400 Participants NeededMy employer runs this trial

Divarasib for Non-Small Cell Lung Cancer

(KRASCENDO 3 Trial)

Recruiting at 18 trial locations
RS
Fr
RS
Fr
Overseen ByFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Hoffmann-La Roche
Must be taking: Immune checkpoint inhibitors
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human 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?

CT

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

I am fully active or restricted in physically strenuous activity only.
I have had all of my lung cancer surgically removed.
I have received pembrolizumab or nivolumab with platinum-based chemotherapy before surgery.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive divarasib orally once daily for up to 52 cycles, or receive pembrolizumab, nivolumab, or undergo observation

Up to 156 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

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

Group I: DivarasibExperimental Treatment1 Intervention
Group II: Control: Pembrolizumab or Nivolumab or ObservationActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials
2,482
Recruited
1,107,000+
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Avastin, Herceptin, Rituxan, Accu-Chek
Dr. Levi Garraway profile image

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker profile image

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 ...

A 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 ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40632992/

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 ...