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

March 9, 2023 updated by: Calithera Biosciences, Inc

Screening Protocol to Detect Mutation of KEAP1 or NRF2/NFE2L2 Genes in Patients With Stage IV, 1L Non-Small Cell Lung Cancer to Determine Eligibility for the KEAPSAKE Clinical Trial (NCT04265534)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

20

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Daphne, Alabama, United States, 36526
        • Southern Cancer Center
      • Mobile, Alabama, United States, 36607
        • Southern Cancer Center - 3 Mobile Infirmary Circle
      • Mobile, Alabama, United States, 36608
        • Southern Cancer Center - Dauphin St
      • Mobile, Alabama, United States, 36608
        • Southern Cancer Center - Providence Hospital
    • Arizona
      • Glendale, Arizona, United States, 85308
        • Arizona Oncology Associates - Glendale
      • Phoenix, Arizona, United States, 85016
        • Arizona Oncology Associates - E. Highland Ave.
      • Phoenix, Arizona, United States, 85027
        • Arizona Oncology Associates - N. 27th Ave.
      • Scottsdale, Arizona, United States, 85258
        • Arizona Oncology Associates
      • Tempe, Arizona, United States, 85284
        • Arizona Oncology Associates - Tempe
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Rocky Mountain Cancer Centers - Aurora
      • Boulder, Colorado, United States, 80303
        • Rocky Mountain Cancer Centers - Boulder
      • Centennial, Colorado, United States, 80112
        • Rocky Mountain Cancer Centers - Centennial
      • Colorado Springs, Colorado, United States, 80907
        • Rocky Mountain Cancer Centers - Colorado Springs
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Centers - Williams Street
      • Denver, Colorado, United States, 80220
        • Rocky Mountain Cancer Centers - E. Hale Parkway
      • Englewood, Colorado, United States, 80113
        • Rocky Mountain Cancer Centers - Englewood
      • Lakewood, Colorado, United States, 80228
        • Rocky Mountain Cancer Centers - Lakewood
      • Littleton, Colorado, United States, 80120-4413
        • Rocky Mountain Cancer Centers - Littleton
      • Lone Tree, Colorado, United States, 80124
        • Rocky Mountain Cancer Centers - Lone Tree
      • Longmont, Colorado, United States, 80501
        • Rocky Mountain Cancer Centers - Longmont
      • Pueblo, Colorado, United States, 81008
        • Rocky Mountain Cancer Centers - Pueblo
      • Thornton, Colorado, United States, 80260
        • Rocky Mountain Cancer Centers - Thornton
    • Delaware
      • Newark, Delaware, United States, 19713
        • Medical Oncology Hematology Consultants
    • Florida
      • Pensacola, Florida, United States, 32503
        • Woodlands Medical Specialists
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Maryland Oncology Hematology - Bethesda
      • Brandywine, Maryland, United States, 20613
        • Maryland Oncology Hematology - Brandywine
      • Clinton, Maryland, United States, 20735
        • Maryland Oncology Hematology - Clinton
      • Columbia, Maryland, United States, 21044
        • Maryland Oncology Hematology
      • Frederick, Maryland, United States, 21702
        • Maryland Hematology Oncology - Frederick
      • Lanham, Maryland, United States, 20706
        • Maryland Oncology Hematology - Lanham
      • Rockville, Maryland, United States, 20850
        • Maryland Hematology Oncology - Rockville
      • Silver Spring, Maryland, United States, 20904
        • Maryland Hematology Oncology - Silver Spring
    • Ohio
      • Cincinnati, Ohio, United States, 45211
        • Oncology Hematology Care - Mercy Health Blvd
      • Cincinnati, Ohio, United States, 45242
        • Oncology Hematology Care - Malsbary Rd
      • Cincinnati, Ohio, United States, 45245
        • Oncology Hematology Care - Ivy Gateway
      • Fairfield, Ohio, United States, 45014
        • Oncology Hematology Care - Fairfield
    • Oregon
      • Portland, Oregon, United States, 97213-2982
        • Northwest Cancer Specialists - NE Hoyt St
      • Portland, Oregon, United States, 97227
        • Northwest Cancer Specialists - N. Broadway
      • Tigard, Oregon, United States, 97223
        • Northwest Cancer Specialists
    • Pennsylvania
      • Broomall, Pennsylvania, United States, 19008
        • Consultants in Medical Oncology and Hematology
      • Horsham, Pennsylvania, United States, 19044
        • Consultants in Medical Oncology and Hematology
      • Wynnewood, Pennsylvania, United States, 19096
        • Consultants in Medical Oncology and Hematology
    • Texas
      • Amarillo, Texas, United States, 79106
        • Texas Oncology - West Texas Amarillo
      • Beaumont, Texas, United States, 77701
        • Texas Oncology - Beaumont
      • Beaumont, Texas, United States, 77702-1449
        • Texas Oncology - Beaumont Mamie McFaddin Ward Cancer Center
      • Carrollton, Texas, United States, 75010
        • Texas Oncology - Carrollton
      • Denton, Texas, United States, 76201
        • Texas Oncology - Denton
      • Flower Mound, Texas, United States, 75028
        • Texas Oncology - Flower Mound
      • Harlingen, Texas, United States, 78550
        • Texas Oncology Cancer Care and Research
      • Longview, Texas, United States, 75601
        • Texas Oncology - Longview Cancer Center
      • McAllen, Texas, United States, 78503
        • Texas Oncology - McAllen
      • Midland, Texas, United States, 79701
        • Texas Oncology - West Texas Midland
      • Odessa, Texas, United States, 79761
        • Texas Oncology - West Texas Odessa
      • Sherman, Texas, United States, 75090
        • Texas Oncology - Sherman
      • Tyler, Texas, United States, 75702
        • Texas Oncology - Tyler
      • Weslaco, Texas, United States, 78596
        • Texas Oncology - Weslaco
      • Wichita Falls, Texas, United States, 76310
        • Texas Oncology - West Texas Wichita Falls
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • Virginia Oncology Associaties
      • Hampton, Virginia, United States, 23666
        • Virginia Oncology Associates
      • Newport News, Virginia, United States, 23606
        • Virginia Oncology Associates
      • Norfolk, Virginia, United States, 23502
        • Virginia Cancer Specialists
      • Virginia Beach, Virginia, United States, 23456
        • Virginia Oncology Associates
    • Washington
      • Vancouver, Washington, United States, 98684
        • Northwest Cancer Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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:

  1. Signed and dated NGS Informed Consent Form (ICF) by the patient (or legally acceptable representative (LAR), if applicable).
  2. Biopsy-confirmed OR clinically suspected stage IV NSCLC not previously treated with systemic therapy for metastatic disease.
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  4. Age ≥ 18 years old on the day of signing informed consent.
  5. Estimated life expectancy > 3 months.
  6. At least one radiographically measurable lesion per RECIST v1.1 defined as a lesion that is ≥ 10 mm in longest diameter or lymph node that is ≥ 15 mm in short axis imaged by computed tomography (CT) scan or magnetic resonance imaging (MRI).
  7. Clinically eligible to receive standard-of-care combination therapy with pemetrexed + carboplatin + Pembrolizumab (PCP) for stage IV disease.

Exclusion Criteria:

Any contraindication to pemetrexed, carboplatin, and Pembrolizumab treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Calithera Biosciences, Inc

Investigators

  • Study Director: Emil Kuriakose, MD, Calithera Biosciences, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2021

Primary Completion (Actual)

November 5, 2021

Study Completion (Actual)

February 9, 2022

Study Registration Dates

First Submitted

January 5, 2021

First Submitted That Met QC Criteria

January 5, 2021

First Posted (Actual)

January 7, 2021

Study Record Updates

Last Update Posted (Actual)

March 13, 2023

Last Update Submitted That Met QC Criteria

March 9, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CX-839-016

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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