NCT02178163

Comprehensive Genomic Analysis in Tissue Samples From Patients With Recurrent or Stage IV Non-small Cell Lung Cancer

A Study to Assess the Ability to Initiate Therapy in Advanced Non-small Cell Lung Cancer (NSCLC) Patients Based on Genomic Analyses of Tumor Specimens.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,020 (estimated)
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research trial studies comprehensive genomic analysis in tissue samples from patients with non-small cell lung cancer that has come back or is stage IV. Comprehensive genomic analysis may identify specific gene mutations (changes in deoxyribonucleic acid \[DNA\]) and help doctors to tailor treatment to target the specific mutations.

Detailed description

PRIMARY OBJECTIVES: I. To assess the percentage of advanced non-small cell lung cancer patients in whom therapy can be initiated based on genomic analysis of tumor specimens. SECONDARY OBJECTIVES: I. To estimate the percentage of patients in whom genomic analysis can be performed. II. To assess the progression free survival and response rate in patients who start therapy based on the genomic analyses results. OUTLINE: Patients undergo collection of tissue samples for genomic analysis via mass spectrometry, polymerase chain reaction (PCR), and microarray. Based on the results of the genomic analysis, patients may begin therapy. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then every 12 months thereafter.

Conditions

• Recurrent Non-small Cell Lung Cancer
• Stage IV Non-small Cell Lung Cancer

Interventions

Type	Name	Description
OTHER	cytology specimen collection procedure	Correlative studies
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2014-08-01
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2014-06-30
• Last updated: 2025-07-25

Locations

11 sites across 1 country: United States