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Study on Pembrolizumab and Chemotherapy with Radiation for Advanced Non-Small Cell Lung Cancer Patients

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What is this study about?

This clinical trial is focused on studying treatments for advanced stages of non-small cell lung cancer (NSCLC), which is a type of lung cancer. The study involves the use of several medications, including pembrolizumab, a type of drug known as a PD-1 inhibitor that helps the immune system fight cancer cells. Other medications used in the study are paclitaxel, paclitaxel albumin-bound, pemetrexed, cisplatin, and carboplatin. These drugs are types of chemotherapy, which work by stopping the growth of cancer cells. The purpose of the study is to compare the survival rates of patients receiving a combination of these treatments with and without the addition of radiation therapy.

Participants in the study will receive their treatments through an intravenous (IV) infusion, which means the medication is given directly into a vein. The study will take place over a period of time, with treatments being administered in cycles. Each cycle lasts for 21 days, and the total number of cycles will depend on the specific treatment plan for each participant. Some participants will also receive radiation therapy, which uses high-energy rays to target and kill cancer cells in specific areas of the body.

The study aims to understand how well these treatment combinations work in improving the overall survival of patients with advanced NSCLC. It will also look at the side effects of the treatments and how they affect the quality of life of the participants. The results will help determine the best treatment approach for patients with this type of lung cancer. Participants will be monitored closely throughout the study to ensure their safety and to gather information on the effectiveness of the treatments.

1 initial treatment phase

Upon joining the study, the patient will begin treatment with a combination of medications administered through an intravenous route. The medications include pembrolizumab, a PD-1 inhibitor, and chemotherapy drugs such as paclitaxel albumin-bound, pemetrexed, cisplatin, carboplatin, and paclitaxel.

The specific combination of chemotherapy drugs will depend on the type of non-small cell lung cancer (NSCLC) the patient has. For squamous NSCLC, the treatment will include carboplatin with either paclitaxel or paclitaxel albumin-bound. For non-squamous NSCLC without specific mutations, the treatment will include pemetrexed and a platinum-based chemotherapy.

2 concurrent radiation therapy

In addition to the medication regimen, the patient will receive radiation therapy targeted at the tumor sites. This will be done using either three-dimensional conventional radiotherapy (3D-CRT) or stereotactic ablative radiotherapy (SABR), depending on the specific characteristics of the tumor and surrounding organs.

3 monitoring and follow-up

Throughout the trial, the patient’s health and response to treatment will be closely monitored. This includes regular visits for examinations and assessments of tumor response using imaging techniques.

The patient’s overall survival, progression-free survival, and quality of life will be evaluated at various intervals, with specific attention to any side effects or adverse events experienced during the trial.

4 end of trial evaluation

At the conclusion of the trial, the patient’s overall survival rate will be assessed, with a report of the one-year survival rate. Additional evaluations will include the assessment of tumor response and any long-term effects of the treatment.

Who Can Join the Study?

  • The patient must have signed a written informed consent form before any study-specific procedures.
  • Women who can have children and male patients must agree to use proper birth control during the study and for up to 6 months after finishing treatment.
  • The patient must be part of the social security system or an equivalent system.
  • The patient must be willing and able to follow the study rules, including attending treatment sessions, scheduled visits, and examinations, as well as follow-up.
  • The patient must have a confirmed diagnosis of advanced (stage IIIB/IIIC/IV) non-small cell lung cancer (NSCLC), which can be either squamous or non-squamous.
  • The patient must be eligible for treatment with pembrolizumab and chemotherapy according to European guidelines. For squamous NSCLC, this includes using carboplatin with either paclitaxel or nab-paclitaxel. For non-squamous NSCLC without specific genetic mutations (EGFR or ALK), this includes using pemetrexed with a platinum-based chemotherapy.
  • The patient must be 18 years of age or older.
  • The patient must have an ECOG performance status of 0 to 1, which means they are fully active or have some symptoms but can still do light work.
  • The patient must have a life expectancy of more than 3 months.
  • The patient must have a measurable lesion, which is a tumor that can be measured, as assessed by specific guidelines (RECIST version 1.1).
  • The patient’s metastases or primary tumor must be suitable for certain types of radiotherapy, which are treatments using radiation, based on specific safety guidelines.
  • The patient must have adequate organ function, shown by specific laboratory test results within 14 days before starting the study treatment. This includes:
    • An absolute neutrophil count of at least 1,500 cells per cubic millimeter.
    • Platelets of at least 100,000 per cubic millimeter.
    • Hemoglobin greater than 9 grams per deciliter (transfusions are allowed).
    • Creatinine clearance greater than 60 milliliters per minute, which measures kidney function.
    • Bilirubin levels no more than 1.5 times the upper limit of normal (ULN), unless the patient has Gilbert’s syndrome, where up to 3 times ULN is allowed.
    • Serum ALT and AST levels no more than 2.5 times ULN, unless there is liver metastasis, where up to 5 times ULN is allowed. These are liver enzymes.
    • ALP levels no more than 2.5 times ULN, unless there is bone or liver metastasis, where up to 5 times ULN is allowed. ALP is another liver enzyme.
    • INR, PT, and PTT levels no more than 1.5 times ULN, unless the patient is on blood-thinning medication. These are tests related to blood clotting.

Who Cannot Join the Study?

  • Patients who have a different type of cancer than the one being studied.
  • Patients who have already received treatment for their cancer that is not allowed in the study.
  • Patients with serious health conditions that could make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures for any reason.
  • Patients who have an allergy to any of the study medications.
  • Patients who are participating in another clinical trial at the same time.
  • Patients who have had a recent infection that could affect their participation.
  • Patients with a history of certain heart conditions that could be worsened by the study treatment.
  • Patients who have a history of drug or alcohol abuse that could interfere with the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse France
Centr Georges Francois Leclerc Dijon France
Centre Jean Perrin Clermont Ferrand France
Centre Hospitalier Intercommunal Creteil Creteil France
Comite Entreprise Paul Papin Angers France

Other Sites

Site Name City Country Status
Centre Antoine Lacassagne Nice France
Centre Hospitalier Universitaire De Nimes Nimes France
Centre De Cancerologue Du Grand Montpellier Montpellier France
Institut Sainte Catherine Avignon France
Hopital Europeen Marseille Marseille France
Polyclinique De Limoges Limoges France
Centre Henri Becquerel Rouen France
Centre Hospitalier De Cannes Simone Veil Cannes France
Centre Paul Strauss STRASBOURG, Alsace France
Centre Joliot Curie Saint-Martin-Boulogne France
Clinique Ambroise Pare Beuvry France
Scp Institut De Cancerologie Des Hauts De France Beuvry France
Hopital Prive Clairval Marseille France
Societe De Recherche Oncologique Clinique 37 Chambray Les Tours France
Centre Francois Baclesse Caen France
L’Hopital Alexandra Lepeve Dunkirk France
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Hlusqvh Pqycb Aiqeahz Tapkgv Mtgxkmg Sibosq Acgfqdgzb Mougins France
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Gtngfv Hfpsumuxkdk Uirdhohvsbppe Ppand Pxuuvzrggzz Ew Nouiyvvndark Paris France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
21.03.2019

Trial locations

Investigated drugs:

PD-1 Inhibitor: This medication is used to help the immune system recognize and attack cancer cells. It works by blocking a specific protein on the surface of immune cells, which can prevent the immune system from attacking the cancer. In this trial, it is being tested to see if it can improve survival rates in patients with advanced non-small cell lung cancer.

Chemotherapy: This treatment uses drugs to kill cancer cells or stop them from growing. It is a common treatment for many types of cancer, including non-small cell lung cancer. In this trial, chemotherapy is combined with other treatments to see if it can improve patient outcomes.

Radiotherapy: This therapy uses high-energy rays to target and destroy cancer cells. It is often used to treat tumors in specific areas of the body. In this trial, radiotherapy is being used alongside other treatments to determine if it can help improve survival rates in patients with advanced non-small cell lung cancer.

Investigated diseases:

Non-Small Cell Lung Cancer (NSCLC) – 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 all cases. NSCLC typically grows and spreads more slowly than small cell lung cancer. In advanced stages, such as IIIB, IIIC, or IV, the cancer has spread beyond the lungs to other parts of the body. The progression of NSCLC can vary, with some tumors growing slowly over time, while others may progress more rapidly. Treatment options often depend on the stage and specific characteristics of the cancer.

Trial ID:
2024-512173-27-00
Protocol code:
UC-0107/1718
Trial Phase:
Therapeutic confirmatory (Phase III)

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