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Study Comparing Dostarlimab and Pembrolizumab with Chemotherapy for Patients with Metastatic Non-Small Cell Lung Cancer

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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), specifically the non-squamous subtype. The study aims to compare the effectiveness of two different treatments. One treatment involves the drug Dostarlimab combined with chemotherapy, while the other uses Pembrolizumab with chemotherapy. Both treatments are administered through an intravenous infusion, which means they are given directly into a vein.

The purpose of the study is to evaluate how well these treatments work in patients with metastatic non-squamous NSCLC, which means the cancer has spread to other parts of the body. Participants in the study will receive one of the two treatment combinations. The study will last for a period of up to 105 weeks, during which the participants will be monitored regularly to assess the response of their cancer to the treatment. The study will also look at the overall survival of participants and the time it takes for the cancer to progress or worsen.

Throughout the study, participants will undergo various health assessments, including blood tests and physical exams, to ensure their safety and to monitor any side effects. The study will also collect information on any adverse events, which are any unwanted effects that occur during the treatment period. This information will help researchers understand the safety and effectiveness of the treatments being studied.

1 joining the study

Upon joining the study, the participant will be randomly assigned to one of two treatment groups. This process is called randomization and ensures that each participant has an equal chance of receiving either treatment option.

2 treatment administration

Participants will receive either dostarlimab or pembrolizumab in combination with chemotherapy. The specific chemotherapy drugs used are pemetrexed, carboplatin, or cisplatin.

All medications will be administered through an intravenous infusion, which means they will be given directly into a vein through a needle or tube.

The dosage and frequency of administration will be determined by the study protocol and the healthcare team overseeing the trial.

3 monitoring and assessments

Throughout the trial, participants will undergo regular monitoring to assess their response to the treatment. This includes physical examinations, blood tests, and imaging studies such as CT scans.

The primary goal is to evaluate the overall response rate (ORR) to the treatment, which measures how well the cancer responds to the therapy.

4 safety evaluations

Participants will be closely monitored for any side effects or adverse events. This includes tracking any new symptoms or changes in health status.

Safety evaluations will continue for up to 90 days after the last dose of the study treatment to ensure participant well-being.

5 completion of the study

The study is expected to conclude by October 29, 2025. Participants will be informed about the results and any further steps if necessary.

Upon completion, participants may have follow-up visits to monitor their health and discuss any ongoing care needs.

Who Can Join the Study?

  • The participant must be at least 18 years old, able to understand the study procedures, and agree to participate by signing a written consent form.
  • The participant must have a confirmed diagnosis of metastatic non-squamous non-small cell lung cancer (NSCLC), which means the cancer has spread beyond the lungs and is not of the squamous cell type. The cancer should not have specific genetic changes (mutations) for which targeted treatments are available.
  • The participant must have at least one measurable tumor, which means a tumor that can be measured in size using medical imaging. If the tumor was previously treated with radiation and has grown again, it can be considered measurable.
  • The participant must have a documented PD-L1 status, which is a test to see if the cancer cells have a certain protein that might affect treatment options.
  • The participant must have an ECOG performance status score of 0 or 1, which means they are fully active or have some symptoms but can still carry out light work.
  • The participant must have a life expectancy of at least 3 months.
  • The participant must have adequate organ function, which means their organs are working well enough to handle the treatment.
  • The participant must have recovered from any side effects of previous treatments to a mild level, except for hair loss, which can be more severe.
  • Participants must follow local guidelines for contraception to prevent pregnancy during the study and for a period after the study. Men must agree not to donate sperm and use condoms, while women must not be pregnant or breastfeeding and use effective birth control methods.

Who Cannot Join the Study?

  • Patients with a known EGFR, ALK, ROS-1, or BRAF V600E mutation cannot participate. These are specific changes in genes that can affect cancer growth and treatment.
  • Patients who have received any prior treatment for their metastatic disease are not eligible. Metastatic disease means the cancer has spread to other parts of the body.
  • Patients with other genomic aberrations for which a targeted therapy is available are excluded. Genomic aberrations are changes in the DNA that can be targeted with specific treatments.

Where you can join this trial?

Verified and Recommended Sites

Site Name City Country Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie Lublin Poland

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Caen Normandie Caen France
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Kliniken der Stadt Koeln gGmbH Cologne Germany
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Hospital Del Mar Barcelona Spain
Universita Degli Studi Di Brescia Brescia Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Hospital Universitario Virgen De La Victoria Malaga Spain
Krankenhaus Nordwest GmbH Frankfurt Germany
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie Olsztyn Poland
Med Polonia Sp. z o.o. Poznan Poland
Centre Hospitalier Et Universitaire De Limoges Limoges France
Centre Hospitalier Le Mans Le Mans France
Hospital Universitario Virgen De Valme Sevilla Spain
Hospital Universitario Lucus Augusti Lugo Spain
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Bydgoszcz Poland
Hospital Universitario De Jaen Jaen Spain
Institut de Cancérologie de l’Ouest Saint-Herblain France

Other Sites

Site Name City Country Status
Lungenfachklinik Immenhausen Germany
Spitalul De Psihiatrie Titan Dr. Constantin Gorgos Bucharest Romania
Phiaxvoohozzp Owdybrjdw Oldenburg In Holstein Germany
Adnoo Hwyzlgnojiab Nkap Ahwayx Cvlhnkpa Valenciennes France
Rfqxqnpmrisc Cierzj Cpal Syxjln Floresti Romania
Cbghlko Tocmmlb Wqiptzpfbgjy Jnrz Jexmgstwenei Ssrezk Lodz Poland

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

Trial status

Country Status Recruitment Start
France France
Not recruiting
28.12.2020
Germany Germany
Not recruiting
28.12.2020
Italy Italy
Not recruiting
28.12.2020
Poland Poland
Not recruiting
28.12.2020
Romania Romania
Not recruiting
28.12.2020
Spain Spain
Not recruiting
28.12.2020

Trial locations

Investigated Drugs:

Dostarlimab is a medication used in this trial as a PD-1 inhibitor. It works by helping the immune system recognize and attack cancer cells. In this study, it is combined with chemotherapy to treat patients with metastatic non-squamous non-small cell lung cancer.

Pembrolizumab is another PD-1 inhibitor used in this trial. Like dostarlimab, it helps the immune system target and destroy cancer cells. It is also combined with chemotherapy in this study to treat patients with metastatic non-squamous non-small cell lung cancer.

Chemotherapy refers to the use of drugs to kill or slow the growth of cancer cells. In this trial, chemotherapy is used in combination with either dostarlimab or pembrolizumab to enhance the treatment’s effectiveness against metastatic non-squamous non-small cell lung cancer.

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 starts in the tissues of the lungs and can spread to other parts of the body. Non-small cell lung cancer often grows and spreads more slowly than small cell lung cancer. Symptoms may include a persistent cough, chest pain, and shortness of breath. The progression of the disease can vary, with some cases remaining localized while others may metastasize to distant organs.

Trial ID:
2023-505894-33-00
Protocol code:
213403
NCT ID:
NCT04581824
Trial Phase:
Therapeutic exploratory (Phase II)

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