Status:
TERMINATED
NGS Screening Protocol to Detect Mutation of KEAP1 or NRF2/NFE2L2 Genes for the KEAPSAKE (CX-839-014) Trial
Lead Sponsor:
Calithera Biosciences, Inc
Conditions:
Non-Small Cell Lung Cancer
Non-squamous Non-small-cell Lung Cancer
Eligibility:
All Genders
18+ years
Brief 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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Any contraindication to pemetrexed, carboplatin, and Pembrolizumab treatment.
Key Trial Info
Start Date :
January 19 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 9 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04698681
Start Date
January 19 2021
End Date
February 9 2022
Last Update
March 13 2023
Active Locations (63)
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1
Southern Cancer Center
Daphne, Alabama, United States, 36526
2
Southern Cancer Center - 3 Mobile Infirmary Circle
Mobile, Alabama, United States, 36607
3
Southern Cancer Center - Dauphin St
Mobile, Alabama, United States, 36608
4
Southern Cancer Center - Providence Hospital
Mobile, Alabama, United States, 36608