Roche Initiates Phase III Clinical Trial of RO7435846 (Divarasib) in First-Line KRAS G12C-Mutated Non-Small Cell Lung Cancer

Data from the Drug Clinical Trial Registration and Information Disclosure Platform shows that a Phase III, randomized, open-label study evaluating the efficacy and safety of DIVARASIB in combination with pembrolizumab compared to pembrolizumab in combination with pemetrexed and carboplatin or cisplatin in previously untreated patients with advanced or metastatic non-squamous non-small cell lung cancer carrying the KRAS G12C mutation has been initiated by F. Hoffmann-La Roche Ltd / Roche (China) Investment Co., Ltd. / F. Hoffmann-La Roche AG; F. Hoffmann-La Roche AG / F. Hoffmann-La Roche AG. The clinical trial registration number is CTR20254061, with the initial information disclosure date on October 13, 2025.

The investigational drugs include GDC-6036 (Divarasib) tablets in 50 mg, 100 mg, 200 mg, and 400 mg strengths, administered at a dose of 400 mg QD; and pembrolizumab (Pembrolizumab) injection in 25 mg/mL, 100 mg strength, administered at a dose of 200 mg Q3W. The purpose of this trial is to evaluate the efficacy and safety of divarasib in combination with pembrolizumab compared to pembrolizumab combined with pemetrexed and carboplatin or cisplatin as first-line treatment for adult patients with advanced or metastatic non-squamous non-small cell lung cancer carrying the KRAS G12C mutation.

RO7435846 tablets are chemical drugs indicated for non-small cell lung cancer. Non-small cell lung cancer is the most common type of lung cancer, including adenocarcinoma, squamous cell carcinoma, etc. Symptoms include cough, hemoptysis, chest pain, etc., with diagnosis relying on imaging and histopathological biopsy. Treatment options include surgery, radiotherapy, chemotherapy, targeted therapy, etc.

The primary endpoint indicators of this trial include evaluating the effectiveness of divarasib combined with pembrolizumab compared to pembrolizumab combined with pemetrexed and carboplatin or cisplatin. The time intervals are from randomization to the time of disease progression or all-cause death (whichever occurs first) as determined by BICR according to RECIST v1.1, and from randomization to all-cause death. Secondary endpoint indicators include evaluating the effectiveness of the combination therapy (e.g., achieving CR or PR consecutively twice with an interval ≥4 weeks as determined by BICR according to RECIST v1.1), evaluating symptoms and functions from the participant's perspective, assessing safety and tolerability, and evaluating health-related quality of life from the participant’s perspective.

Currently, the trial status is ongoing (not yet recruiting), with a target enrollment of 78 participants in China and 660 participants internationally.

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