Biomarkers in Blood Samples From Patients With Refractory Non-Small Cell Lung Cancer Previously Treated With Sorafenib Tosylate

Completed

• Conditions: Lung Cancer

• Registration Number: NCT01124669
• Lead Sponsor: ECOG-ACRIN Cancer Research Group

Brief Summary

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in blood samples from patients with refractory non-small cell lung cancer previously treated with sorafenib tosylate.

Detailed Description

OBJECTIVES:

* To determine the mutation rates of BRAF, KRAS, and EGFR in patients with non-small cell lung cancer treated with sorafenib tosylate on protocol ECOG-2501.

* To determine the association between BRAF, KRAS, or EGFR mutation status and clinical benefits in patients treated with this regimen.

OUTLINE: This is a multicenter study.

DNA is isolated from archived plasma samples and analyzed for BRAF, KRAS, and EGFR mutations.

Study Timeline

• Study First Submitted: 2010-05-14
• Study First Submitted QC: 2010-05-14
• Study First Posted: 2010-05-17
• Study Start: 2010-06-13
• Primary Completion: 2010-07-13
• Study Completion: 2010-07-13
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-16
• Last Update Posted: 2017-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Association between BRAF, KRAS, and EGFR mutation status and clinical benefits (stable disease or partial response)	1 month
Mutation rate of sorafenib tosylate-target gene BRAF, and its upstream proteins KRAS and EGFR	1 mont