Non-Small Cell Lung Cancer Clinical 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)
| Verified date | March 2023 |
| Source | Calithera Biosciences, Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| 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. |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Calithera Biosciences, Inc |
United States,
| 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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