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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04698681
Other study ID # CX-839-016
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date January 19, 2021
Est. completion date February 9, 2022

Study information

Verified date March 2023
Source Calithera Biosciences, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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). 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.


Recruitment information / eligibility

Status Terminated
Enrollment 20
Est. completion date February 9, 2022
Est. primary completion date November 5, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Texas Oncology - West Texas Amarillo Amarillo Texas
United States Rocky Mountain Cancer Centers - Aurora Aurora Colorado
United States Texas Oncology - Beaumont Beaumont Texas
United States Texas Oncology - Beaumont Mamie McFaddin Ward Cancer Center Beaumont Texas
United States Maryland Oncology Hematology - Bethesda Bethesda Maryland
United States Rocky Mountain Cancer Centers - Boulder Boulder Colorado
United States Maryland Oncology Hematology - Brandywine Brandywine Maryland
United States Consultants in Medical Oncology and Hematology Broomall Pennsylvania
United States Texas Oncology - Carrollton Carrollton Texas
United States Rocky Mountain Cancer Centers - Centennial Centennial Colorado
United States Virginia Oncology Associaties Chesapeake Virginia
United States Oncology Hematology Care - Ivy Gateway Cincinnati Ohio
United States Oncology Hematology Care - Malsbary Rd Cincinnati Ohio
United States Oncology Hematology Care - Mercy Health Blvd Cincinnati Ohio
United States Maryland Oncology Hematology - Clinton Clinton Maryland
United States Rocky Mountain Cancer Centers - Colorado Springs Colorado Springs Colorado
United States Maryland Oncology Hematology Columbia Maryland
United States Southern Cancer Center Daphne Alabama
United States Texas Oncology - Denton Denton Texas
United States Rocky Mountain Cancer Centers - E. Hale Parkway Denver Colorado
United States Rocky Mountain Cancer Centers - Williams Street Denver Colorado
United States Rocky Mountain Cancer Centers - Englewood Englewood Colorado
United States Oncology Hematology Care - Fairfield Fairfield Ohio
United States Texas Oncology - Flower Mound Flower Mound Texas
United States Maryland Hematology Oncology - Frederick Frederick Maryland
United States Arizona Oncology Associates - Glendale Glendale Arizona
United States Virginia Oncology Associates Hampton Virginia
United States Texas Oncology Cancer Care and Research Harlingen Texas
United States Consultants in Medical Oncology and Hematology Horsham Pennsylvania
United States Rocky Mountain Cancer Centers - Lakewood Lakewood Colorado
United States Maryland Oncology Hematology - Lanham Lanham Maryland
United States Rocky Mountain Cancer Centers - Littleton Littleton Colorado
United States Rocky Mountain Cancer Centers - Lone Tree Lone Tree Colorado
United States Rocky Mountain Cancer Centers - Longmont Longmont Colorado
United States Texas Oncology - Longview Cancer Center Longview Texas
United States Texas Oncology - McAllen McAllen Texas
United States Texas Oncology - West Texas Midland Midland Texas
United States Southern Cancer Center - 3 Mobile Infirmary Circle Mobile Alabama
United States Southern Cancer Center - Dauphin St Mobile Alabama
United States Southern Cancer Center - Providence Hospital Mobile Alabama
United States Medical Oncology Hematology Consultants Newark Delaware
United States Virginia Oncology Associates Newport News Virginia
United States Virginia Cancer Specialists Norfolk Virginia
United States Texas Oncology - West Texas Odessa Odessa Texas
United States Woodlands Medical Specialists Pensacola Florida
United States Arizona Oncology Associates - E. Highland Ave. Phoenix Arizona
United States Arizona Oncology Associates - N. 27th Ave. Phoenix Arizona
United States Northwest Cancer Specialists - N. Broadway Portland Oregon
United States Northwest Cancer Specialists - NE Hoyt St Portland Oregon
United States Rocky Mountain Cancer Centers - Pueblo Pueblo Colorado
United States Maryland Hematology Oncology - Rockville Rockville Maryland
United States Arizona Oncology Associates Scottsdale Arizona
United States Texas Oncology - Sherman Sherman Texas
United States Maryland Hematology Oncology - Silver Spring Silver Spring Maryland
United States Arizona Oncology Associates - Tempe Tempe Arizona
United States Rocky Mountain Cancer Centers - Thornton Thornton Colorado
United States Northwest Cancer Specialists Tigard Oregon
United States Texas Oncology - Tyler Tyler Texas
United States Northwest Cancer Specialists Vancouver Washington
United States Virginia Oncology Associates Virginia Beach Virginia
United States Texas Oncology - Weslaco Weslaco Texas
United States Texas Oncology - West Texas Wichita Falls Wichita Falls Texas
United States Consultants in Medical Oncology and Hematology Wynnewood Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Calithera Biosciences, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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