Clinical trialNCT04698681TerminatedObservational

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

SponsorCalithera Biosciences, IncEnrollment20KEAP1 Gene MutationNFE2L2 Gene MutationNRF2 MutationNon-Small Cell Lung CancerNon-Squamous Non-Small Cell Neoplasm of LungNon-squamous Non-small-cell Lung Cancer

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Emil Kuriakose, MD
Calithera Biosciences, Inc
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

63 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

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
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 - E. Hale Parkway
Denver, Colorado, United States
Rocky Mountain Cancer Centers - Williams Street
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
Maryland Oncology Hematology - Brandywine
Brandywine, Maryland, United States
Maryland Oncology Hematology - Clinton
Clinton, Maryland, United States
Maryland Oncology Hematology
Columbia, Maryland, United States
Maryland Hematology Oncology - Frederick
Frederick, Maryland, United States
Maryland Oncology Hematology - Lanham
Lanham, Maryland, United States
Maryland Hematology Oncology - Rockville
Rockville, Maryland, United States
Maryland Hematology Oncology - Silver Spring
Silver Spring, Maryland, United States
Oncology Hematology Care - Ivy Gateway
Cincinnati, Ohio, United States
Oncology Hematology Care - Malsbary Rd
Cincinnati, Ohio, United States
Oncology Hematology Care - Mercy Health Blvd
Cincinnati, Ohio, United States
Oncology Hematology Care - Fairfield
Fairfield, Ohio, United States
Northwest Cancer Specialists - N. Broadway
Portland, Oregon, United States
Northwest Cancer Specialists - Ne Hoyt St
Portland, Oregon, United States
Northwest Cancer Specialists
Tigard, Oregon, United States
Consultants in Medical Oncology and Hematology
Broomall, Pennsylvania, United States

23 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 19 Jan 2021
Primary completion: 5 Nov 2021
Completion: 9 Feb 2022
Last update posted: 13 Mar 2023
Registered enrollment: 20
Registry id: NCT04698681

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.