MedPath

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: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 21.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]
Registration Number
EUCTR2016-001835-11-IT
Lead Sponsor
BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
295
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 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 450

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
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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