An Open-Label, Randomized, Phase 3 Trial of Nivolumab versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer

• Conditions: Stage IV or Recurrent Non-Small Cell Lung Cancer; MedDRA version: 17.0Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 17.0Level: PTClassification code 10029515Term: Non-small cell lung cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-004502-93-RO
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-30
• Last Update Posted: 2 March 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1250

Inclusion Criteria

• ECOG PS = 1
• Histologically confirmed Stage IV, or Recurrent NSCLC with no prior systemic anticancer therapy
• Measurable disease by CT or MRI per RECIST 1.1 criteria
• PD-L1+ on immunohistochemistry testing performed by central lab
• Men and women, ages = 18 years of age

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 750
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 500

Exclusion Criteria

• Known EFGR mutations which are sensitive to available targeted inhibitor therapy
• Known ALK translocations
• Untreated CNS metastases
• Previous malignancies
• Active, known or suspected autoimmune disease

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified