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Study on the Effectiveness of Retifanlimab with Chemotherapy for Patients with Metastatic Non-Small Cell Lung Cancer

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What is this trial about?

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

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.

The research process

The trial runs in 5 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, 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. Step 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. Step 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. Step 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. Step 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 trial?

11 criteria

  • 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 trial?

7 criteria

  • 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.
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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.

What is already known about the treatment

INCMGA00012 – This medication is administered intravenously, meaning it is given directly into a vein. It is currently being studied in clinical trials for its effectiveness in treating metastatic nonsquamous or squamous non-small cell lung cancer. The main therapeutic indication is to improve overall survival when combined with platinum-based chemotherapy. At the molecular level, INCMGA00012 works by targeting specific proteins on cancer cells, helping the immune system recognize and attack these cells. It is classified as an immunotherapy agent, which is a type of treatment that uses the body's immune system to fight cancer.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501987-16-00Protocol codeINCMGA 0012-304Estimated enrolment576 patientsSponsorIncyte Corp.

sourced from the EU Clinical Trials Register and site verification

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