A Prospective Study of Plasma Genotyping as a Noninvasive Biomarker for Genotype-directed Cancer Care
A Prospective Study of Plasma Genotyping as a Noninvasive Biomarker for Genotype-directed Cancer Care
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.
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:
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:
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:
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
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:
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:
Patient must not be eligible to enroll in cohort 1A or 2A due to:
Cohort 4B: Undergenotyped NSCLC
Cohort 4C: EGFR-mutant NSCLC with acquired resistance
Cohort 5: Genotyped KRAS patients starting palliative systemic therapy
Exclusion Criteria