A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Patients With Previously Treated KRAS G12C-Positive Advanced or Metastatic Non-Small Cell Lung Cancer

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Investigational drug late phase More information Active drug More information Low burden on patient More information

Trial Details

Sponsor: Hoffmann-La Roche (industry)

Phase: 3

Start date: Sept. 23, 2024

Planned enrollment: 320

Last updated in HealthScout: Dec 2024

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Trial ID: NCT06497556
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More trial details at ClinicalTrials.gov More info

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Goal: To evaluate the safety and efficacy of divarasib in comparison to existing KRAS G12C inhibitors, sotorasib and adagrasib, in patients with previously treated advanced or metastatic non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation.

Patients: The trial studies patients with advanced or metastatic non-small cell lung cancer with a confirmed KRAS G12C mutation. Participants must have experienced disease progression during or after treatment with one to three lines of prior systemic therapies. They should have a life expectancy of at least 12 weeks and an ECOG performance status of 0 or 1.

Design: This is a phase III, randomized, open-label, multicenter study involving a planned enrollment of 320 participants. The trial will allocate patients to receive either the investigational drug divarasib or the standard treatments sotorasib or adagrasib.

Treatments: This trial examines divarasib, an investigational oral KRAS G12C inhibitor by Genentech/Roche. Divarasib operates by selectively targeting the KRAS G12C mutation, locking the protein in an inactive state and inhibiting tumor growth. In phase 1 trials, divarasib demonstrated substantial efficacy with a 56.4% objective response rate in NSCLC patients and a manageable safety profile, mostly consisting of low-grade gastrointestinal adverse effects. As comparators, participants will either receive sotorasib or adagrasib, both approved KRAS G12C inhibitors known for their demonstrated efficacy in reducing tumor size in this patient population.

Outcomes: The primary outcome is progression-free survival (PFS), measured from randomization until disease progression or death. Secondary outcomes include overall survival (OS), objective response rate, duration of response, and quality of life metrics assessing symptom treatment toxicity. The trial will observe adverse events and patient-reported outcomes to further determine efficacy and safety.

Burden on patient: The trial involves oral administration of medications, aligning with standard care practices and thus posing a low burden on patients. Regular assessments for disease progression and overall health status are expected, similar to routine clinical care for advanced NSCLC. The necessity for a tumor biopsy for mutation confirmation and the follow-up for adverse events may present some additional requirements, but these are minimal and standard in clinical trials aimed at prolonging life and managing cancer symptoms.

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Status: Recruiting

University Hospitals of North Midlands NHS Trust-Royal Stoke University Hospital

Stoke-On-Trent, ST4 6QG, United Kingdom

No email / No phone

Status: Recruiting

Banner Health MD Anderson AZ

Gilbert, Arizona, 85234, United States

No email / No phone

Status: Recruiting

University of Arkansas For Medical Sciences

Little Rock, Arkansas, 72205, United States

No email / No phone

Status: Recruiting

UCLA Hematology / Oncology Clinic

Los Angeles, California, 90095, United States

No email / No phone

Status: Recruiting

Community Clinical Trials

Orange, California, 92868, United States

No email / No phone

Status: Recruiting

UC Health Oncology Research

Colorado Springs, Colorado, 80909, United States

No email / No phone

Status: Recruiting

Yale Cancer Center

New Haven, Connecticut, 06519, United States

No email / No phone

Status: Recruiting

Bay Pines Foundation Inc

Bay Pines, Florida, 33744, United States

No email / No phone

Status: Recruiting

Florida Cancer Specialists

West Palm Beach, Florida, 33401, United States

No email / No phone

Status: Recruiting

Florida Cancer Specialists.

Saint Petersburg, Florida, 33705, United States

No email / No phone

Status: Recruiting

Cancer Specialists of North Florida

Saint Augustine, Florida, 32086, United States

No email / No phone

Status: Recruiting

University of Miami

Miami, Florida, 33136, United States

No email / No phone

Status: Recruiting

Florida Cancer Specialists

Fort Myers, Florida, 33901, United States

No email / No phone

Status: Recruiting

University Cancer & Blood Center, LLC

Athens, Georgia, 30607, United States

No email / No phone

Status: Recruiting

Summit Cancer Care PC

Savannah, Georgia, 31405, United States

No email / No phone

Status: Recruiting

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

No email / No phone

Status: Recruiting

IU Health Ball Memorial Hospital

Muncie, Indiana, 47303, United States

No email / No phone

Status: Recruiting

Mission Cancer + Blood - IMMC

Des Moines, Iowa, 50309, United States

No email / No phone

Status: Recruiting

Norton Cancer Institute- Poplar

Louisville, Kentucky, 40217, United States

No email / No phone

Status: Recruiting

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

No email / No phone

Status: Recruiting

New England Cancer Specialists

Scarborough, Maine, 04074, United States

No email / No phone

Status: Recruiting

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

No email / No phone

Status: Recruiting

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

No email / No phone

Status: Recruiting

Henry Ford Health System;Clinical Trials Office

Detroit, Michigan, 48202, United States

No email / No phone

Status: Recruiting

University of Michigan

Ann Arbor, Michigan, 48109-0934, United States

No email / No phone

Status: Recruiting

Cancer and Hematology Centers of Western Michigan

Grand Rapids, Michigan, 49503, United States

No email / No phone

Status: Recruiting

Nebraska Methodist Estabrook Cancer Center

Omaha, Nebraska, 68114, United States

No email / No phone

Status: Recruiting

Renown Regional Medical Center Hospital

Reno, Nevada, 89502-1576, United States

No email / No phone

Status: Recruiting

Columbia University Medical Center

New York, New York, 10032, United States

No email / No phone

Status: Recruiting

New York Cancer & Blood Specialists

Bronx, New York, 10469, United States

No email / No phone

Status: Recruiting

New York Cancer & Blood Specialists - New Hyde Park

New Hyde Park, New York, 11042-1116, United States

No email / No phone

Status: Recruiting

New York Cancer and Blood Specialists-Central Park Hematology & Oncology

New York, New York, 10028, United States

No email / No phone

Status: Recruiting

Mount SInai Medical Center

New York, New York, 10029, United States

No email / No phone

Status: Recruiting

North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists

Shirley, New York, 11967, United States

No email / No phone

Status: Recruiting

University of North Carolina At Chapel Hill

Chapel Hill, North Carolina, 27514, United States

No email / No phone

Status: Recruiting

Firsthealth of The Carolinas

Pinehurst, North Carolina, 28374, United States

No email / No phone

Status: Recruiting

SCRI Mark H. Zangmeister Center

Columbus, Ohio, 43219, United States

No email / No phone

Status: Recruiting

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

No email / No phone

Status: Recruiting

Taylor Cancer Research Center

Maumee, Ohio, 43537, United States

No email / No phone

Status: Recruiting

Oncology Associates of Oregon, P.C

Eugene, Oregon, 97401, United States

No email / No phone

Status: Recruiting

Oregon Health & Science University

Portland, Oregon, 97239, United States

No email / No phone

Status: Recruiting

Allegheny Cancer Center

Pittsburgh, Pennsylvania, 15212, United States

No email / No phone

Status: Recruiting

Gibbs Cancer Center & Research Institute

Spartanburg, South Carolina, 29303, United States

No email / No phone

Status: Recruiting

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

No email / No phone

Status: Recruiting

Tennessee Oncology

Nashville, Tennessee, 37203, United States

No email / No phone

Status: Recruiting

Baptist Clinical Research Institute

Memphis, Tennessee, 38120, United States

No email / No phone

Status: Recruiting

Tennessee Oncology, PLLC - Chattanooga

Chattanooga, Tennessee, 37404, United States

No email / No phone

Status: Recruiting

MD Anderson Cancer Center

Houston, Texas, 77030, United States

No email / No phone

Status: Recruiting

JPS Health Network

Fort Worth, Texas, 76104, United States

No email / No phone

Status: Recruiting

Virginia Commonwealth University - Massey Cancer Center

Richmond, Virginia, 23298-0042, United States

No email / No phone

Status: Recruiting

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