CheckMate 816: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 816
Phase 3
Completed
- Conditions
- on-Small Cell Lung Cancer
- Registration Number
- JPRN-jRCT2080223597
- Lead Sponsor
- Bristol-Myers Squibb K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 642
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Event-Free Survival<br>Pathological Complete Response
- Secondary Outcome Measures
Name Time Method efficacy<br>Overall survival (OS)<br>Major pathological response (MPR)