Study on the Effects of Pembrolizumab, Atezolizumab, and Nivolumab in Patients with Advanced Non-Small Cell Lung Cancer

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What is this study about?

This clinical trial is focused on studying the effects of different treatments for (NSCLC), a type of lung cancer that is locally advanced or has spread to other parts of the body. The study involves several medications, including (also known as Keytruda), , , (also known as Tecentriq), , (also known as Alimta), and (also known as Opdivo). These medications are used in various combinations as part of and treatments. The purpose of the study is to assess the long-term benefits of these treatments in patients who have shown a response to , which are drugs that help the immune system fight cancer.

Participants in the study will receive one of the treatments through an , which means the medication is given directly into a vein. The study will last for up to 24 months, during which time the effects of the treatment will be monitored. Some patients will continue their treatment, while others may stop, to see how each approach affects the progression of the disease. The study aims to understand how long patients can remain free from cancer progression and to identify any side effects associated with the treatments.

Throughout the study, various tests and scans will be conducted to monitor the cancer’s response to the treatment. This includes looking at the , which is the area surrounding the tumor, to better understand how the cancer and the immune system interact. The study will also explore potential , which are biological indicators that can help predict how well a patient might respond to treatment. The ultimate goal is to optimize the duration of immunotherapy for patients with NSCLC, ensuring they receive the most effective treatment for their condition.

1 joining the study

Upon joining the study, participation is confirmed through a signed informed consent form. This document ensures understanding of the study’s purpose and procedures.

2 initial assessment

An initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

A pregnancy test is required for women of childbearing potential.

3 treatment initiation

Treatment begins with the administration of immune checkpoint inhibitors (ICI) such as pembrolizumab, atezolizumab, or nivolumab. These are given through an intravenous infusion.

The treatment may also include chemotherapy agents like paclitaxel, cisplatin, carboplatin, or pemetrexed, depending on the specific treatment plan.

4 treatment duration

The treatment is administered over a period of 6 to 12 months. The exact duration depends on the response to the treatment.

5 response evaluation

The response to treatment is evaluated using imaging techniques such as CT scans or PET-CTs. These assessments help determine the effectiveness of the treatment.

6 randomization

After the initial treatment period, participants are randomly assigned to either continue or discontinue the treatment. This step is crucial for assessing the long-term benefits of the therapy.

7 follow-up assessments

Regular follow-up assessments are conducted to monitor the progression of the disease and any side effects. These assessments include imaging and laboratory tests.

8 study completion

The study is expected to conclude by February 2026. Final assessments will be conducted to evaluate the overall outcomes of the treatment strategies.

Who Can Join the Study?

Patients must have a type of lung cancer called non-small cell lung carcinoma, which can be either squamous or non-squamous.
Women who can have children must have a negative pregnancy test within 7 days before joining the study.
Patients must have social security that complies with French law.
Patients must be willing and able to attend scheduled visits, follow the treatment plan, and undergo tests and other study procedures.
Patients must sign a written consent form voluntarily before any study-specific procedures begin.
The disease must be locally advanced (spread within the lung area) or metastatic (spread to other parts of the body).
For non-squamous lung cancer, the tumor must not have certain genetic changes known as oncogenic addiction, such as no activating EGFR mutation, and no ALK or ROS1 rearrangement.
Patients must have been treated with a type of therapy called immune checkpoint inhibitor (ICI) either as the first or second treatment option. For those in the first line, ICI can be used alone or with chemotherapy. The ICI treatment must have started 6 to 12 months before joining the study.
Patients must have at least one measurable tumor according to specific criteria (RECIST v1.1) before starting ICI treatment, confirmed by a centralized review. The tumor must be at least 10 mm in one dimension.
Patients must have shown a response to ICI treatment (either complete or partial) between 6 and 12 months after starting the treatment, confirmed by a centralized review of all CT scans or PET-CTs done since the start of ICI treatment.
There must be at least one tumor that can be biopsied for research purposes. If the tumor has completely responded or is too small, suitable archived tumor material must be available.
Patients must be 18 years of age or older.
Patients must have a performance status of less than 2, which means they should be able to carry out daily activities with some limitations.

Who Cannot Join the Study?

Patients who do not have locally advanced or metastatic Non-Small Cell Lung Carcinoma cannot participate. Locally advanced means the cancer has spread to nearby areas, and metastatic means it has spread to other parts of the body.
Patients who have not experienced a response to immune checkpoint inhibitor therapy between 6 and 12 months after starting treatment are excluded. Immune checkpoint inhibitors are drugs that help the immune system fight cancer.
Patients who are not within the specified age range for the study cannot participate. The study includes certain age groups, but the exact ages are not specified here.
Both male and female patients are eligible, so exclusion is not based on gender.
Patients who are considered part of a vulnerable population are not excluded. Vulnerable populations typically include groups like children or those unable to give consent, but this study does not exclude them based on vulnerability.

Where you can join this trial?

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Trial status

Country	Status	Recruitment Start
France	Not recruiting	03.08.2021

Trial locations

Investigated drugs:

PD-1 Inhibitor is a type of medication used in this trial to help the immune system fight non-small cell lung cancer. It works by blocking a specific protein on the surface of immune cells, which can help the immune system recognize and attack cancer cells more effectively. This medication is being studied to see if it provides long-term benefits for patients who have already responded to treatment within the first 6 to 12 months.

Investigated diseases:

Non-small cell lung cancer

Non-Small Cell Lung Carcinoma – This is a type of lung cancer that includes several subtypes such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is characterized by the uncontrolled growth of cells in the tissues of the lung, which can form tumors. The disease often progresses slowly compared to other types of lung cancer, but it can spread to other parts of the body if not managed. Symptoms may include a persistent cough, chest pain, and difficulty breathing. As the disease advances, it may lead to more severe respiratory issues and other systemic symptoms.

Trial ID:

2023-509490-23-00

Protocol code:

IB 2019-07

NCT ID:

NCT04880382

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of Pembrolizumab, Atezolizumab, and Nivolumab in Patients with Advanced Non-Small Cell Lung Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?