Status:
RECRUITING
A Prospective Study of Plasma Genotyping as a Noninvasive Biomarker for Genotype-directed Cancer Care
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Damon Runyon Cancer Research Foundation
Conditions:
NSCLC
Melanoma
Eligibility:
All Genders
18+ years
Brief Summary
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 erlo...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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
- Cohort 3: Cancers with a known genotype starting palliative systemic therapy
- Cohort 3A (CLOSED):
- Advanced NSCLC harboring one of the following mutations:
- EGFR exon 19 deletion
- EGFR L858R
- EGFR T790M
- KRAS G12X
- BRAF V600E
- Patients must be initiating palliative systemic therapy, either on or off a clinical trial
- Cohort 4: Paired plasma NGS and ddPCR
- Cohort 4A (CLOSED):
- Advanced NSCLC, newly diagnosed or with progression following treatment.
- Biopsy tissue must be available or a biopsy planned and one of the following:
- Genotyping must have been performed previously
- Genotyping must be in progress
- A plan must exist to order genotyping on existing tissue or a planned re-biopsy
- Patient must not be eligible to enroll in cohort 1A or 2A due to:
- Not eligible for cohort 1A or 2A
- Eligible for cohort 1A or 2A but cohort has closed
- Cohort 4B: Undergenotyped NSCLC
- Advanced NSCLC, newly diagnosed or with progression following treatment.
- No known targetable genotype on prior tumor genotyping
- Biopsy planned for tumor genotyping
- Cohort 4C: EGFR-mutant NSCLC with acquired resistance
- Advanced EGFR-mutant NSCLC with progression on EGFR TKI
- Biopsy planned for resistance genotyping (e.g. T790M, etc)
- Cohort 5: Genotyped KRAS patients starting palliative systemic therapy
- Advanced NSCLC harboring a KRAS exon 2 mutation
- Patients must be initiating new systemic therapy, either on or off a clinical trial
- Exclusion Criteria
- 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
Exclusion
Key Trial Info
Start Date :
July 3 2014
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
840 Patients enrolled
Trial Details
Trial ID
NCT02279004
Start Date
July 3 2014
End Date
December 1 2026
Last Update
February 5 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215