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

• Sponsor: Exosome Diagnostics, Inc. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03236675
• Collaborator: (none)
• Enrollment: 60
• Locations: 2
• Duration (Months): 83.1
• Patients Per Site: 30
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Non-Small-Cell Lung

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 Design

• Study Type: Observational
• Anticipated Enrollment: 60 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Detection of Either the EML4-ALK Gene Rearrangements or the T790M EGFR Mutation in the Plasma of Advanced NSCLC Patients
• Study Start Date: Mar 1, 2015
• Anticipated Primary Completion Date: Feb 1, 2022
• Anticipated Study Completion Date: Feb 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
EML4-ALK ALK positive patients
T790M EGFR T790M positive patients

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Healthcare System	Hollywood	Florida	United States	33021
2	Ochsner Medical Center	New Orleans	Louisiana	United States	70121

Sponsors and Collaborators

• Exosome Diagnostics, Inc.

Investigators

• Study Director: Roger Tun, Exosome Diagnostics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Exosome Diagnostics, Inc.
• ClinicalTrials.gov Identifier: NCT03236675
• Other Study ID Numbers: ECT2015-003A
• First Posted: Aug 2, 2017
• Last Update Posted: Sep 30, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Sep 30, 2021