Divarasib + Pembrolizumab for Non-Small Cell Lung Cancer
(KRAScendo 170 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment combination for individuals with advanced or metastatic non-small cell lung cancer (NSCLC), using two drugs: divarasib (GDC-6036) and pembrolizumab. The trial aims to assess the safety of this combination, how the body processes these drugs, and their effectiveness together. Participants will receive varying doses of divarasib combined with pembrolizumab, and some may also receive chemotherapy. This trial suits those diagnosed with advanced or metastatic NSCLC who have not yet undergone treatment. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new combination therapy.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that divarasib, when used alone, has a manageable safety profile, meaning most side effects can be effectively handled. In studies with 137 patients, including those with non-small cell lung cancer (NSCLC), divarasib was generally well-tolerated. Common side effects were mild, such as fatigue and nausea.
Pembrolizumab, another part of this study, is already approved for use in various cancers and has a well-known safety profile. Common side effects include fatigue, itching, and rash, while serious side effects are rare but possible.
The researchers aim to determine if combining divarasib with pembrolizumab works well without increasing side effects. So far, earlier findings suggest the combination is promising for safety. However, this study will provide a deeper understanding.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of divarasib and pembrolizumab for non-small cell lung cancer because it introduces a novel approach to treatment. Unlike existing therapies, which often rely on chemotherapy or targeted drugs aimed at specific mutations, divarasib targets the KRAS mutation, a common but challenging target in lung cancer. When combined with pembrolizumab, an immunotherapy drug that unleashes the body's immune system against cancer cells, this treatment has the potential to offer a more effective and personalized approach. This combination could enhance the immune response and improve outcomes beyond what current treatments achieve.
What evidence suggests that this trial's treatments could be effective for non-small cell lung cancer?
Research has shown that divarasib, when used alone, may help treat certain cancers, particularly those with a KRAS G12C mutation. This mutation often appears in non-small cell lung cancer (NSCLC). Divarasib specifically targets and blocks this mutation, potentially stopping cancer cell growth. Early studies indicate that it is generally safe and shows promise in shrinking tumors. In this trial, participants will receive divarasib combined with pembrolizumab, an immunotherapy that has already succeeded in treating NSCLC by helping the immune system fight cancer cells. Combining divarasib with pembrolizumab might enhance treatment effectiveness by attacking the cancer in different ways.23567
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 adults with advanced or metastatic non-small cell lung cancer (NSCLC) that hasn't been treated yet and has a specific mutation called KRAS G12C. Participants need to have measurable disease, be in good physical condition (ECOG 0 or 1), and provide tumor tissue samples. They can't join if they've had another cancer within the last 5 years, untreated brain metastases, uncontrolled symptoms from their cancer, prior treatment with KRAS G12C inhibitors, certain lung conditions, active infections like TB, or recent heart problems.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive divarasib in combination with pembrolizumab and potentially chemotherapy, with dose finding and expansion stages
Follow-up
Participants are monitored for safety, pharmacokinetics, and activity after treatment
What Are the Treatments Tested in This Trial?
Interventions
- GDC-6036
- Pembrolizumab
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