Trials / Terminated
TerminatedNCT04698681
NGS Screening Protocol to Detect Mutation of KEAP1 or NRF2/NFE2L2 Genes for the KEAPSAKE (CX-839-014) Trial
Screening Protocol to Detect Mutation of KEAP1 or NRF2/NFE2L2 Genes in Patients With Stage IV, 1L Non-Small Cell Lung Cancer to Determine Eligibility for the KEAPSAKE Clinical Trial (NCT04265534)
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 20 (actual)
- Sponsor
- Calithera Biosciences, Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicenter screening protocol designed to identify patients with NSCLC who have tumor mutations in the KEAP1 or NRF2/NFE2L2 genes in order to determine potential eligibility for a biomarker selected clinical trial (CX-839-014, otherwise known as the KEAPSAKE trial). Circulating tumor DNA (ctDNA) present in blood samples collected from eligible patients will be analyzed by next generation sequencing (NGS) for selected biomarkers. A commercial liquid biopsy NGS test will be provided to study participants free of charge.
Conditions
- Non-Small Cell Lung Cancer
- Non-squamous Non-small-cell Lung Cancer
- Non-Squamous Non-Small Cell Neoplasm of Lung
- KEAP1 Gene Mutation
- NRF2 Mutation
- NFE2L2 Gene Mutation
Timeline
- Start date
- 2021-01-19
- Primary completion
- 2021-11-05
- Completion
- 2022-02-09
- First posted
- 2021-01-07
- Last updated
- 2023-03-13
Locations
63 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT04698681. Inclusion in this directory is not an endorsement.