ACTIVE_NOT_RECRUITING

A Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Participants With Previously Treated KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer

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Conditions

Non-Small Cell Lung CancerKRAS G12C Lung CancerAdvanced Non-Small Cell Lung CancerKRAS G12 Lung CancerAdvanced Lung CancerMetastatic lung cancerDivarasibKRAS G12C InhibitorKRAS G12C PositiveKRAS MutationKRAS G12C MutationLung Cancer Mutation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2024-09-23
Study Completion:2029-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06497556

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Unequivocal histologically or cytologically confirmed diagnosis of metastatic or locally advanced NSCLC not amenable to treatment with surgical resection or combined chemoradiation
  2. * 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
  3. * Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  4. * Documentation of the presence of a KRAS G12C mutation
  5. * 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
  6. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  7. * Life expectancy of \>= 12 weeks
  1. * Known hypersensitivity to any of the components of divarasib, or sotorasib or adagrasib
  2. * Malabsorption syndrome or other condition that would interfere with enteral absorption
  3. * Known concomitant second oncogenic driver
  4. * Mixed small-cell lung cancer or large cell neuroendocrine histology
  5. * Known and untreated, or active central nervous system (CNS) metastases
  6. * Leptomeningeal disease or carcinomatous meningitis
  7. * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures biweekly or more frequently
  8. * 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
  9. * Prior treatment with any KRAS G12C inhibitor or pan-KRAS/RAS inhibitor
  10. * More than 30 Gy of radiotherapy to the lung within 6 months of randomization
  11. * Uncontrolled tumor-related pain
  12. * Unresolved toxicities from prior anticancer therapy
  13. * 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

Contacts and Locations

Principal Investigator

Clinical Trials
STUDY_DIRECTOR
Hoffmann-La Roche

Study Locations (Sites)

Banner Health MD Anderson AZ
Gilbert, Arizona, 85234
United States
Banner Health MD Anderson AZ
Phoenix, Arizona, 85006
United States
University of Arkansas For Medical Sciences
Little Rock, Arkansas, 72205
United States
Los Angeles Cancer Network
Los Angeles, California, 90017-4803
United States
UCLA Hematology / Oncology Clinic
Los Angeles, California, 90095
United States
Community Clinical Trials
Orange, California, 92868
United States
Zuckerberg San Francisco General Hospital
San Francisco, California, 94110
United States
University of California, San Francisco
San Francisco, California, 94158
United States
UC Health Oncology Research
Colorado Springs, Colorado, 80909
United States
Yale Cancer Center
New Haven, Connecticut, 06519
United States
Bay Pines Foundation Inc
Bay Pines, Florida, 33744
United States
Florida Cancer Specialists
Fort Myers, Florida, 33901
United States
University of Miami
Miami, Florida, 33136
United States
Florida Cancer Specialists.
St. Petersburg, Florida, 33705
United States
Florida Cancer Specialists
West Palm Beach, Florida, 33401
United States
University Cancer & Blood Center, LLC
Athens, Georgia, 30607
United States
Summit Cancer Care PC
Savannah, Georgia, 31405
United States
Rush University Medical Center
Chicago, Illinois, 60612-3244
United States
University of Chicago Medical Center
Chicago, Illinois, 60637
United States
Baptist Health Lexington
Lexington, Kentucky, 40503
United States
Norton Cancer Institute- Poplar
Louisville, Kentucky, 40217
United States
New England Cancer Specialists
Westbrook, Maine, 04092
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Dana Farber/Harvard Cancer Center (Foxborough)
Foxborough, Massachusetts, 02035
United States
Dana-Farber Cancer Institute
Methuen, Massachusetts, 01844
United States
University of Michigan
Ann Arbor, Michigan, 48109-0934
United States
Henry Ford Health System;Clinical Trials Office
Detroit, Michigan, 48202
United States
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49503
United States
Minnesota Oncology Edina
Edina, Minnesota, 55435
United States
Renown Regional Medical Center Hospital
Reno, Nevada, 89502
United States
New York Cancer & Blood Specialists - New Hyde Park
New Hyde Park, New York, 11042-1116
United States
New York Cancer and Blood Specialists-Central Park Hematology & Oncology
New York, New York, 10028
United States
Columbia University Medical Center
New York, New York, 10032
United States
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
Shirley, New York, 11967
United States
New York Cancer & Blood Specialists
The Bronx, New York, 10469
United States
University of North Carolina At Chapel Hill
Chapel Hill, North Carolina, 27514
United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
United States
Taylor Cancer Research Center
Maumee, Ohio, 43537
United States
Oncology Associates of Oregon, P.C
Eugene, Oregon, 97401
United States
Oregon Health & Science University
Portland, Oregon, 97239
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Allegheny Cancer Center
Pittsburgh, Pennsylvania, 15212
United States
Gibbs Cancer Center & Research Institute
Spartanburg, South Carolina, 29303
United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
United States
Tennessee Oncology, PLLC - Chattanooga
Chattanooga, Tennessee, 37404
United States
Baptist Clinical Research Institute
Memphis, Tennessee, 38120
United States
Tennessee Oncology
Nashville, Tennessee, 37203
United States
JPS Health Network
Fort Worth, Texas, 76104
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States
Texas Oncology - Northeast Texas
Longview, Texas, 75601
United States
Virginia Commonwealth University - Massey Cancer Center
Richmond, Virginia, 23298-0042
United States

Collaborators and Investigators

Sponsor: Hoffmann-La Roche

  • Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-23
Study Completion Date2029-11-30

Study Record Updates

Study Start Date2024-09-23
Study Completion Date2029-11-30

Terms related to this study

Keywords Provided by Researchers

  • Advanced Non-Small Cell Lung Cancer
  • KRAS G12 Lung Cancer
  • Advanced Lung Cancer
  • Metastatic lung cancer
  • Divarasib
  • KRAS G12C Inhibitor
  • KRAS G12C Positive
  • KRAS Mutation
  • KRAS G12C Mutation
  • Lung Cancer Mutation

Additional Relevant MeSH Terms

  • Non-Small Cell Lung Cancer
  • KRAS G12C Lung Cancer