A Study to Test Combination Treatments in People With Advanced Non-Small Cell Lung Cancer
- Conditions
- Advanced Non-Small Cell Lung Cancer (NSCLC)MedDRA version: 19.0Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-001835-11-FR
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 295
For the master Protocol :
-Advanced Non Small Cell Lung Cancer (NSCLC)
-ECOG Performance status of = 1
-Life expectancy of at least 3 months from most recent chemotherapy or immunotherapy treatment
-Must have at least 1 lesion with measurable disease
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 552
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 828
For the master Protocol :
-Subjects with certain mutations must have been treated with a targeted therapy prior to enrollment
-Must not have suspected or known central nervous system metastases unless adequately treated
-Subjects who need daily oxygen therapy
-People with 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 determine whether nivolumab in combination with other therapies is more effective than nivolumab alone in people with advanced lung cancer.;Secondary Objective: To investigate additional safety and tolerability of each FRACTION-Lung treatment combination in subjects with NSCLC;Primary end point(s): To Assess the efficacy (objective response rate [ORR]), duration of response [DOR], and progression-free survival rate [PFSR];Timepoint(s) of evaluation of this end point: 24 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): To investigate additional safety and tolerability of each FRACTIONLung Treatment combination based on incidence of adverse events, serious adverse events, adverse events leading to discontinuation and deaths;Timepoint(s) of evaluation of this end point: 24 weeks + 100 days