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NCT04698681 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by Calithera Biosciences.

Terminated
Registry status
20
Enrollment target

NCT04698681: Clinical Trial study, sponsored by Calithera Biosciences.

NCT04698681 is a clinical trial that was terminated before completion, run by Calithera Biosciences. The registered enrollment target is 20 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04698681 was terminated before completion, sponsored by Calithera Biosciences.

TERMINATED
Registry status
20 participants
Enrollment target

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.

Primary Outcome

The percentage of patients with nonsquamous NSCLC containing pathogenic NRF2/NFE2L2 and/or KEAP1 mutations

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2021-01-19
Est. Completion 2022-02-09
Calithera Biosciences

22 total trials

Why NCT04698681 stopped before completion

NCT04698681 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT04698681 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04698681 about?

NCT04698681 is a clinical study titled "NGS Screening Protocol to Detect Mutation of KEAP1 or NRF2/NFE2L2 Genes for the KEAPSAKE (CX-839-014) Trial". 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 ...

What is the current status of trial NCT04698681?

This trial is currently terminated. The enrollment target is 20 participants. The study started on 2021-01-19. Estimated completion is 2022-02-09.

Who is sponsoring clinical trial NCT04698681?

This trial is sponsored by Calithera Biosciences, which has 22 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT04698681, the US trial registry maintained by the National Library of Medicine. NCT04698681 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.