AN OPEN-LABEL, RANDOMIZED PHASE 3 TRIAL OF NIVOLUMAB, OR NIVOLUMAB PLUS IPILIMUMAB, VERSUS PLATINUM DOUBLET CHEMOTHERAPY IN SUBJECTS WITH CHEMOTHERAPY-NAÏVE STAGE IV OR RECURRENT NON-SMALL CELL LUNG CANCER (NSCLC)

Not Applicable

• Conditions: -C349 Bronchus or lung, unspecified; Bronchus or lung, unspecified; C349

• Registration Number: PER-049-15
• Lead Sponsor: BRISTOL MYERS SQUIBB COMPANY,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-16
• Study Completion: 2016-11-30
• Last Update Posted: 20 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 5

Inclusion Criteria

ECOG Performance Status of 1.
•Patients with histologically confirmed Stage IV or recurrent NSCLC (per the 7th International Association for the Study of Lung Cancer classification squamous or nonsquamous histology, with no prior systemic anticancer therapy (including EGFR and ALK inhibitors) given as primary therapy for advanced or metastatic disease.
•Measurable disease by CT or MRI per RECIST 1.1 criteria.

Exclusion Criteria

Subjects with known EGFR mutations which are sensitive to available targeted inhibitor therapy.
•Subjects with known ALK translocations which are sensitive to available targeted inhibitor therapy.
•Subjects with untreated CNS metastases are excluded, even if asymptomatic.
•Subjects with an active, known or suspected autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not
requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are
permitted to enroll.
•Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topicalsteroids, and adrenal replacement steroid > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified