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Purpose

The purpose of this study is to assess the safety and efficacy of divarasib compared to locally approved KRAS G12C inhibitors (sotorasib or adagrasib) in participants with KRAS G12C-positive (KRAS G12C +) advanced or metastatic non-small cell lung cancer (NSCLC).

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Unequivocal histologically or cytologically confirmed diagnosis of metastatic or locally advanced NSCLC not amenable to treatment with surgical resection or combined chemoradiation - Disease progression during or after treatment with at least one prior systemic therapy but no more than three lines of prior systemic therapy in the advanced or metastatic setting - Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 - Documentation of the presence of a KRAS G12C mutation - Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or 10-15 (15 preferred) unstained, freshly cut, serial slides with an associated pathology report - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Life expectancy of >= 12 weeks

Exclusion Criteria

  • Known hypersensitivity to any of the components of divarasib, or sotorasib or adagrasib - Malabsorption syndrome or other condition that would interfere with enteral absorption - Known concomitant second oncogenic driver - Mixed small-cell lung cancer or large cell neuroendocrine histology - Known and untreated, or active central nervous system (CNS) metastases - Leptomeningeal disease or carcinomatous meningitis - Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures biweekly or more frequently - Any infection that, in the opinion of the investigator, could impact patient safety, or treatment with therapeutic oral or IV antibiotics within 14 days prior to Day 1 of Cycle 1 - Prior treatment with any KRAS G12C inhibitor or pan-KRAS/RAS inhibitor - More than 30 Gy of radiotherapy to the lung within 6 months of randomization - Uncontrolled tumor-related pain - Unresolved toxicities from prior anticancer therapy - History of malignancy within 5 years prior to screening, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate >90%), such as adequately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Divarasib 		Participants will receive divarasib orally, once daily (QD).
  • Drug: Divarasib
    Divarasib will be administered orally QD
Active Comparator
KRAS G12C inhibitor 		Participants will receive Sotorasib orally QD or adagrasib orally twice a day (BID)
  • Drug: Sotorasib
    Sotorasib will be administered orally QD
  • Drug: Adagrasib
    Adagrasib will be administred orally BID

Recruiting Locations

Banner Health MD Anderson AZ
Gilbert, Arizona 85234

University of Arkansas For Medical Sciences
Little Rock, Arkansas 72205

UCLA Hematology / Oncology Clinic
Los Angeles, California 90095

Community Clinical Trials
Orange, California 92868

UC Health Oncology Research
Colorado Springs, Colorado 80909

Yale Cancer Center
New Haven, Connecticut 06519

Bay Pines Foundation Inc
Bay Pines, Florida 33744

Florida Cancer Specialists
Fort Myers, Florida 33901

University of Miami
Miami, Florida 33136

Cancer Specialists of North Florida
Saint Augustine, Florida 32086

Florida Cancer Specialists.
Saint Petersburg, Florida 33705

Florida Cancer Specialists
West Palm Beach, Florida 33401

University Cancer & Blood Center, LLC
Athens, Georgia 30607

Summit Cancer Care PC
Savannah, Georgia 31405

University of Chicago Medical Center
Chicago, Illinois 60637

IU Health Ball Memorial Hospital
Muncie, Indiana 47303

Mission Cancer + Blood - IMMC
Des Moines, Iowa 50309

Baptist Health Lexington
Lexington, Kentucky 40503

Norton Cancer Institute- Poplar
Louisville, Kentucky 40217

New England Cancer Specialists
Scarborough, Maine 04074

Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215

Dana Farber Cancer Institute
Boston, Massachusetts 02215

University of Michigan
Ann Arbor, Michigan 48109-0934

Henry Ford Health System;Clinical Trials Office
Detroit, Michigan 48202

Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan 49503

Nebraska Methodist Estabrook Cancer Center
Omaha, Nebraska 68114

Renown Regional Medical Center Hospital
Reno, Nevada 89502-1576

New York Cancer & Blood Specialists
Bronx, New York 10469

New York Cancer & Blood Specialists - New Hyde Park
New Hyde Park, New York 11042-1116

New York Cancer and Blood Specialists-Central Park Hematology & Oncology
New York, New York 10028

Mount SInai Medical Center
New York, New York 10029

Columbia University Medical Center
New York, New York 10032

North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
Shirley, New York 11967

University of North Carolina At Chapel Hill
Chapel Hill, North Carolina 27514

Firsthealth of The Carolinas
Pinehurst, North Carolina 28374

Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210

SCRI Mark H. Zangmeister Center
Columbus, Ohio 43219

Taylor Cancer Research Center
Maumee, Ohio 43537

Oncology Associates of Oregon, P.C
Eugene, Oregon 97401

Oregon Health & Science University
Portland, Oregon 97239

Allegheny Cancer Center
Pittsburgh, Pennsylvania 15212

Gibbs Cancer Center & Research Institute
Spartanburg, South Carolina 29303

Avera Cancer Institute
Sioux Falls, South Dakota 57105

Tennessee Oncology, PLLC - Chattanooga
Chattanooga, Tennessee 37404

Baptist Clinical Research Institute
Memphis, Tennessee 38120

Tennessee Oncology
Nashville, Tennessee 37203

JPS Health Network
Fort Worth, Texas 76104

MD Anderson Cancer Center
Houston, Texas 77030

Virginia Commonwealth University - Massey Cancer Center
Richmond, Virginia 23298-0042

More Details

NCT ID
NCT06497556
Status
Recruiting
Sponsor
Hoffmann-La Roche

Study Contact

Reference Study ID Number: BO45217 https://forpatients.roche.com/
888-662-6728 (U.S. and Canada)
global-roche-genentech-trials@gene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.