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

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)

Sponsors

Lead Sponsor: Calithera Biosciences, Inc

Source Calithera Biosciences, Inc
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.

Overall Status Not yet recruiting
Start Date January 2021
Completion Date July 2022
Primary Completion Date May 2022
Phase Early Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Positive KEAP1 or NRF2/NFE2L2 mutational status, assessed by NGS of blood ctDNA Up to 16 months
Enrollment 200
Condition
Intervention

Intervention Type: Diagnostic Test

Intervention Name: Liquid Biopsy NGS Test

Description: Ct-DNA from blood samples collected from eligible patients will be analyzed using NGS for the presence of mutations in either the NRF2/NFE2L2 or KEAP1 genes.

Arm Group Label: Biomarker Screening

Eligibility

Criteria:

Inclusion Criteria: - Histologically or cytologically documented nonsquamous NSCLC with Stage IV (M1a-c, AJCC 8th Edition) disease not previously treated with systemic therapy for metastatic NSCLC a. Patients who received adjuvant or neoadjuvant therapy (with or without immunotherapy) for localized NSCLC are eligible if all adjuvant/neoadjuvant therapy (including immunotherapy) was completed at least 6 months prior to the development of metastatic disease. - No known actionable mutation in EGFR, ALK, ROS1, BRAF, NTRK or other known actionable mutation for which there is approved therapy. - Measurable disease per RECIST 1.1. - Life expectancy of at least 3 months. - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 - Age ≥ 18 years on the day of signing informed consent Exclusion Criteria: - Squamous cell histology and mixed histology tumors with any small-cell component (other mixed histology and large cell neuroendocrine histology is allowed). - Known history of malignancy within the past three years except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or other neoplasm that, in the opinion of the principal investigator and with the agreement of the medical monitor, will not interfere with study-specific endpoints. - Had radiation therapy to the lung > 30 Gy within 6 months prior to randomization on the KEAPSAKE trial. - Has active autoimmune disease that has required systemic treatment in past 2 years. - Is currently receiving chronic systemic steroids greater than 10 mg equivalent of prednisone per day. - Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ≤1.3 g per day, for a 5-day period (8-day period for long-acting agents). - Unable to swallow oral medications. - Known sensitivity to any component of the study treatment (pembrolizumab, carboplatin, pemetrexed, and/or telaglenastat) being tested in the KEAPSAKE trial or previous severe hypersensitivity to another monoclonal antibody - Unable or unwilling to take folic acid or vitamin B12 (intramuscular injection per label) supplementation. - Interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoid treatment - Unable or unwilling to discontinue proton pump inhibitors (PPI) at least 5 days before randomization on the KEAPSAKE trial

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Emil Kuriakose, MD Study Director Calithera Biosciences, Inc
Overall Contact

Last Name: Clinical Administrator

Phone: 650-870-1000

Email: [email protected]

Location
Facility: Contact: Investigator:
Southern Cancer Center | Daphne, Alabama, 36526, United States Karla Childers [email protected] Michael Meshad, MD Principal Investigator
Southern Cancer Center - 3 Mobile Infirmary Circle | Mobile, Alabama, 36607, United States Karla Childers [email protected] Michael Meshad, MD Principal Investigator
Southern Cancer Center - Dauphin St | Mobile, Alabama, 36608, United States Karla Childers [email protected] Michael Meshad, MD Principal Investigator
Southern Cancer Center - Providence Hospital | Mobile, Alabama, 36608, United States Karla Childers [email protected] Michael Meshad, MD Principal Investigator
Arizona Oncology Associates - Glendale | Glendale, Arizona, 85308, United States Leslie Fellers [email protected] Harshita Paripati, MD Principal Investigator
Arizona Oncology Associates - E. Highland Ave. | Phoenix, Arizona, 85016, United States Leslie Fellers [email protected] Harshita Paripati, MD Principal Investigator
Arizona Oncology Associates - N. 27th Ave. | Phoenix, Arizona, 85027, United States Leslie Fellers [email protected] Harshita Paripati, MD Principal Investigator
Arizona Oncology Associates | Scottsdale, Arizona, 85258, United States Leslie Fellers [email protected] Harshita Paripati, MD Principal Investigator
Arizona Oncology Associates - Tempe | Tempe, Arizona, 85284, United States Leslie Fellers [email protected] Harshita Paripati, MD Principal Investigator
Rocky Mountain Cancer Centers - Aurora | Aurora, Colorado, 80012, United States Katherine Schleich [email protected] Robert Jotte, MD Principal Investigator
Rocky Mountain Cancer Centers - Boulder | Boulder, Colorado, 80303, United States Katherine Schleich [email protected] Robert Jotte, MD Principal Investigator
Rocky Mountain Cancer Centers - Centennial | Centennial, Colorado, 80112, United States Katherine Schleich [email protected] Robert Jotte, MD Principal Investigator
Rocky Mountain Cancer Centers - Colorado Springs | Colorado Springs, Colorado, 80907, United States Katherine Schleich [email protected] Robert Jotte, MD Principal Investigator
Rocky Mountain Cancer Centers - Williams Street | Denver, Colorado, 80218, United States Katherine Schleich [email protected] Robert Jotte, MD Principal Investigator
Rocky Mountain Cancer Centers - E. Hale Parkway | Denver, Colorado, 80220, United States Katherine Schleich [email protected] Robert Jotte, MD Principal Investigator
Rocky Mountain Cancer Centers - Englewood | Englewood, Colorado, 80113, United States Katherine Schleich [email protected] Robert Jotte, MD Principal Investigator
Rocky Mountain Cancer Centers - Lakewood | Lakewood, Colorado, 80228, United States Katherine Schleich [email protected] Robert Jotte, MD Principal Investigator
Rocky Mountain Cancer Centers - Littleton | Littleton, Colorado, 80120-4413, United States Katherine Schleich [email protected] Robert Jotte, MD Principal Investigator
Rocky Mountain Cancer Centers - Lone Tree | Lone Tree, Colorado, 80124, United States Katherine Schleich [email protected] Robert Jotte, MD Principal Investigator
Rocky Mountain Cancer Centers - Longmont | Longmont, Colorado, 80501, United States Katherine Schleich [email protected] Robert Jotte, MD Principal Investigator
Rocky Mountain Cancer Centers - Pueblo | Pueblo, Colorado, 81008, United States Katherine Schleich [email protected] Robert Jotte, MD Principal Investigator
Rocky Mountain Cancer Centers - Thornton | Thornton, Colorado, 80260, United States Katherine Schleich [email protected] Robert Jotte, MD Principal Investigator
Medical Oncology Hematology Consultants | Newark, Delaware, 19713, United States Elizabeth MacWade [email protected] Jamal Misleh, MD Principal Investigator
Woodlands Medical Specialists | Pensacola, Florida, 32503, United States Leslie Bellamy [email protected] Rami Owera, MD Principal Investigator
Maryland Oncology Hematology - Bethesda | Bethesda, Maryland, 20817, United States Melissa Almand [email protected] Kashif Ali, MD Principal Investigator
Maryland Oncology Hematology - Brandywine | Brandywine, Maryland, 20613, United States Melissa Almand [email protected] Kashif Ali, MD Principal Investigator
Maryland Oncology Hematology - Clinton | Clinton, Maryland, 20735, United States Melissa Almand [email protected] Kashif Ali, MD Principal Investigator
Maryland Oncology Hematology | Columbia, Maryland, 21044, United States Melissa Almand [email protected] Kashif Ali, MD Principal Investigator
Maryland Hematology Oncology - Frederick | Frederick, Maryland, 21702, United States Melissa Almand [email protected] Kashif Ali, MD Principal Investigator
Maryland Oncology Hematology - Lanham | Lanham, Maryland, 20706, United States Melissa Almand [email protected] Kashif Ali, MD Principal Investigator
Maryland Hematology Oncology - Rockville | Rockville, Maryland, 20850, United States Melissa Almand [email protected] Kashif Ali, MD Principal Investigator
Maryland Hematology Oncology - Silver Spring | Silver Spring, Maryland, 20904, United States Melissa Almand [email protected] Kashif Ali, MD Principal Investigator
Oncology Hematology Care - Mercy Health Blvd | Cincinnati, Ohio, 45211, United States Nicole Clary [email protected] David Waterhouse, MD Principal Investigator
Oncology Hematology Care - Malsbary Rd | Cincinnati, Ohio, 45242, United States Nicole Clary [email protected] David Waterhouse, MD Principal Investigator
Oncology Hematology Care - Ivy Gateway | Cincinnati, Ohio, 45245, United States Nicole Clary [email protected]
Oncology Hematology Care - Fairfield | Fairfield, Ohio, 45014, United States Nicole Clary [email protected] David Waterhouse, MD Principal Investigator
Northwest Cancer Specialists - NE Hoyt St | Portland, Oregon, 97213-2982, United States Amy Campbell [email protected] Anthony Van Ho, MD Principal Investigator
Northwest Cancer Specialists - N. Broadway | Portland, Oregon, 97227, United States Amy Campbell [email protected] Anthony Van Ho, MD Principal Investigator
Northwest Cancer Specialists | Tigard, Oregon, 97223, United States Amy Campbell [email protected] Anthony Van Ho, MD Principal Investigator
Texas Oncology - West Texas Amarillo | Amarillo, Texas, 79106, United States Mary Williams [email protected] Philip Chae, MD Principal Investigator
Texas Oncology - Beaumont | Beaumont, Texas, 77701, United States Alana Brown [email protected] Scott A. McKenney, MD Principal Investigator
Texas Oncology - Beaumont Mamie McFaddin Ward Cancer Center | Beaumont, Texas, 77702-1449, United States Alana Brown [email protected] Scott A. McKenney, MD Principal Investigator
Texas Oncology - Carrollton | Carrollton, Texas, 75010, United States Kristen Tyree [email protected] Vibha T. Thomas, MD Principal Investigator
Texas Oncology - Denton | Denton, Texas, 76201, United States Nancy Smith [email protected] Charles V. Kurkul, MD Principal Investigator
Texas Oncology - Flower Mound | Flower Mound, Texas, 75028, United States Kristen Tyree [email protected] Vibha T. Thomas, MD Principal Investigator
Texas Oncology Cancer Care and Research | Harlingen, Texas, 78550, United States Nereida Salinas [email protected] Habib Ghaddar, MD Principal Investigator
Texas Oncology - Longview Cancer Center | Longview, Texas, 75601, United States Shelly Maxfield [email protected] Donald A. Richards, MD Principal Investigator
Texas Oncology - McAllen | McAllen, Texas, 78503, United States Salinas Nereida [email protected] Habib Ghaddar, MD Principal Investigator
Texas Oncology - West Texas Midland | Midland, Texas, 79701, United States Mary Williams [email protected] Philip Chae, MD Principal Investigator
Texas Oncology - West Texas Odessa | Odessa, Texas, 79761, United States Mary Williams [email protected] Philip Chae, MD Principal Investigator
Texas Oncology - Sherman | Sherman, Texas, 75090, United States Jayne Mettetal [email protected] Tammy E. Roque, MD Principal Investigator
Texas Oncology - Tyler | Tyler, Texas, 75702, United States Shelly Maxfield [email protected] Daniel A. Richards, MD Principal Investigator
Texas Oncology - Weslaco | Weslaco, Texas, 78596, United States Nereida Salinas [email protected] Habib Ghaddar, MD Principal Investigator
Texas Oncology - West Texas Wichita Falls | Wichita Falls, Texas, 76310, United States Mary Williams [email protected] Philip Chae, MD Principal Investigator
Virginia Cancer Specialists | Chesapeake, Virginia, 23320, United States Wendi Gobhardt [email protected] John C. Paschold, MD Principal Investigator
Virginia Oncology Associates | Hampton, Virginia, 23666, United States Wendi Gobhardt [email protected] John C. Paschold, MD Principal Investigator
Virginia Oncology Associates | Newport News, Virginia, 23606, United States Wendi Gobhardt [email protected] John C. Paschold, MD Principal Investigator
Virginia Cancer Specialists | Norfolk, Virginia, 23502, United States Wendi Gobhardt [email protected] John C. Paschold, MD Principal Investigator
Virginia Oncology Associates | Virginia Beach, Virginia, 23456, United States Wendi Gobhardt [email protected] John C. Paschold, MD Principal Investigator
Northwest Cancer Specialists | Vancouver, Washington, 98684, United States Amy Campbell [email protected] Anthony Van Ho, MD Principal Investigator
Location Countries

United States

Verification Date

January 2021

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Biomarker Screening

Type: Other

Description: 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.

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Intervention Model Description: Stage IV, 1L Nonsquamous NSCLC patients to be screened for KEAP1 or NRF2(NFE2L2) gene mutations

Primary Purpose: Screening

Masking: None (Open Label)

Source: ClinicalTrials.gov