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
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.	Lodz	Poland
Lungenfachklinik	Immenhausen	Germany
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
Krankenhaus Nordwest GmbH	Frankfurt	Germany
Pius-Hospital Oldenburg	Oldenburg In Holstein	Germany
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie	Olsztyn	Poland
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy	Bydgoszcz	Poland
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Hospital Del Mar	Barcelona	Spain
Hospital Universitario De Jaen	Jaen	Spain
Radiotherapy Center Cluj S.R.L.	Floresti	Romania
Centrul De Oncologie SF Nectarie S.R.L.	Craiova	Romania
Med Polonia Sp. z o.o.	Poznan	Poland
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Centre Hospitalier Le Mans	Le Mans	France
Kliniken der Stadt Koeln gGmbH	Cologne	Germany
Hospital Universitario Virgen De Valme	Sevilla	Spain
Hospital Universitario Lucus Augusti	Lugo	Spain
Spitalul De Psihiatrie Titan Dr. Constantin Gorgos	Bucharest	Romania
Universita Degli Studi Di Brescia	Brescia	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Crxsrm Hlopnlqwpqg Et Unjvigcoqxlsz Dk Ladpszs	Limoges	France
Ahcjq Hfagfoviapdw Notg Axkcxa Cqinfbuy	Valenciennes	France

Trial status

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

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?