Detection of Either the EML4-ALK Gene Rearrangements or the T790M EGFR Mutation in the Plasma of Advanced NSCLC Patients

• Conditions: Carcinoma, Non-Small-Cell Lung

• Registration Number: NCT03236675
• Lead Sponsor: Exosome Diagnostics, Inc.

Brief Summary

Demonstrate feasibility of detection of EML4-ALK fusion transcripts and T790M EGFR mutation from exosomes in the circulation of Non-Small Cell Lung Cancer (NSCLS) patients.

Detailed Description

The goal of this study is two-fold: 1) Demonstrate feasibility of detection of EML4-ALK fusion transcripts in the circulation of NSCLC patients positive for ALK on tissue analysis, using an institutionally accepted assay; 2) Demonstrate feasibility of detection of T790M EGFR mutation in the circulation of NSCLC patients positive for T790M on tissue analysis, using an institutionally accepted assay.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2016-02-24
• Study First Submitted QC: 2017-07-28
• Study First Posted: 2017-08-02
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-29
• Last Update Posted: 2021-09-30
• Primary Completion: 2022-02
• Study Completion: 2022-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Participants must have histologically confirmed NSCLC, stage IIIB- IV, and have tested positive for the presence of EML4-ALK on tissue specimen, fresh or archived, using an institutionally accepted assay.
2. Age of 18 years or older.
3. Participants are being considered for ALK-directed therapy or have progressed on EGFR TKI treatment.
4. Participants must have hemoglobin > 10 mg/dL.
5. Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria

1. Hepatitis (all types) in patient's medical record
2. HIV documented in patient's medical record
3. Hemoglobin < 10 mg/dL
4. Less than 18 years of age
5. Histologically confirmed NSCLC Stage I-IIIA
6. Tested negative for the presence of EML4-ALK and T790M EGFR on tissue

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ALK mutation by tissue assay.	Two years	Patients found to be positive for ALK mutation by tissue assay. ALK fusions in samples will be considered binary - positive or negative/ not assessable. 2x2 table will be constructed to determine concordance with tissue testing.
T790M EGFR mutation by tissue assay	Two years	Patients found to be positive for T790M EGFR mutation by tissue assay. ALK fusions in samples will be considered binary - positive or negative/ not assessable. 2x2 table will be constructed to determine concordance with tissue testing.

Trial Locations

Locations (2)

Ochsner Medical Center; 🇺🇸 New Orleans, Louisiana, United States

Memorial Healthcare System; 🇺🇸 Hollywood, Florida, United States