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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Calithera Biosciences, Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 19, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 5, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 9, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 7, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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