Non-Small Cell Lung CancerNCT04698681
NGS Screening Protocol to Detect Mutation of KEAP1 or NRF2/NFE2L2 Genes for the KEAPSAKE (CX-839-014) Trial
An observational study of Non-Small Cell Lung Cancer and Non-squamous Non-small-cell Lung Cancer, run by Calithera Biosciences, Inc at 63 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer, Non-squamous Non-small-cell Lung Cancer, Non-Squamous Non-Small Cell Neoplasm of Lung
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 63 sitesUnited States
- Study dates
- 19 Jan 2021to 9 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with NSCLS with Mutation of KEAP1 or NRF2/NFE2L2 Genes
Who may be able to join
- 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:
- Signed and dated NGS Informed Consent Form (ICF) by the patient (or legally acceptable representative (LAR), if applicable).
- Biopsy-confirmed OR clinically suspected stage IV NSCLC not previously treated with systemic therapy for metastatic disease.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Age ≥ 18 years old on the day of signing informed consent.
- Estimated life expectancy > 3 months.
- 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).
- Clinically eligible to receive standard-of-care combination therapy with pemetrexed + carboplatin + Pembrolizumab (PCP) for stage IV disease.
Who cannot join
- Any contraindication to pemetrexed, carboplatin, and Pembrolizumab treatment.
Trial locations and contacts
63 sites in 1 country.
63 sites in 1 country
United States63 sites
Texas Oncology - West Texas Amarillo
Amarillo, Texas, 79106
Rocky Mountain Cancer Centers - Aurora
Aurora, Colorado, 80012
Texas Oncology - Beaumont
Beaumont, Texas, 77701
Texas Oncology - Beaumont Mamie McFaddin Ward Cancer Center
Beaumont, Texas, 77702-1449
Maryland Oncology Hematology - Bethesda
Bethesda, Maryland, 20817
Rocky Mountain Cancer Centers - Boulder
Boulder, Colorado, 80303
Maryland Oncology Hematology - Brandywine
Brandywine, Maryland, 20613
Consultants in Medical Oncology and Hematology
Broomall, Pennsylvania, 19008
Texas Oncology - Carrollton
Carrollton, Texas, 75010
Rocky Mountain Cancer Centers - Centennial
Centennial, Colorado, 80112
Virginia Oncology Associaties
Chesapeake, Virginia, 23320
Oncology Hematology Care - Mercy Health Blvd
Cincinnati, Ohio, 45211
Oncology Hematology Care - Malsbary Rd
Cincinnati, Ohio, 45242
Oncology Hematology Care - Ivy Gateway
Cincinnati, Ohio, 45245
Maryland Oncology Hematology - Clinton
Clinton, Maryland, 20735
Rocky Mountain Cancer Centers - Colorado Springs
Colorado Springs, Colorado, 80907
Maryland Oncology Hematology
Columbia, Maryland, 21044
Southern Cancer Center
Daphne, Alabama, 36526
Texas Oncology - Denton
Denton, Texas, 76201
Rocky Mountain Cancer Centers - Williams Street
Denver, Colorado, 80218
Rocky Mountain Cancer Centers - E. Hale Parkway
Denver, Colorado, 80220
Rocky Mountain Cancer Centers - Englewood
Englewood, Colorado, 80113
Oncology Hematology Care - Fairfield
Fairfield, Ohio, 45014
Texas Oncology - Flower Mound
Flower Mound, Texas, 75028
Maryland Hematology Oncology - Frederick
Frederick, Maryland, 21702
Arizona Oncology Associates - Glendale
Glendale, Arizona, 85308
Virginia Oncology Associates
Hampton, Virginia, 23666
Texas Oncology Cancer Care and Research
Harlingen, Texas, 78550
Consultants in Medical Oncology and Hematology
Horsham, Pennsylvania, 19044
Rocky Mountain Cancer Centers - Lakewood
Lakewood, Colorado, 80228
Maryland Oncology Hematology - Lanham
Lanham, Maryland, 20706
Rocky Mountain Cancer Centers - Littleton
Littleton, Colorado, 80120-4413
Rocky Mountain Cancer Centers - Lone Tree
Lone Tree, Colorado, 80124
Rocky Mountain Cancer Centers - Longmont
Longmont, Colorado, 80501
Texas Oncology - Longview Cancer Center
Longview, Texas, 75601
Texas Oncology - McAllen
McAllen, Texas, 78503
Texas Oncology - West Texas Midland
Midland, Texas, 79701
Southern Cancer Center - 3 Mobile Infirmary Circle
Mobile, Alabama, 36607
Southern Cancer Center - Dauphin St
Mobile, Alabama, 36608
Southern Cancer Center - Providence Hospital
Mobile, Alabama, 36608
Medical Oncology Hematology Consultants
Newark, Delaware, 19713
Virginia Oncology Associates
Newport News, Virginia, 23606
Virginia Cancer Specialists
Norfolk, Virginia, 23502
Texas Oncology - West Texas Odessa
Odessa, Texas, 79761
Woodlands Medical Specialists
Pensacola, Florida, 32503
Arizona Oncology Associates - E. Highland Ave.
Phoenix, Arizona, 85016
Arizona Oncology Associates - N. 27th Ave.
Phoenix, Arizona, 85027
Northwest Cancer Specialists - NE Hoyt St
Portland, Oregon, 97213-2982
Northwest Cancer Specialists - N. Broadway
Portland, Oregon, 97227
Rocky Mountain Cancer Centers - Pueblo
Pueblo, Colorado, 81008
Maryland Hematology Oncology - Rockville
Rockville, Maryland, 20850
Arizona Oncology Associates
Scottsdale, Arizona, 85258
Texas Oncology - Sherman
Sherman, Texas, 75090
Maryland Hematology Oncology - Silver Spring
Silver Spring, Maryland, 20904
Arizona Oncology Associates - Tempe
Tempe, Arizona, 85284
Rocky Mountain Cancer Centers - Thornton
Thornton, Colorado, 80260
Northwest Cancer Specialists
Tigard, Oregon, 97223
Texas Oncology - Tyler
Tyler, Texas, 75702
Northwest Cancer Specialists
Vancouver, Washington, 98684
Virginia Oncology Associates
Virginia Beach, Virginia, 23456
Texas Oncology - Weslaco
Weslaco, Texas, 78596
Texas Oncology - West Texas Wichita Falls
Wichita Falls, Texas, 76310
Consultants in Medical Oncology and Hematology
Wynnewood, Pennsylvania, 19096
About this study
Official title: 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.
- Conditions
- Non-Small Cell Lung Cancer, Non-squamous Non-small-cell Lung Cancer, Non-Squamous Non-Small Cell Neoplasm of Lung, KEAP1 Gene Mutation, NRF2 Mutation, NFE2L2 Gene Mutation
- Keywords
- NSCLC, KEAP1, NRF2, NFE2L2, LKB1, STK11, Next Generation Sequencing, NGS, Mutation, Gene, Pembrolizumab, Pemetrexed, Carboplatin, Placebo, Randomized, Chemotherapy, Immunotherapy, Targeted Therapy, Telaglenastat, Glutamine
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start19 Jan 2021
- Primary completion5 Nov 2021
- Study completion9 Feb 2022
Why it stopped: Lack of Clinical Benefit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Calithera Biosciences, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emil Kuriakose, MD, Study director, Calithera Biosciences, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04698681
- Sponsor's protocol ID
- CX-839-016
- Status last verified
- Mar 2023
- First submitted
- 5 Jan 2021
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04698681
- Acronym / sponsor ID
- CX-839-016
- Conditions
- Non-Small Cell Lung Cancer, Non-squamous Non-small-cell Lung Cancer, Non-Squamous Non-Small Cell Neoplasm of Lung, KEAP1 Gene Mutation, NRF2 Mutation, NFE2L2 Gene Mutation
- Keywords
- NSCLC, KEAP1, NRF2, NFE2L2, LKB1, STK11, Next Generation Sequencing, NGS
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of Clinical Benefit
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Calithera Biosciences, IncIndustry (pharma, biotech, devices)
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- 5 Nov 2021 (actual)
- Study completion
- 9 Feb 2022 (actual)
- First posted
- 7 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with NSCLS with Mutation of KEAP1 or NRF2/NFE2L2 Genes
Key inclusion criteria (8 listed)
- 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:
- Signed and dated NGS Informed Consent Form (ICF) by the patient (or legally acceptable representative (LAR), if applicable).
- Biopsy-confirmed OR clinically suspected stage IV NSCLC not previously treated with systemic therapy for metastatic disease.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Age ≥ 18 years old on the day of signing informed consent.
Key exclusion criteria (1 listed)
- Any contraindication to pemetrexed, carboplatin, and Pembrolizumab treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study was stopped early (reason given: Lack of Clinical Benefit). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emil Kuriakose, MD study director
Calithera Biosciences, Inc
63 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer and Non-squamous Non-small-cell Lung Cancer, run by Calithera Biosciences, Inc at 63 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 63 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of Clinical Benefit). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive KEAP1 or NRF2/NFE2L2 mutational status, assessed by NGS of blood ctDNA (time frame: Up to 16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023.