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NGS Screening Protocol to Detect Mutation of KEAP1 or NRF2/NFE2L2 Genes for the KEAPSAKE (CX-839-014) Trial
Brandywine, MD
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
No Placebo-Only Group
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.
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Eligible Conditions
- Non-Small Cell Lung Cancer
- Gene Mutation
- Adenocarcinoma
- NFE2L2 Gene Mutation
- NRF2 Mutation
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 16 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 16 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Positive KEAP1 or NRF2/NFE2L2 mutational status, assessed by NGS of blood ctDNA
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
Find a Location
Closest Location:Texas Oncology - West Texas Wichita Falls· Wichita Falls, TX· 276 miles
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