Divarasib for Non-Small Cell Lung Cancer
(KRASCENDO 3 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called divarasib for individuals with KRAS G12C-positive non-small cell lung cancer (NSCLC). The researchers aim to determine if divarasib outperforms current options, such as pembrolizumab, nivolumab, or observation after surgery. The trial seeks participants who have undergone surgery to remove lung cancer but did not achieve a complete response to pre-surgery chemotherapy combined with immunotherapy. Suitable candidates include those with NSCLC who have had surgery and a confirmed KRAS G12C mutation in their cancer. As a Phase 3 trial, this study serves as the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that divarasib is generally well-tolerated by patients with KRAS G12C-positive non-small cell lung cancer. In an earlier study, 61 out of 65 patients experienced at least one treatment-related side effect, but only 11 faced severe side effects. Importantly, no life-threatening side effects occurred. Other studies confirm divarasib's consistent safety record, with no new safety concerns identified in recent trials. This suggests that while divarasib is manageable for most people, it still carries some risks.12345
Why do researchers think this study treatment might be promising for non-small cell lung cancer?
Divarasib is unique because it specifically targets certain genetic mutations in non-small cell lung cancer (NSCLC) that current treatments may not address as effectively. Unlike standard immunotherapies like pembrolizumab or nivolumab, which stimulate the immune system to fight cancer, Divarasib directly inhibits the abnormal proteins driving cancer growth. This targeted approach could offer a more precise treatment, potentially leading to better outcomes for patients with these specific mutations. Researchers are excited because Divarasib's novel mechanism of action might provide an option for patients who do not respond well to existing therapies.
What evidence suggests that this trial's treatments could be effective for non-small cell lung cancer?
Research has shown that divarasib, which participants in this trial may receive, is a promising treatment for non-small cell lung cancer (NSCLC) with a specific KRAS mutation. In one study, divarasib shrank tumors in over half of the patients, achieving a 52% response rate. Additionally, 89% of patients had their disease well-managed, meaning the cancer remained under control. On average, patients lived about 13.1 months without their cancer worsening. These results suggest that divarasib could be an effective option for treating this type of lung cancer.12567
Who Is on the Research Team?
Clinical Trials
Principal Investigator
Hoffmann-La Roche
Are You a Good Fit for This Trial?
This trial is for people with stage II-IIIB non-small cell lung cancer (NSCLC) who have a KRAS G12C mutation, had their tumor surgically removed, received chemoimmunotherapy before surgery, and show no signs of the cancer coming back. Participants must be in good physical condition and join within 12 weeks after surgery.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive divarasib orally once daily for up to 52 cycles, or receive pembrolizumab, nivolumab, or undergo observation
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Divarasib
- Nivolumab
- Pembrolizumab
Trial Overview
The study compares a new drug called divarasib to either standard immunotherapy (pembrolizumab or nivolumab) or just observation. Patients are randomly assigned to one of these groups after their lung cancer surgery.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will receive divarasib, orally (PO), once daily (QD) for up to 52 cycles (1 cycle = 21 days).
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hoffmann-La Roche
Lead Sponsor
Dr. Levi Garraway
Hoffmann-La Roche
Chief Medical Officer since 2019
MD from the University of Basel
Dr. Thomas Schinecker
Hoffmann-La Roche
Chief Executive Officer since 2023
PhD in Molecular Biology from New York University
Citations
Single-Agent Divarasib in Patients With <i>KRAS G12C</i>
The median progression-free survival was 13.8 months (95% CI, 9.8 to 25.4) in the overall population (N = 65) and 15.3 months (95% CI, 12.3 to ...
Press Releases | Genentech's divarasib shows superiority ...
Genentech's Divarasib Shows Superiority in Head-to-Head Phase III Trial Against Approved KRAS G12C Inhibitors in Non-Small Cell Lung Cancer ...
Targeting KRAS G12C in non-small cell lung cancer
Efficacy outcomes in the overall population included an ORR of 27%, a DCR of 76% (95% CI, 53–92), and a mPFS of 8 months (95% CI, 4–NE). Among the 30 patients ...
4.
genentech-clinicaltrials.com
genentech-clinicaltrials.com/en/trials/cancer/lung-cancer/a-study-evaluating-the-efficacy-and-safety-of-divarasib-87627.htmlA study to compare divarasib with sotorasib or adagrasib in ...
A study to compare divarasib with sotorasib or adagrasib in people with KRAS G12C-positive non-small cell lung cancer that has previously been treated and ...
Divarasib in the Evolving Landscape of KRAS G12C Inhibitors ...
Divarasib has demonstrated efficacy in KRAS G12C-mutated NSCLC with ORR 53.4% and PFS 13.1 months. Although adverse events were frequent (93%), ...
[Ad hoc announcement pursuant to Art. 53 LR] Roche's ...
Divarasib showed clinically meaningful improvements in progression-free survival compared to approved KRAS G12C inhibitors; no new safety ...
Single-Agent Divarasib in Patients With KRAS G12C- ...
The median progression-free survival was 13.8 months (95% CI, 9.8 to 25.4) in the overall population (N = 65) and 15.3 months (95% CI, 12.3 to ...
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