Clinical trial NCT04698681: NGS Screening Protocol to Detect Mutation of KEAP1 or NRF2/NFE2L2 Genes for the KEAPSAKE (CX-839-014) Trial
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)
Study type: OBSERVATIONAL
Overall status: TERMINATED
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
Glutaminase
Glutathione
Front-line
First-line
Non-Squamous
Keytruda
Alimta
Guardant360 LDT
Liquid Biopsy
ctDNA
Biomarker
Lead sponsor: Calithera Biosciences, Inc
Sponsor class: INDUSTRY
First posted: 2021-01-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with NSCLS with Mutation of KEAP1 or NRF2/NFE2L2 Genes

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Positive KEAP1 or NRF2/NFE2L2 mutational status, assessed by NGS of blood ctDNA
timeFrame: Up to 16 months
Secondary outcomes:
Other outcomes:
Locations:
city: Daphne
country: United States
facility: Southern Cancer Center
state: Alabama
city: Mobile
country: United States
facility: Southern Cancer Center - 3 Mobile Infirmary Circle
state: Alabama
city: Mobile
country: United States
facility: Southern Cancer Center - Dauphin St
state: Alabama
city: Mobile
country: United States
facility: Southern Cancer Center - Providence Hospital
state: Alabama
city: Glendale
country: United States
facility: Arizona Oncology Associates - Glendale
state: Arizona
city: Phoenix
country: United States
facility: Arizona Oncology Associates - E. Highland Ave.
state: Arizona
city: Phoenix
country: United States
facility: Arizona Oncology Associates - N. 27th Ave.
state: Arizona
city: Scottsdale
country: United States
facility: Arizona Oncology Associates
state: Arizona
city: Tempe
country: United States
facility: Arizona Oncology Associates - Tempe
state: Arizona
city: Aurora
country: United States
facility: Rocky Mountain Cancer Centers - Aurora
state: Colorado
city: Boulder
country: United States
facility: Rocky Mountain Cancer Centers - Boulder
state: Colorado
city: Centennial
country: United States
facility: Rocky Mountain Cancer Centers - Centennial
state: Colorado
city: Colorado Springs
country: United States
facility: Rocky Mountain Cancer Centers - Colorado Springs
state: Colorado
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers - Williams Street
state: Colorado
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers - E. Hale Parkway
state: Colorado
city: Englewood
country: United States
facility: Rocky Mountain Cancer Centers - Englewood
state: Colorado
city: Lakewood
country: United States
facility: Rocky Mountain Cancer Centers - Lakewood
state: Colorado
city: Littleton
country: United States
facility: Rocky Mountain Cancer Centers - Littleton
state: Colorado
city: Lone Tree
country: United States
facility: Rocky Mountain Cancer Centers - Lone Tree
state: Colorado
city: Longmont
country: United States
facility: Rocky Mountain Cancer Centers - Longmont
state: Colorado
city: Pueblo
country: United States
facility: Rocky Mountain Cancer Centers - Pueblo
state: Colorado
city: Thornton
country: United States
facility: Rocky Mountain Cancer Centers - Thornton
state: Colorado
city: Newark
country: United States
facility: Medical Oncology Hematology Consultants
state: Delaware
city: Pensacola
country: United States
facility: Woodlands Medical Specialists
state: Florida
city: Bethesda
country: United States
facility: Maryland Oncology Hematology - Bethesda
state: Maryland
city: Brandywine
country: United States
facility: Maryland Oncology Hematology - Brandywine
state: Maryland
city: Clinton
country: United States
facility: Maryland Oncology Hematology - Clinton
state: Maryland
city: Columbia
country: United States
facility: Maryland Oncology Hematology
state: Maryland
city: Frederick
country: United States
facility: Maryland Hematology Oncology - Frederick
state: Maryland
city: Lanham
country: United States
facility: Maryland Oncology Hematology - Lanham
state: Maryland
city: Rockville
country: United States
facility: Maryland Hematology Oncology - Rockville
state: Maryland
city: Silver Spring
country: United States
facility: Maryland Hematology Oncology - Silver Spring
state: Maryland
city: Cincinnati
country: United States
facility: Oncology Hematology Care - Mercy Health Blvd
state: Ohio
city: Cincinnati
country: United States
facility: Oncology Hematology Care - Malsbary Rd
state: Ohio
city: Cincinnati
country: United States
facility: Oncology Hematology Care - Ivy Gateway
state: Ohio
city: Fairfield
country: United States
facility: Oncology Hematology Care - Fairfield
state: Ohio
city: Portland
country: United States
facility: Northwest Cancer Specialists - NE Hoyt St
state: Oregon
city: Portland
country: United States
facility: Northwest Cancer Specialists - N. Broadway
state: Oregon
city: Tigard
country: United States
facility: Northwest Cancer Specialists
state: Oregon
city: Broomall
country: United States
facility: Consultants in Medical Oncology and Hematology
state: Pennsylvania
city: Horsham
country: United States
facility: Consultants in Medical Oncology and Hematology
state: Pennsylvania
city: Wynnewood
country: United States
facility: Consultants in Medical Oncology and Hematology
state: Pennsylvania
city: Amarillo
country: United States
facility: Texas Oncology - West Texas Amarillo
state: Texas
city: Beaumont
country: United States
facility: Texas Oncology - Beaumont
state: Texas
city: Beaumont
country: United States
facility: Texas Oncology - Beaumont Mamie McFaddin Ward Cancer Center
state: Texas
city: Carrollton
country: United States
facility: Texas Oncology - Carrollton
state: Texas
city: Denton
country: United States
facility: Texas Oncology - Denton
state: Texas
city: Flower Mound
country: United States
facility: Texas Oncology - Flower Mound
state: Texas
city: Harlingen
country: United States
facility: Texas Oncology Cancer Care and Research
state: Texas
city: Longview
country: United States
facility: Texas Oncology - Longview Cancer Center
state: Texas
city: McAllen
country: United States
facility: Texas Oncology - McAllen
state: Texas
city: Midland
country: United States
facility: Texas Oncology - West Texas Midland
state: Texas
city: Odessa
country: United States
facility: Texas Oncology - West Texas Odessa
state: Texas
city: Sherman
country: United States
facility: Texas Oncology - Sherman
state: Texas
city: Tyler
country: United States
facility: Texas Oncology - Tyler
state: Texas
city: Weslaco
country: United States
facility: Texas Oncology - Weslaco
state: Texas
city: Wichita Falls
country: United States
facility: Texas Oncology - West Texas Wichita Falls
state: Texas
city: Chesapeake
country: United States
facility: Virginia Oncology Associaties
state: Virginia
city: Hampton
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Newport News
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Norfolk
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: Virginia Beach
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Vancouver
country: United States
facility: Northwest Cancer Specialists
state: Washington
Study officials:
affiliation: Calithera Biosciences, Inc
name: Emil Kuriakose, MD
role: STUDY_DIRECTOR
References: