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

Registered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The trial focuses on patients with locally advanced or metastatic Non-Small Cell Lung Cancer. Treatment combines standard chemotherapy drugs such as cisplatin, carboplatin, paclitaxel and pemetrexed with immune‑targeting medicines called immune checkpoint inhibitors, including atezolizumab, pembrolizumab and nivolumab. Immune checkpoint inhibitors work by blocking a protein called PD‑1 that can keep immune cells from attacking cancer, thereby helping the body’s own defenses to recognize and destroy tumor cells. The chemotherapy drugs are given through a vein (intravenous infusion) to kill cancer cells directly, while the immunotherapy drugs are also given by infusion to boost the immune response.

The purpose of the study is to determine whether continuing the immunotherapy after an initial response provides a longer period without cancer growth compared with stopping the drug. After receiving the combined regimen for about six to twelve months, participants are randomly assigned (randomization) to either keep receiving the immunotherapy or to stop it, and then are monitored with regular imaging scans and blood tests for up to a year. The main outcome measured is the proportion of patients whose disease has not progressed after twelve months (progression‑free rate), and additional observations include how long any response lasts, overall survival, and safety of the treatment.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

13 criteria

  • 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 trial?

5 criteria

  • 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.
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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.

What is already known about the treatment

Nivolumab – This medication is administered intravenously and is used in the treatment of patients with locally advanced or metastatic non-small cell lung carcinoma. It is currently well-documented in medical literature as an immune checkpoint inhibitor, specifically targeting the PD-1 pathway. Nivolumab works by blocking the PD-1 protein on the surface of immune cells, which enhances the body's immune response against cancer cells. It is classified as a monoclonal antibody and is primarily indicated for use in various cancers, including lung cancer, to improve progression-free survival rates.

Investigated diseases

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 detailsLast updated 9 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509490-23-00Protocol codeIB 2019-07Estimated enrolment80 patientsSponsorInstitut Bergonie

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