A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC)
Purpose
The purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus ipilimumab's safety and effectiveness in treating resectable NSCLC. This study has multiple primary endpoints.
Condition
- Non Small Cell Lung Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Early stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue - Lung function capacity capable of tolerating the proposed lung surgery - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 - Available tissue of primary lung tumor
Exclusion Criteria
- Presence of locally advanced, inoperable or metastatic disease - Participants with active, known or suspected autoimmune disease - Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors) Other protocol defined inclusion/exclusion criteria apply
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Active Comparator Platinum doublet chemotherapy |
Specified dose on specified days |
|
Experimental Nivolumab plus platinum doublet chemotherapy |
Specified dose on specified days |
|
Experimental Nivolumab plus Ipilimumab |
Specified dose on specified days |
|
Recruiting Locations
More Details
- NCT ID
- NCT02998528
- Status
- Active, not recruiting
- Sponsor
- Bristol-Myers Squibb