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

BRAF, KRAS and EGFR Mutation Detection in Non-Small Cell Lung Cancer Patients Treated With Sorafenib Monotherapy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01124669
Enrollment
80
Registered
2010-05-17
Start date
2010-06-13
Completion date
2010-07-13
Last updated
2017-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

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.

Interventions

GENETICDNA analysis
GENETICmutation analysis
OTHERlaboratory biomarker analysis

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
ECOG-ACRIN Cancer Research Group
Lead SponsorNETWORK

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * Diagnosis of refractory non-small cell lung cancer * Received sorafenib tosylate on protocol ECOG-E2501 * Available blood specimens PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Design outcomes

Primary

MeasureTime frame
Mutation rate of sorafenib tosylate-target gene BRAF, and its upstream proteins KRAS and EGFR1 mont
Association between BRAF, KRAS, and EGFR mutation status and clinical benefits (stable disease or partial response)1 month

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026