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Biomarker Screening for Non-Small Cell Lung Cancer

N/A
Waitlist Available
Research Sponsored by Calithera Biosciences, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 16 months
Awards & highlights

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.

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Gene Mutation
  • NRF2 Mutation
  • NFE2L2 Gene Mutation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 16 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 16 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Positive KEAP1 or NRF2/NFE2L2 mutational status, assessed by NGS of blood ctDNA

Trial Design

1Treatment groups
Experimental Treatment
Group I: Biomarker ScreeningExperimental Treatment1 Intervention
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.

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Who is running the clinical trial?

Calithera Biosciences, IncLead Sponsor
33 Previous Clinical Trials
2,001 Total Patients Enrolled
Emil Kuriakose, MDStudy DirectorCalithera Biosciences, Inc
3 Previous Clinical Trials
353 Total Patients Enrolled
~4 spots leftby Sep 2025
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