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

NCT04698681 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2023-03-13

No results posted yet for this study

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.

Conditions

  • 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

Sponsors & Collaborators

  • Calithera Biosciences, Inc

    lead INDUSTRY

Principal Investigators

  • Emil Kuriakose, MD · Calithera Biosciences, Inc

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-19
Primary Completion
2021-11-05
Completion
2022-02-09

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04698681 on ClinicalTrials.gov