NGS Screening Protocol to Detect Mutation of KEAP1 or NRF2/NFE2L2 Genes for the KEAPSAKE (CX-839-014) Trial

Calithera Biosciences

Status and phase: Terminated; Early Phase 1

Conditions: NFE2L2 Gene Mutation; Non-Squamous Non-Small Cell Neoplasm of Lung; KEAP1 Gene Mutation; Non-squamous Non-small-cell Lung Cancer; Non-Small Cell Lung Cancer; NRF2 Mutation

Study type: Observational

Funder types: Industry

Identifiers

NCT04698681

CX-839-016

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

20 participants in 1 patient group

Biomarker Screening

Description:

Patients with stage IV nonsquamous NSCLC not previously treated with systemic therapy for metastatic disease and who meet all of study inclusion criteria and none of the exclusion criteria.