Nivolumab in Combination With Ipilimumab (Part 1); Nivolumab Plus Ipilimumab in Combination With Chemotherapy (Part 2) as First Line Therapy in Stage IV Non-Small Cell Lung Cancer

• Status: Active, not recruiting
• Trial end date: 2022-04-20
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of part 1 of this study is to determine the objective response rate (ORR) in stage IV NSCLC subjects treated with nivolumab in combination with ipilimumab as first line therapy.

The purpose of part 2 of this study is to determine the safety and tolerability of nivolumab and ipilimumab combined with a short course of chemotherapy in first line stage IV NSCLC.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Antibodies, Monoclonal; Carboplatin; Cisplatin; Ipilimumab; Nivolumab; Paclitaxel; Pemetrexed

Criteria

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

Inclusion Criteria:

• Men and Women ≥ 18 years of age

• Diagnosed with stage IV Non-Small Cell Lung Cancer

• Diagnosed with recurrent stage IIIB non-small cell lung cancer and failed previous concurrent chemoradiation with no further curative options.

Exclusion Criteria:

• Subjects with untreated CNS metastases are excluded.

• Subjects with carcinomatous meningitis

• Subjects with an active, known or suspected autoimmune disease.

• Subjects with a condition requiring systemic treatment with either corticosteroids ( > 10 mg daily prednisone

equivalent) or other immunosuppressive medications within 14 days of first treatment.

• Women who are pregnant, plan to become pregnant, and/or breastfeed during the study.

Other protocol defined inclusion/exclusion criteria could apply