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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-524263-21-00 | EU Trial (CTIS) Number |
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The main purpose of this study is to evaluate the efficacy of divarasib compared with investigator's choice of immunotherapy (pembrolizumab or nivolumab) or observation in participants with resected Kirsten rat sarcoma viral oncogene homolog glycine 12 to cysteine (KRAS G12C)-positive Stage II-IIIB NSCLC, regardless of tumor programmed death-ligand 1 (PD-L1) status, who have not achieved pathologic complete response (pCR) following neoadjuvant chemoimmunotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Divarasib | Experimental | Participants will receive divarasib, orally (PO), once daily (QD) for up to 52 cycles (1 cycle = 21 days). |
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| Control: Pembrolizumab or Nivolumab or Observation | Active Comparator | Participants will receive either pembrolizumab, nivolumab, or undergo observation, depending on the treatment received prior to surgery. No study treatment will be given to participants who will undergo observation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Divarasib | Drug | Divarasib will be administered orally as per the schedule specified in the respective arm. |
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| Measure | Description | Time Frame |
|---|---|---|
| Disease-free Survival (DFS), as Determined by the Investigator | From randomization to disease recurrence or death from any cause (Up to approximately 5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | From date of randomization to death from any cause (up to approximately 8 years) | |
| DFS Rates at 2 and 3 Years, as Assessed by the Investigator | At Year 2 and Year 3 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: BO45885 https://forpatients.roche.com/ No attachments to email below. | Contact | 888-662-6728 (U.S. only) | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
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| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
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For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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| Pembrolizumab | Drug | Pembrolizumab will be administered as either a 200 mg intravenous (IV) infusion, every 3 weeks (Q3W) or 395 mg subcutaneous (SC) injection Q3W, for up to 13 cycles (1 cycle = 21 days). |
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| Nivolumab | Drug | Nivolumab will be administered as either a 480 mg IV infusion, every 4 weeks (Q4W) or 1200 mg SC injection Q4W, for up to 13 cycles (1 cycle = 28 days). |
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| Number of Participants With Adverse Events (AEs) |
| From randomization to 60 days after the end of study treatment (up to approximately 8 years) |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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