A Study of Nivolumab and Ipilimumab in Untreated Patients With Stage 3 NSCLC That is Unable or Not Planned to be Removed by Surgery

• Status: Not yet recruiting
• Trial end date: 2024-04-12
• Target enrollment: 1400
• Participant gender: All

Summary

The primary purpose of the study is to compare the effectiveness of nivolumab + CCRT followed by nivolumab + ipilimumab (Arm A) vs CCRT followed by durvalumab (Arm C) in participants with untreated Locally Advanced Non-small Cell Lung Cancer

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

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Durvalumab; Ipilimumab; Nivolumab

Criteria

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status ≤1

• Locally advanced stage IIIA, IIIB, or IIIC (T1-2 N2-3 M0, T3 N1-3 M0, or T4 N0-3 M0) histologically-confirmed NSCLC, according to 8th TNM classification.

• Newly diagnosed and treatment-naïve, with no prior local or systemic anticancer therapy given as primary therapy for locally advanced disease.

Exclusion Criteria:

• Any condition including medical, emotional, psychiatric, or logistical that, in the opinion of the Investigator would preclude the patient from adhering to the protocol or would increase the risk associated with study participation.

• Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.

• Active infection requiring systemic therapy within 14 days prior to randomization.

• Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured,

• Participants with an active, known or suspected autoimmune disease or a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of randomization.

• History of organ or tissue transplant that requires systemic use of immune suppressive agents.

• Clinical evidence of hearing loss and prior thoracic radiotherapy.

Other protocol defined inclusion/exclusion criteria could apply