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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 Sex
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 5295903, Arizona 5551752 85234

Banner Health MD Anderson AZ
Phoenix 5308655, Arizona 5551752 85006

University of Arkansas For Medical Sciences
Little Rock 4119403, Arkansas 4099753 72205

Los Angeles Cancer Network
Los Angeles 5368361, California 5332921 90017-4803

UCLA Hematology / Oncology Clinic
Los Angeles 5368361, California 5332921 90095

Community Clinical Trials
Orange 5379513, California 5332921 92868

Zuckerberg San Francisco General Hospital
San Francisco 5391959, California 5332921 94110

University of California, San Francisco
San Francisco 5391959, California 5332921 94158

UC Health Oncology Research
Colorado Springs 5417598, Colorado 5417618 80909

Yale Cancer Center
New Haven 4839366, Connecticut 4831725 06519

Bay Pines Foundation Inc
Bay Pines 4146855, Florida 4155751 33744

Florida Cancer Specialists
Fort Myers 4155995, Florida 4155751 33901

University of Miami
Miami 4164138, Florida 4155751 33136

Cancer Specialists of North Florida
Saint Augustine 4170894, Florida 4155751 32086

Florida Cancer Specialists.
St. Petersburg 4171563, Florida 4155751 33705

Florida Cancer Specialists
West Palm Beach 4177887, Florida 4155751 33401

University Cancer & Blood Center, LLC
Athens 4180386, Georgia 4197000 30607

Summit Cancer Care PC
Savannah 4221552, Georgia 4197000 31405

Rush University Medical Center
Chicago 4887398, Illinois 4896861 60612-3244

University of Chicago Medical Center
Chicago 4887398, Illinois 4896861 60637

IU Health Ball Memorial Hospital
Muncie 4924006, Indiana 4921868 47303

Mission Cancer + Blood - IMMC
Waukee 4880981, Iowa 4862182 50263

Baptist Health Lexington
Lexington 4297983, Kentucky 6254925 40503

Norton Cancer Institute- Poplar
Louisville 4299276, Kentucky 6254925 40217

VA Shreveport Healthcare System
Shreveport 4341513, Louisiana 4331987 71101

New England Cancer Specialists
Scarborough 4977882, Maine 4971068 04074

Beth Israel Deaconess Medical Center
Boston 4930956, Massachusetts 6254926 02215

Dana Farber Cancer Institute
Boston 4930956, Massachusetts 6254926 02215

Dana Farber/Harvard Cancer Center (Foxborough)
Foxborough 4937222, Massachusetts 6254926 02035

Dana-Farber Cancer Institute
Methuen 4943828, Massachusetts 6254926 01844

University of Michigan
Ann Arbor 4984247, Michigan 5001836 48109-0934

Henry Ford Health System;Clinical Trials Office
Detroit 4990729, Michigan 5001836 48202

Cancer and Hematology Centers of Western Michigan
Grand Rapids 4994358, Michigan 5001836 49503

Nebraska Methodist Estabrook Cancer Center
Omaha 5074472, Nebraska 5073708 68114

Renown Regional Medical Center Hospital
Reno 5511077, Nevada 5509151 89502-1576

New York Cancer & Blood Specialists - New Hyde Park
New Hyde Park 5128514, New York 5128638 11042-1116

New York Cancer and Blood Specialists-Central Park Hematology & Oncology
New York 5128581, New York 5128638 10028

Mount SInai Medical Center
New York 5128581, New York 5128638 10029

Columbia University Medical Center
New York 5128581, New York 5128638 10032

North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
Shirley 5138022, New York 5128638 11967

New York Cancer & Blood Specialists
The Bronx 5110266, New York 5128638 10469

University of North Carolina At Chapel Hill
Chapel Hill 4460162, North Carolina 4482348 27514

East Carolina University
Greenville 4469160, North Carolina 4482348 27834

Firsthealth of The Carolinas
Pinehurst 4485272, North Carolina 4482348 28374

Ohio State University Comprehensive Cancer Center
Columbus 4509177, Ohio 5165418 43210

SCRI Mark H. Zangmeister Center
Columbus 4509177, Ohio 5165418 43219

Taylor Cancer Research Center
Maumee 5162137, Ohio 5165418 43537

Oncology Associates of Oregon, P.C
Eugene 5725846, Oregon 5744337 97401

Oregon Health & Science University
Portland 5746545, Oregon 5744337 97239

Fox Chase Cancer Center
Philadelphia 4560349, Pennsylvania 6254927 19111

Allegheny Cancer Center
Pittsburgh 5206379, Pennsylvania 6254927 15212

Gibbs Cancer Center & Research Institute
Spartanburg 4597200, South Carolina 4597040 29303

Avera Cancer Institute
Sioux Falls 5231851, South Dakota 5769223 57105

Tennessee Oncology, PLLC - Chattanooga
Chattanooga 4612862, Tennessee 4662168 37404

Baptist Clinical Research Institute
Memphis 4641239, Tennessee 4662168 38120

Tennessee Oncology
Nashville 4644585, Tennessee 4662168 37203

JPS Health Network
Fort Worth 4691930, Texas 4736286 76104

MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030

Texas Oncology - Northeast Texas
Longview 4707814, Texas 4736286 75601

Virginia Commonwealth University - Massey Cancer Center
Richmond 4781708, Virginia 6254928 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.