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:2029-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status: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 unresectable Stage IIIc, per the American Joint Committee on Cancer staging system (AJCC) (Amin et al. 2017) not amenable to treatment with combined modality chemoradiation (advanced) or Stage IV (metastatic) NSCLC
  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 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

Study Contact

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

Principal Investigator

Clinical Trials
STUDY_DIRECTOR
Hoffmann-La Roche

Study Locations (Sites)

Banner Health MD Anderson AZ
Gilbert, Arizona, 85234
United States
Cancer Specialists of North Florida
Jacksonville, Florida, 32256
United States
New England Cancer Specialists
Scarborough, Maine, 04074
United States
Nebraska Methodist Estabrook Cancer Center
Omaha, Nebraska, 68114
United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
United States
Baptist Clinical Research Institute
Memphis, Tennessee, 38120
United States
MD Anderson Cancer Center
Houston, Texas, 77030
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 Date2029-09-30

Study Record Updates

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

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