TerminatedNot applicableNCT04698681

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

StatusTerminated
PhaseNot applicable
U.S. locations63
SponsorCalithera Biosciences, Inc
01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
Calithera Biosciences, Inc
Interventions being studied
Not specified
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

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.

04
Study sites

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.

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