臨床研究等提出・公開システム

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

A Study to Evaluate the Efficacy and Safety of Divarasib Compared With Investigator's Choice of Immunotherapy or Observation in Participants With Resected Stage II-III KRAS G12C-Positive Non-Small Cell Lung Cancer (NSCLC) (KRASCENDO 3)

Raymond Meng

F. Hoffmann-La Roche

1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU,Tokyo

clinical-trials@chugai-pharm.co.jp

Clinical trials information

Chugai Pharmaceutical Co., Ltd.

1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU,Tokyo

+81-120189706

clinical-trials@chugai-pharm.co.jp

Pending

Oct. 01, 2026

Interventional

non-randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

1. ECOG Performance Status of 0 or 1
2. Histological or cytological diagnosis of clinical Stage II-IIIB NSCLC of either non-squamous or squamous histology
3. Participants must have had complete resection of NSCLC
4. Prior treatment with neoadjuvant immune checkpoint inhibitor (pembrolizumab or nivolumab) in combination with histology-based platinum-based doublet chemotherapy
5. Patients must be randomized within 12 weeks of their surgery date
6. No evidence of disease recurrence or metastatic disease
7. Documentation of the presence of a KRAS G12C mutation

1. Participants who achieve pCR following neoadjuvant treatment
2. Prior treatment with a KRAS inhibitor or any other anti-cancer therapy not otherwise specified in the protocol
3. Prior treatment with radiation therapy for NSCLC, with the exception of localized symptom-directed radiation prior to surgical resection
4. Resolved Grade 3 or greater immune-related adverse event or unresolved Grade 2 or greater immune-related adverse event from neoadjuvant immunotherapy
5. Active or history of autoimmune disease or immune deficiency
6. Significant cardiovascular disease

Both

KRAS G12C-positive Stage II-IIIB NSCLC

Divarasib:PO QD approximately 3 years
Pembrolizumab:IV Q3W, for up to 13 cycles
Nivolumab:IV Q4W, for up to 13 cycles

efficacy, confirmatory
Disease-free Survival (DFS), as determined by investigators.

safety, efficacy
Overall Survival (OS),
2-year and 3-year DFS rates as assessed by the investigator,
Number of Participants With Adverse Events (AEs)

Yes

Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).

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