NGS Screening Protocol to Detect Mutation of KEAP1 or NRF2/NFE2L2 Genes for the KEAPSAKE (CX-839-014) Trial
Stopped early
Conditions studied: 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
In brief
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.
Key facts
- Study ID
- NCT04698681
- Run by
- Calithera Biosciences, Inc
- People needed
- 20
- Starts
- 2021-01-19
- Expected to finish
- 2022-02-09
- Last updated by the study team
- 2023-03-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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:
- Signed and dated NGS Informed Consent Form (ICF) by the patient (or legally acceptable representative (LAR), if applicable).
- Biopsy-confirmed OR clinically suspected stage IV NSCLC not previously treated with systemic therapy for metastatic disease.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Age ≥ 18 years old on the day of signing informed consent.
- Estimated life expectancy > 3 months.
- 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).
- Clinically eligible to receive standard-of-care combination therapy with pemetrexed + carboplatin + Pembrolizumab (PCP) for stage IV disease.
You may not qualify if…
- Any contraindication to pemetrexed, carboplatin, and Pembrolizumab treatment.
Where it is running
- Southern Cancer Center - 3 Mobile Infirmary Circle — Mobile, Alabama, United States
- Southern Cancer Center - Dauphin St — Mobile, Alabama, United States
- Southern Cancer Center - Providence Hospital — Mobile, Alabama, United States
- Arizona Oncology Associates - Glendale — Glendale, Arizona, United States
- Arizona Oncology Associates - E. Highland Ave. — Phoenix, Arizona, United States
- Arizona Oncology Associates - N. 27th Ave. — Phoenix, Arizona, United States
- Arizona Oncology Associates — Scottsdale, Arizona, United States
- Arizona Oncology Associates - Tempe — Tempe, Arizona, United States
- Rocky Mountain Cancer Centers - Aurora — Aurora, Colorado, United States
- Rocky Mountain Cancer Centers - Boulder — Boulder, Colorado, United States
- Rocky Mountain Cancer Centers - Centennial — Centennial, Colorado, United States
- Rocky Mountain Cancer Centers - Colorado Springs — Colorado Springs, Colorado, United States
- Rocky Mountain Cancer Centers - Williams Street — Denver, Colorado, United States
- Rocky Mountain Cancer Centers - E. Hale Parkway — Denver, Colorado, United States
- Rocky Mountain Cancer Centers - Englewood — Englewood, Colorado, United States
- Rocky Mountain Cancer Centers - Lakewood — Lakewood, Colorado, United States
- Rocky Mountain Cancer Centers - Littleton — Littleton, Colorado, United States
- Rocky Mountain Cancer Centers - Lone Tree — Lone Tree, Colorado, United States
- Rocky Mountain Cancer Centers - Longmont — Longmont, Colorado, United States
- Rocky Mountain Cancer Centers - Pueblo — Pueblo, Colorado, United States
- Rocky Mountain Cancer Centers - Thornton — Thornton, Colorado, United States
- Medical Oncology Hematology Consultants — Newark, Delaware, United States
- Woodlands Medical Specialists — Pensacola, Florida, United States
- Maryland Oncology Hematology - Bethesda — Bethesda, Maryland, United States
- Southern Cancer Center — Daphne, Alabama, United States
Full record on ClinicalTrials.gov
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