NGS Screening Protocol to Detect Mutation of KEAP1 or NRF2/NFE2L2 Genes for the KEAPSAKE (CX-839-014) Trial
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.
Checked against the public recordLast updated Mar 13, 2023 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Not specified
- Study type
- Observational
- Phase
- Not applicable
- Sponsor
- Calithera Biosciences, Inc
- Interventions being studied
- Not specified
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: Patients with stage IV non-squamous non-small-cell lung cancer (NSCLC) who have not been previously treated with systemic therapy for metastatic disease, and meet all of the following: 1. Signed and dated NGS Informed Consent Form (ICF) by the patient (or legally acceptable representative (LAR), if applicable). 2. Biopsy-confirmed OR clinically suspected stage IV NSCLC not previously treated with systemic therapy for metastatic disease. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Age ≥ 18 years old on the day of signing informed consent. 5. Estimated life expectancy \> 3 months. 6. At least one radiographically measurable lesion per RECIST v1.1 defined as a lesion that is ≥ 10 mm in longest diameter or lymph node that is ≥ 15 mm in short axis imaged by computed tomography (CT) scan or magnetic resonance imaging (MRI). 7. Clinically eligible to receive standard-of-care combination therapy with pemetrexed + carboplatin + Pembrolizumab (PCP) for stage IV disease. Exclusion Criteria: Any contraindication to pemetrexed, carboplatin, and Pembrolizumab treatment.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Southern Cancer CenterDaphne, Alabama
- Southern Cancer Center - 3 Mobile Infirmary CircleMobile, Alabama
- Southern Cancer Center - Dauphin StMobile, Alabama
- Southern Cancer Center - Providence HospitalMobile, Alabama
- Arizona Oncology Associates - GlendaleGlendale, Arizona
- Arizona Oncology Associates - E. Highland Ave.Phoenix, Arizona
- Arizona Oncology Associates - N. 27th Ave.Phoenix, Arizona
- Arizona Oncology AssociatesScottsdale, Arizona
- Arizona Oncology Associates - TempeTempe, Arizona
- Rocky Mountain Cancer Centers - AuroraAurora, Colorado
- Rocky Mountain Cancer Centers - BoulderBoulder, Colorado
- Rocky Mountain Cancer Centers - CentennialCentennial, Colorado
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 13, 2023. Always confirm current availability with the study team.