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-IT

Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary: Not available

Detailed Description: Not available

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<br>;Primary end point(s): Progression Free Survival (PFS) as assessed by independent radiology review committee (IRRC) in subjects with strongly Programmed death-ligand 1+ (PD-L1+) tumor expression ;Timepoint(s) of evaluation of this end point: Up to approximately 33 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1- Objective response rate (ORR) as determined per IRRC in subjects with strongly PD-L1+ tumor expression<br>2- PFS in all subjects with any PD-L1+ tumor expression<br>3- Overall survival (OS) in subjects with strongly PD-L1+ tumor expression <br>4- Disease related symptom improvement in all subjects;Timepoint(s) of evaluation of this end point: 1- up to approximately 33 months<br>2- up to approximately 33 months<br>3- at least 33 months<br>4- up to approximately 33 months

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