A Prospective Study of Plasma Genotyping as a Noninvasive Biomarker for Genotype-directed Cancer Care

Running, not enrolling

Conditions studied: NSCLC, Melanoma

In brief

Tumor genotyping has become an essential biomarker for the care of advanced lung cancer and melanoma, and is currently used to identify patients for treatment with targeted kinase inhibitors like erlotinib and vemurafenib. However, tumor genotyping can be slow and cumbersome, and is limited by availability of tumor biopsy tissue for testing. The aim of this study is to prospectively evaluate a blood-based genotyping tool that can quantify the presence of oncogenic mutations (EGFR, KRAS, BRAF) in patients with lung cancer and melanoma. This assay is being studied both as a diagnostic tool for classifying patient genotype, and a serial measurement tool for quantification of response and progression on therapy.

Key facts

Study ID

NCT02279004

Run by

Dana-Farber Cancer Institute

People needed

840

Starts

2014-07-03

Expected to finish

2026-12-01

Last updated by the study team

2026-04-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• To participate in this study a participant must meet the eligibility of one of the following cohorts:
• Cohort 1: Cancers beginning initial treatment
• One of the following diagnoses:
• Cohort 1A (CLOSED):
• --Advanced non-squamous NSCLC (including adenosquamous)
• Cohort 1B:
• Stage II-III non-squamous NSCLC (including adenosquamous)
• Stage IIIB-IV melanoma
• Patient must be planned to begin initial therapy, or completely resected before or after receiving adjuvant therapy
• For patients with NSCLC, EGFR and KRAS genotype may be known or unknown
• For patients with melanoma, BRAF and NRAS genotype may be known or unknown
• For patients without tumor genotyping, there must be a plan for genotyping including either:
• Archived tumor tissue available and planned for genotyping
• A biopsy at some future time is anticipated and will be available for genotyping
• Cohort 2: Cancers with acquired resistance to targeted therapy
• One of the following diagnoses:
• Cohort 2A (CLOSED):
• --Advanced NSCLC harboring a known EGFR mutation
• Cohort 2B:
• Advanced NSCLC harboring a targetable genotype other than EGFR
• Advanced melanoma harboring a known tumor genotype
• Clinical determination of progression targeted therapy, as evidence by plans to start a new systemic treatment regimen, or obtain a biopsy to plan a new treatment regimen
• New systemic treatment regimen planned OR
• Re-biopsy for resistance genotyping planned
• Note, date of targeted therapy start and clinical progression must be provided

You may not qualify if…

• Participants who are unable to provide informed consent
• Participants who are 18 years of age or younger
• Participants who are unable to comply with the study procedures

Where it is running

• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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