A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC)

• Status: Active, not recruiting
• Trial end date: 2028-11-08
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborator: Ono Pharmaceutical Co. Ltd
• Treatments: Antibodies, Monoclonal; Carboplatin; Docetaxel; Gemcitabine; Ipilimumab; Nivolumab; Paclitaxel; Pemetrexed; Vinorelbine

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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 could apply