Trials Sponsors Conditions Drugs Pricing

Conditions

KEAP1 Gene Mutation NFE2L2 Gene Mutation Non-Small Cell Lung Cancer Non-Squamous Non-Small Cell Neoplasm of Lung Non-squamous Non-small-cell Lung Cancer NRF2 Mutation

Keywords

NSCLCKEAP1NRF2NFE2L2LKB1STK11Next Generation SequencingNGSMutationGenePembrolizumabPemetrexedCarboplatinPlaceboRandomizedChemotherapyImmunotherapyTargeted TherapyTelaglenastatGlutamineGlutaminaseGlutathioneFront-lineFirst-lineNon-SquamousKeytrudaAlimtaGuardant360 LDT

Outcome Measures

Primary Outcomes (1)

Positive KEAP1 or NRF2/NFE2L2 mutational status, assessed by NGS of blood ctDNA
The percentage of patients with nonsquamous NSCLC containing pathogenic NRF2/NFE2L2 and/or KEAP1 mutations
Up to 16 months

Study Arms (1)

Biomarker Screening

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.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients with NSCLS with Mutation of KEAP1 or NRF2/NFE2L2 Genes

You may qualify if:

Patients with stage IV non-squamous non-small-cell lung cancer (NSCLC) who have not been previously treated with systemic therapy for metastatic disease, and meet all of the following:

Sponsors & Collaborators

Calithera Biosciences, Inc
Industrylead

Study Sites (63)

Southern Cancer Center

Daphne, Alabama, 36526, United States

Southern Cancer Center - 3 Mobile Infirmary Circle

Mobile, Alabama, 36607, United States

Southern Cancer Center - Dauphin St

Mobile, Alabama, 36608, United States

Southern Cancer Center - Providence Hospital

Mobile, Alabama, 36608, United States

Arizona Oncology Associates - Glendale

Glendale, Arizona, 85308, United States

Arizona Oncology Associates - E. Highland Ave.

Phoenix, Arizona, 85016, United States

Arizona Oncology Associates - N. 27th Ave.

Biospecimen

Retention: SAMPLES WITH DNA

Plasma for NGS analysis

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

Emil Kuriakose, MD
Calithera Biosciences, Inc
STUDY DIRECTOR

Enrollment

20 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 5, 2021

First Posted

January 7, 2021

Study Start

January 19, 2021

Actual (reported)

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Biomarker Screening

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (63)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Biomarker Screening

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (63)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations