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
Phase 1
- Conditions
- Stage IV or Recurrent Non-Small Cell Lung CancerMedDRA version: 20.0 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10029515 Term: Non-small cell lung cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-004502-93-GB
- 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
- Not specified
- Target Recruitment
- 1571
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 943
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 628
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. ;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 28 months ;<br> Secondary Objective: • PFS in subjects with any PD-L1+ tumor expression<br> • ORR in subjects with strongly PD-L1+ tumor expression<br> • OS in subjects with strongly PD-L1+ tumor expression<br> • Disease related symptom improvement<br>
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): 1- PFS in all subjects with any PD-L1+ tumor expression<br> 2- Objective response rate (ORR) as determined per IRRC in subjects with strongly 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<br> ;<br> Timepoint(s) of evaluation of this end point: 1- up to approximately 28 months<br> 2- up to approximately 28 months<br> 3- at least 28 months<br> 4- up to approximately 28 months<br>