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

Terminated

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

• Registration Number: NCT04698681
• Lead Sponsor: Calithera Biosciences, Inc

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-05
• Study First Submitted QC: 2021-01-05
• Study First Posted: 2021-01-07
• Study Start: 2021-01-19
• Primary Completion: 2021-11-05
• Study Completion: 2022-02-09
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-09
• Last Update Posted: 2023-03-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Positive KEAP1 or NRF2/NFE2L2 mutational status, assessed by NGS of blood ctDNA	Up to 16 months	The percentage of patients with nonsquamous NSCLC containing pathogenic NRF2/NFE2L2 and/or KEAP1 mutations

Trial Locations

Locations (58)

Southern Cancer Center; 🇺🇸 Daphne, Alabama, United States

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

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