Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study on the Safety and Effects of Divarasib with Pembrolizumab and a Drug Combination for Patients with Advanced or Metastatic Non-Small Cell Lung Cancer with KRAS G12C Mutation

Fast replyRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of lung cancer known as Non-Small Cell Lung Cancer (NSCLC) that has a specific genetic change called the KRAS G12C mutation. The study is testing a new treatment called Divarasib, which is being used in combination with other cancer treatments. In one part of the study, Divarasib is combined with Pembrolizumab, a medication that helps the immune system fight cancer. In another part, Divarasib is combined with Pembrolizumab and a type of chemotherapy that includes Platinum-based drugs and Pemetrexed.

The purpose of the study is to evaluate how safe and tolerable these combinations are for patients who have not received any previous treatment for their advanced or metastatic NSCLC. The study will involve regular visits where participants will receive the treatments and be monitored for any side effects. The study will also look at how the cancer responds to the treatment and how long the response lasts. Participants will be asked about any symptoms they experience and how these affect their daily lives.

The study is expected to continue until 2026, with participants being closely monitored throughout the process. The information gathered will help determine the best dose of Divarasib when used with Pembrolizumab and the chemotherapy combination. This research aims to find more effective treatment options for patients with this specific type of lung cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and performing necessary tests to ensure the presence of the KRAS G12C mutation and PD-L1 expression, if applicable.

  2. Step 2

    Treatment initiation

    The treatment phase begins with the administration of medications. Depending on the assigned cohort, the treatment may include a combination of divarasib, pembrolizumab, and platinum-based chemotherapy with pemetrexed.

    For divarasib, the form is a film-coated tablet taken orally. The specific dosage and frequency are determined by the study protocol.

    For pembrolizumab, the form is a solution for infusion administered intravenously. The dosage is 25 mg/mL, and the frequency is determined by the study protocol.

    Platinum-based chemotherapy may involve cisplatin or carboplatin, both administered as solutions for infusion intravenously. The specific dosage and frequency are determined by the study protocol.

    The pemetrexed is also administered as a solution for infusion intravenously, with a concentration of 25 mg/mL. The specific dosage and frequency are determined by the study protocol.

  3. Step 3

    Ongoing monitoring

    Throughout the trial, regular monitoring is conducted to assess safety and response to treatment. This includes tracking any side effects and changes in health status.

    Participants may be required to attend scheduled visits for assessments, which include physical examinations, blood tests, and imaging studies.

  4. Step 4

    Evaluation of outcomes

    The primary outcomes evaluated include the occurrence of adverse events and changes in safety parameters from baseline.

    Secondary outcomes include the objective response rate, duration of response, progression-free survival, and the impact of treatment on daily function and quality of life.

  5. Step 5

    Completion of trial

    The trial is estimated to conclude by July 30, 2026. Upon completion, participants may undergo a final assessment to evaluate the overall impact of the treatment.

Who can join the trial?

9 criteria

  • The patient must have a type of lung cancer called non-squamous non-small cell lung cancer (NSCLC) that is advanced and cannot be removed by surgery.
  • The patient should not have received any previous treatment for their advanced lung cancer.
  • The patient must have a specific genetic change called the KRAS G12C mutation, which can be confirmed through tests on tissue or blood samples.
  • For some patients, the cancer cells must show a certain level of a protein called PD-L1. This is not required for all patients, but it is necessary for some groups in the study.
  • The patient must provide a sample of their tumor tissue, which is a small piece of the cancer, for testing. This sample should be prepared in a specific way, either as a block or as slides.
  • The patient must have a good general health status, which is measured by a scale called the Eastern Cooperative Oncology Group (ECOG) performance status. The patient should have a score of 0 or 1, indicating they are fully active or have some symptoms but can still do light work.
  • The patient must have cancer that can be measured using specific criteria known as Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  • The study is open to both male and female patients.
  • The study includes patients who are considered vulnerable, meaning they may need extra care or protection.

Who cannot join the trial?

4 criteria

  • Patients who have not received treatment for their advanced or metastatic non-small cell lung cancer cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who belong to a clinical trial group that is not included in this study cannot participate.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Divarasib

    is an investigational medication being studied for its potential to treat advanced or metastatic non-small cell lung cancer. It is specifically being tested in patients whose cancer has a KRAS G12C mutation. The role of divarasib in the trial is to assess its safety and how well it works when used with other cancer treatments.

  • Pembrolizumab

    is a medication used in cancer treatment that helps the immune system recognize and attack cancer cells. In this trial, it is being combined with divarasib to see if the combination is safe and effective for patients with a specific type of lung cancer.

  • Platinum-based chemotherapy

    refers to a group of cancer treatments that contain the metal platinum. These medications work by damaging the DNA of cancer cells, which can stop them from growing and dividing. In this study, platinum-based chemotherapy is used alongside divarasib and pembrolizumab to evaluate the combined effect on lung cancer.

  • Pemetrexed

    is a chemotherapy drug that interferes with the growth of cancer cells. It is used in combination with other treatments in this trial to determine if it enhances the effectiveness of the therapy for patients with advanced lung cancer.

What is already known about the treatment

  • Divarasib

    This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating advanced or metastatic non-small cell lung cancer with a specific KRAS G12C mutation. It is not yet widely used in standard medical practice, as it is still under investigation. The main therapeutic indication is for patients with untreated advanced or metastatic non-small cell lung cancer. Divarasib works by specifically targeting and inhibiting the KRAS G12C mutation, which is a common driver of cancer cell growth in this type of lung cancer. It is classified as a targeted cancer therapy.

  • Pembrolizumab

    This medication is administered intravenously and is an established treatment in oncology, particularly for various types of cancer, including lung cancer. It is used in combination with divarasib in clinical trials to enhance treatment efficacy for patients with advanced or metastatic non-small cell lung cancer. Pembrolizumab is an immune checkpoint inhibitor that works by blocking the PD-1 pathway, thereby boosting the immune system's ability to attack cancer cells. It is classified as an immunotherapy.

  • Platinum-based chemotherapy

    This class of chemotherapy drugs is administered intravenously and is a standard treatment for various cancers, including lung cancer. In the clinical trial, it is used in combination with divarasib and pembrolizumab to treat advanced or metastatic non-small cell lung cancer. These drugs work by damaging the DNA of cancer cells, preventing them from dividing and growing. They are classified as cytotoxic chemotherapy agents.

  • Pemetrexed

    This medication is administered intravenously and is commonly used in combination with other chemotherapy drugs to treat non-small cell lung cancer. In the clinical trial, it is combined with divarasib, pembrolizumab, and platinum-based chemotherapy. Pemetrexed works by interfering with the cancer cell's ability to replicate its DNA, thus inhibiting cell growth. It is classified as an antimetabolite chemotherapy agent.

Investigated diseases

Non-Small Cell Lung Cancer – This is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of cases. The disease typically begins in the tissues of the lungs and can spread to other parts of the body if not treated. Symptoms may include a persistent cough, chest pain, and shortness of breath. As the disease progresses, it may lead to more severe respiratory issues and other systemic symptoms. Early detection is crucial for managing the disease effectively.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-507171-22-00Protocol codeBO44426Estimated enrolment240 patientsSponsorF. Hoffmann-La Roche AG

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).