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: 16.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 16.1Level: 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-ES
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-18
• Last Update Posted: 12 May 2014

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The purpose of this study is to show that nivolumab will improve progression free survival in subjects with strongly PD-L1+ Stage IV or Recurrent non-small cell lung cancer when compared to chemotherapy.;Secondary Objective: ? ORR in subjects with strongly PD-L1+ tumor expression<br>? PFS in subjects with any PD-L1+ tumor expression<br>? OS in subjects with strongly PD-L1+ tumor expression<br>? Disease related symptom improvement;Primary end point(s): PFS in subjects with strongly PD-L1+ tumor expression;Timepoint(s) of evaluation of this end point: Progression Free Survival: Tumor assessments are scheduled every 6 weeks on-study until week 48, then every 12 weeks until progression.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): ? ORR in subjects with strongly PD-L1+ tumor expression<br>? PFS in subjects with any PD-L1+ tumor expression<br>? OS in subjects with strongly PD-L1+ tumor expression<br>? Disease related symptom improvement;Timepoint(s) of evaluation of this end point: ? ORR in subjects with strongly PD-L1+ tumor expression: Baseline, every 6 weeks until Week 48, then every 12 weeks until documented disease progression.<br>? PFS in subjects with any PD-L1+ tumor expression: Baseline, every 6 weeks until Week 48, then every 12 weeks until documented disease progression.<br>? OS in subjects with strongly PD-L1+ tumor expression: all subjects are followed for survival status every 3 months during follow-up phase. <br>? Disease related symptom improvement: assessed at each dosing for 6 months, then every 6 weeks while on treatment.