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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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy

Other Sites

Site Name City Country Status
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie Olsztyn Poland
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Algemeen Ziekenhuis Delta Roeselare Belgium
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Virgen del Rocío University Hospital Sevilla Spain
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Jessa Ziekenhuis Hasselt Belgium
Netherlands Cancer Institute Amsterdam The Netherlands
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Cbuiojesh Ukurrolbhdhjmh Swzcsuvsd Woluwe-Saint-Lambert Belgium
Siqyezotj Rfxmphf Uzljavjrnc Msasfzy Cruxyt Nijmegen The Netherlands
Uqsziobgxqfimu Cgtkbfv Kcxukbakm Gdansk Poland
Hmjrvhza Uoyeoorvyebxk Hxdobhux Tjtew y Poietg Ievvkdwr Cfdzfz dppfznljuwsyykmfp (bskw Badalona Spain
Hgofenho Vpqh degfzubk Barcelona Spain
Kogcfufhl Spwzpis Sreqincahadwevz ia Jnmv Paffe In Cracow Poland
Ikeqydlz Rjenvjwwa Pxg Lx Signmn Dex Tyizhz Doib Awouyps Igfj Stqswr Meldola Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
15.08.2023
Italy Italy
Recruiting
15.08.2023
Poland Poland
Recruiting
15.08.2023
Spain Spain
Recruiting
15.08.2023
Sweden Sweden
Recruiting
15.08.2023
The Netherlands The Netherlands
Recruiting
15.08.2023

Trial locations

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.

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 ID:
2023-507171-22-00
Protocol code:
BO44426
Trial Phase:
Human Pharmacology (Phase I) – Other

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