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A PHASE III, RANDOMIZED, OPEN-LABEL STUDY EVALUATING THE EFFICACY AND SAFETY OF DIVARASIB COMPARED WITH INVESTIGATOR’S CHOICE OF IMMUNOTHERAPY OR OBSERVATION IN PATIENTS WITH RESECTED STAGE II-III KRAS G12C-POSITIVE NON-SMALL CELL LUNG CANCER

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-524263-21-01
Enrollment
80
Registered
2026-08-28
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Resected Stage II-III Kirsten rat sarcoma virus oncogene homolog glycine 12 to Cysteine (KRAS G12C) -Positive Non-Small Cell Lung Cancer

Brief summary

DFS defined as the time from randomization to the first documented recurrence of disease or new primary NSCLC as determined by the investigator through use of an integrated assessment of radiographic data, biopsy sample results (if clinically feasible), and clinical status or death from any cause, whichever occurs first

Detailed description

Overall Survival (OS) defined as the time from randomization to death from any cause, 2-year and 3-year DFS rates as assessed by the investigator, Incidence and severity of adverse events, including, but not limited to treatment emergent adverse events, serious adverse events, and deaths

Interventions

DRUGNIVOLUMAB
DRUGPEMBROLIZUMAB

Sponsors

F. Hoffmann-La Roche AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
DFS defined as the time from randomization to the first documented recurrence of disease or new primary NSCLC as determined by the investigator through use of an integrated assessment of radiographic data, biopsy sample results (if clinically feasible), and clinical status or death from any cause, whichever occurs first

Secondary

MeasureTime frame
Overall Survival (OS) defined as the time from randomization to death from any cause, 2-year and 3-year DFS rates as assessed by the investigator, Incidence and severity of adverse events, including, but not limited to treatment emergent adverse events, serious adverse events, and deaths

Outcome results

None listed

Source: EU CTIS · Data processed: Aug 29, 2026