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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Mar 13, 2023 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Observational
Locations may change over time.
Study sponsor
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
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
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.
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.