Study on the Effectiveness of Retifanlimab 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 metastatic non-small cell lung cancer, which is a type of lung cancer that has spread to other parts of the body. The study is investigating the effectiveness of a treatment that combines a new medication called Retifanlimab (INCMGA00012) with standard chemotherapy drugs. The chemotherapy drugs being used in this study include Carboplatin, Cisplatin, Pemetrexed, and Paclitaxel. Some participants will receive a placebo instead of Retifanlimab to compare the outcomes.

The purpose of the study is to see if adding Retifanlimab to the chemotherapy regimen can improve the overall survival of patients compared to chemotherapy alone. Participants in the study will be randomly assigned to receive either the combination of Retifanlimab and chemotherapy or a placebo and chemotherapy. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are not biased.

Throughout the study, participants will receive their assigned treatments through intravenous infusions, which means the medication is given directly into a vein. The study will monitor participants over a period of time to assess their response to the treatment and any side effects they may experience. The goal is to determine if the new treatment combination can help patients live longer and improve their quality of life.

1 joining the study

Upon joining the study, the patient will be randomly assigned to one of two groups. One group will receive a combination of platinum-based chemotherapy and INCMGA00012, while the other group will receive a combination of platinum-based chemotherapy and a placebo.

2 treatment administration

The treatment involves the administration of medications through intravenous infusion. The specific medications used in the chemotherapy regimen may include carboplatin, cisplatin, pemetrexed, paclitaxel, and retifanlimab.

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, the patient’s health and response to treatment will be closely monitored. This includes regular assessments to evaluate the effectiveness of the treatment and to identify any side effects.

The primary goal is to compare the overall survival of patients receiving the combination of INCMGA00012 and chemotherapy versus those receiving the placebo and chemotherapy.

4 completion of treatment

The treatment phase will continue as per the study protocol until the patient completes the required number of cycles or until the healthcare team decides to stop the treatment based on the patient’s health status.

The estimated end date for the trial is June 30, 2025.

5 follow-up

After completing the treatment phase, the patient will enter a follow-up period. During this time, the patient’s health will continue to be monitored to assess long-term outcomes and any delayed side effects.

The follow-up period is crucial for gathering comprehensive data on the treatment’s impact on the patient’s health and quality of life.

Who Can Join the Study?

Ability to understand and willingness to sign a written informed consent form (ICF) for the study.
Has adequate organ function as shown by specific laboratory tests done within 10 days before starting the study treatment.
Has been evaluated by the study doctor regarding vaccination against COVID-19 before joining the study. Vaccination is strongly recommended but not required.
Is at least 18 years old on the day of signing the informed consent form.
Has a confirmed diagnosis of non-small cell lung cancer (NSCLC) that is at Stage IV. This means the cancer has spread to other parts of the body. For nonsquamous cancer, tests must show the absence of certain gene changes. If these tests are not available, new tests must be done.
Has not received prior treatment for advanced or metastatic NSCLC, except for certain therapies completed at least 12 months before the cancer spread. Participants without access to the best standard treatment options may be included.
Able to provide a sample of tumor tissue for testing during screening or after being diagnosed with metastatic disease. This sample helps confirm the status of a protein called PD-L1.
Has measurable disease according to specific criteria, meaning the cancer can be measured and tracked over time.
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which indicates the participant is fully active or has some symptoms but can carry out light work.
Has a life expectancy of at least 3 months before signing the informed consent form.
Willingness to avoid pregnancy or fathering children during the study and for a specified period after the last dose of treatment. Men must take precautions to avoid fathering children, and women must not be pregnant or breastfeeding and must take precautions to avoid pregnancy.

Who Cannot Join the Study?

Patients with other types of cancer that are not the specific type being studied cannot participate.
Patients who have had a different cancer treatment recently may not be eligible.
Patients with certain health conditions that could interfere with the study may be excluded.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients who are unable to follow the study procedures or attend required visits may not be eligible.
Patients who have allergies to the study medications or similar drugs may be excluded.
Patients who are participating in another clinical trial at the same time may not be eligible.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
University Multiprofile Hospital For Active Treatment Sofiamed OOD	Sofia	Bulgaria
Nemocnice AGEL Ostrava-Vitkovice a.s.	Ostrava	Czechia
Specialized Eye Diseases Hospital For Active Treatment-Varna EOOD	Varna	Bulgaria
Medical Center Nadezhda Clinical EOOD	Sofia	Bulgaria
Fqghozwz nhhsskzug Mnmyn a Hanhudv	Prague	Czechia

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	05.05.2020
Czechia	Not recruiting	05.05.2020

Trial locations

Investigated drugs:

INCMGA00012 is an investigational medication being studied for its potential to treat lung cancer. It is being tested in combination with chemotherapy to see if it can improve outcomes for patients with metastatic squamous and nonsquamous non-small cell lung cancer. This medication is part of a class of drugs that may help the immune system fight cancer cells more effectively.

Platinum-Based Chemotherapy is a standard treatment for various types of cancer, including lung cancer. It works by using platinum compounds to damage the DNA of cancer cells, which can stop them from growing and dividing. In this trial, it is used as a comparison to see if adding INCMGA00012 can provide better results for patients.

Metastatic nonsquamous or squamous non-small cell lung cancer – This is a type of lung cancer that begins in the cells lining the lungs and has spread to other parts of the body. It is categorized into two main types based on the appearance of the cancer cells under a microscope: nonsquamous and squamous. The disease progresses as cancer cells grow uncontrollably, forming tumors that can invade nearby tissues and organs. As it advances, it can spread to distant parts of the body, such as the bones, brain, or liver. Symptoms may include persistent cough, chest pain, and difficulty breathing. The progression of the disease can vary, with some individuals experiencing rapid growth and others having a slower course.

Trial ID:

2022-501987-16-00

Protocol code:

INCMGA 0012-304

NCT ID:

NCT04205812

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness of Retifanlimab 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?