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NCT06497556 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Non-Small Cell Lung Cancer and KRAS G12C Lung Cancer, sponsored by Hoffmann-La Roche.
- Active
- Registry status
- Phase 3
- Development phase
- 338
- Enrollment target
- 20
- Study locations
NCT06497556: Active Phase 3 study of Non-Small Cell Lung Cancer and KRAS G12C Lung Cancer, sponsored by Hoffmann-La Roche.
NCT06497556 is a Phase 3 study of Non-Small Cell Lung Cancer and KRAS G12C Lung Cancer that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 338 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (48% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06497556, a Phase 3 study of Non-Small Cell Lung Cancer and KRAS G12C Lung Cancer, is active but no longer recruiting, sponsored by Hoffmann-La Roche.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 338 participants
- Enrollment target
- 20
- Study locations
Study Summary
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).
Primary Outcome
PFS is defined as the time from randomization to the first occurrence of disease progression, as determined by blinded independent central review (BICR) according to RECIST v1.1, or death from any cause (whichever occurs first)
Conditions Studied
Interventions
- DRUG Divarasib
- DRUG Adagrasib
- DRUG Sotorasib
Study Locations (20)
California
- Los Angeles Cancer Network - Los Angeles
- UCLA Hematology / Oncology Clinic - Los Angeles
- University of California, San Francisco - San Francisco
Florida
- University of Miami - Miami
- Florida Cancer Specialists - North;725 6th Ave South (St. Petersburg) - St. Petersburg
Michigan
- University of Michigan - Ann Arbor
- Cancer and Hematology Centers of Western Michigan - Grand Rapids
Oregon
- Oncology Associates of Oregon, P.C - Eugene
- Oregon Health & Science University - Portland
Pennsylvania
- Fox Chase Cancer Center - Philadelphia
- Allegheny Cancer Center - Pittsburgh
Arizona
- Banner Health MD Anderson AZ - Gilbert
Connecticut
- Yale Cancer Center - New Haven
Illinois
- University of Chicago Medical Center - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 338 participants |
| Start Date | 2024-09-23 |
| Est. Completion | 2029-11-30 |
| Phase | Phase 3 |
What the registry record for NCT06497556 still lists
NCT06497556 is an interventional study that assigns participants to a tested intervention. The registered 338 participants enrollment target is mid-sized for trials with a published cap, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (48% lower).
The record links to 2 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which Divarasib is the first listed.
NCT06497556 names 20 study sites across 14 states, led by California, Florida, Michigan.
Frequently Asked Questions
What is clinical trial NCT06497556 about?
NCT06497556 is a clinical study titled "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". 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).
What is the current status of trial NCT06497556?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 338 participants. The study started on 2024-09-23. Estimated completion is 2029-11-30.
What conditions does trial NCT06497556 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, KRAS G12C Lung Cancer.
What interventions are being tested in trial NCT06497556?
The interventions under investigation include: Divarasib (DRUG), Adagrasib (DRUG), Sotorasib (DRUG).
Who is sponsoring clinical trial NCT06497556?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06497556 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT06497556's enrollment target sits among peer trials
338 111th of 454 higher than 344 of 454 other Non-Small Cell Lung Cancer trials
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