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

NCT04698681 | Terminated

• 1 other identifier: CX-839-016
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 63

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.

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

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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-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:
• 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.

You may not qualify if:

• Any contraindication to pemetrexed, carboplatin, and Pembrolizumab treatment.

Sponsors & Collaborators

• Calithera Biosciences, Inc: lead

Study Sites (63)

Southern Cancer Center

Daphne, Alabama, 36526, United States

Location

Southern Cancer Center - 3 Mobile Infirmary Circle

Mobile, Alabama, 36607, United States

Location

Southern Cancer Center - Dauphin St

Mobile, Alabama, 36608, United States

Location

Southern Cancer Center - Providence Hospital

Mobile, Alabama, 36608, United States

Location

Arizona Oncology Associates - Glendale

Glendale, Arizona, 85308, United States

Location

Arizona Oncology Associates - E. Highland Ave.

Phoenix, Arizona, 85016, United States

Location

Arizona Oncology Associates - N. 27th Ave.

Phoenix, Arizona, 85027, United States

Location

Arizona Oncology Associates

Scottsdale, Arizona, 85258, United States

Location

Arizona Oncology Associates - Tempe

Tempe, Arizona, 85284, United States

Location

Rocky Mountain Cancer Centers - Aurora

Aurora, Colorado, 80012, United States

Location

Rocky Mountain Cancer Centers - Boulder

Boulder, Colorado, 80303, United States

Location

Rocky Mountain Cancer Centers - Centennial

Centennial, Colorado, 80112, United States

Location

Rocky Mountain Cancer Centers - Colorado Springs

Colorado Springs, Colorado, 80907, United States

Location

Rocky Mountain Cancer Centers - Williams Street

Denver, Colorado, 80218, United States

Location

Rocky Mountain Cancer Centers - E. Hale Parkway

Denver, Colorado, 80220, United States

Location

Rocky Mountain Cancer Centers - Englewood

Englewood, Colorado, 80113, United States

Location

Rocky Mountain Cancer Centers - Lakewood

Lakewood, Colorado, 80228, United States

Location

Rocky Mountain Cancer Centers - Littleton

Littleton, Colorado, 80120-4413, United States

Location

Rocky Mountain Cancer Centers - Lone Tree

Lone Tree, Colorado, 80124, United States

Location

Rocky Mountain Cancer Centers - Longmont

Longmont, Colorado, 80501, United States

Location

Rocky Mountain Cancer Centers - Pueblo

Pueblo, Colorado, 81008, United States

Location

Rocky Mountain Cancer Centers - Thornton

Thornton, Colorado, 80260, United States

Location

Medical Oncology Hematology Consultants

Newark, Delaware, 19713, United States

Location

Woodlands Medical Specialists

Pensacola, Florida, 32503, United States

Location

Maryland Oncology Hematology - Bethesda

Bethesda, Maryland, 20817, United States

Location

Maryland Oncology Hematology - Brandywine

Brandywine, Maryland, 20613, United States

Location

Maryland Oncology Hematology - Clinton

Clinton, Maryland, 20735, United States

Location

Maryland Oncology Hematology

Columbia, Maryland, 21044, United States

Location

Maryland Hematology Oncology - Frederick

Frederick, Maryland, 21702, United States

Location

Maryland Oncology Hematology - Lanham

Lanham, Maryland, 20706, United States

Location

Maryland Hematology Oncology - Rockville

Rockville, Maryland, 20850, United States

Location

Maryland Hematology Oncology - Silver Spring

Silver Spring, Maryland, 20904, United States

Location

Oncology Hematology Care - Mercy Health Blvd

Cincinnati, Ohio, 45211, United States

Location

Oncology Hematology Care - Malsbary Rd

Cincinnati, Ohio, 45242, United States

Location

Oncology Hematology Care - Ivy Gateway

Cincinnati, Ohio, 45245, United States

Location

Oncology Hematology Care - Fairfield

Fairfield, Ohio, 45014, United States

Location

Northwest Cancer Specialists - NE Hoyt St

Portland, Oregon, 97213-2982, United States

Location

Northwest Cancer Specialists - N. Broadway

Portland, Oregon, 97227, United States

Location

Northwest Cancer Specialists

Tigard, Oregon, 97223, United States

Location

Consultants in Medical Oncology and Hematology

Broomall, Pennsylvania, 19008, United States

Location

Consultants in Medical Oncology and Hematology

Horsham, Pennsylvania, 19044, United States

Location

Consultants in Medical Oncology and Hematology

Wynnewood, Pennsylvania, 19096, United States

Location

Texas Oncology - West Texas Amarillo

Amarillo, Texas, 79106, United States

Location

Texas Oncology - Beaumont

Beaumont, Texas, 77701, United States

Location

Texas Oncology - Beaumont Mamie McFaddin Ward Cancer Center

Beaumont, Texas, 77702-1449, United States

Location

Texas Oncology - Carrollton

Carrollton, Texas, 75010, United States

Location

Texas Oncology - Denton

Denton, Texas, 76201, United States

Location

Texas Oncology - Flower Mound

Flower Mound, Texas, 75028, United States

Location

Texas Oncology Cancer Care and Research

Harlingen, Texas, 78550, United States

Location

Texas Oncology - Longview Cancer Center

Longview, Texas, 75601, United States

Location

Texas Oncology - McAllen

McAllen, Texas, 78503, United States

Location

Texas Oncology - West Texas Midland

Midland, Texas, 79701, United States

Location

Texas Oncology - West Texas Odessa

Odessa, Texas, 79761, United States

Location

Texas Oncology - Sherman

Sherman, Texas, 75090, United States

Location

Texas Oncology - Tyler

Tyler, Texas, 75702, United States

Location

Texas Oncology - Weslaco

Weslaco, Texas, 78596, United States

Location

Texas Oncology - West Texas Wichita Falls

Wichita Falls, Texas, 76310, United States

Location

Virginia Oncology Associaties

Chesapeake, Virginia, 23320, United States

Location

Virginia Oncology Associates

Hampton, Virginia, 23666, United States

Location

Virginia Oncology Associates

Newport News, Virginia, 23606, United States

Location

Virginia Cancer Specialists

Norfolk, Virginia, 23502, United States

Location

Virginia Oncology Associates

Virginia Beach, Virginia, 23456, United States

Location

Northwest Cancer Specialists

Vancouver, Washington, 98684, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma for NGS analysis

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Emil Kuriakose, MD

  Calithera Biosciences, Inc

  STUDY DIRECTOR

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
• Primary Completion: November 5, 2021
• Study Completion: February 9, 2022
• Last Updated: March 13, 2023

Record last verified: 2023-03

Locations

US (63)