phase 3| Lead Sponsor: | Bristol-Myers Squibb |
| Information Provided By: | Bristol-Myers Squibb |
| Last Update Posted: | 2025-10-30 |
Study Overview
Brief Summary
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.
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)
Conditions
Non-Small Cell Lung Cancer
Intervention / Treatment
- Drug: Nivolumab
- Drug: Ipilimumab
- Drug: Carboplatin
- Drug: Cisplatin
- Drug: Gemcitabine
- Drug: Pemetrexed
- Drug: Paclitaxel
Other Study ID Numbers
- CA209-227
- 2014-003630-23
- 2014
Start Date (Actual)
2015-08-05
Primary Completion Date (Actual)
2024-10-25
Study Completion Date (Actual)
2024-10-25
Enrollment (Actual)
2747
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Bristol-Myers Squibb |
| Information Provided By: | Bristol-Myers Squibb |
| Last Update Posted: | 2025-10-30 |
Study Overview
Brief Summary
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.
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)
Conditions
Non-Small Cell Lung Cancer
Intervention / Treatment
- Drug: Nivolumab
- Drug: Ipilimumab
- Drug: Carboplatin
- Drug: Cisplatin
- Drug: Gemcitabine
- Drug: Pemetrexed
- Drug: Paclitaxel
Other Study ID Numbers
- CA209-227
- 2014-003630-23
- 2014
Start Date (Actual)
2015-08-05
Primary Completion Date (Actual)
2024-10-25
Study Completion Date (Actual)
2024-10-25
Enrollment (Actual)
2747
Study Type
Interventional
Phase
Phase 3