A Study to Test Combination Treatments in People With Advanced Non-Small Cell Lung Cancer

Phase 1

• 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-ES
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-31
• Last Update Posted: 6 February 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1380

Inclusion Criteria

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

Exclusion Criteria

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