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Study comparing QL2107 and pembrolizumab in patients with resected non-small cell lung cancer receiving adjuvant therapy

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What is this trial about?

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

This study focuses on patients with Non-small Cell Lung Cancer (NSCLC) who have had their cancer surgically removed. The study compares two medications: QL2107, which is being tested as a potential biosimilar medication, and Keytruda (also known as pembrolizumab). A biosimilar is a medication that is very similar to an already approved biological medicine. The purpose is to determine if QL2107 works in the same way as Keytruda in the body.

The treatment involves receiving either QL2107 or Keytruda through intravenous infusion (given directly into a vein). The medication is given every three weeks for up to 12 months. Both medications are given at a dose of up to 200 milligrams per infusion. Patients who participate in the study will have had their cancer completely removed through surgery and will have already completed chemotherapy treatment before starting this medication.

Throughout the study, doctors will take blood samples to measure how the medication moves through the body. These measurements will help determine if QL2107 and Keytruda behave similarly in patients' bodies. The study is "double-blind," which means neither the patients nor the doctors know which medication each patient is receiving during the study.

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

    Initial assessment

    The trial begins after completion of platinum-based chemotherapy, which must have been completed between 3 and 12 weeks before starting the study

    A full medical imaging assessment (CT or MRI scans of chest, abdomen, pelvis, and brain) will be performed to confirm there is no evidence of cancer

    Your PD-L1 status will be checked using either existing reports or a tissue sample

  2. Step 2

    Treatment initiation - Cycle 1

    You will receive either QL2107 or Keytruda® (pembrolizumab) through an intravenous infusion

    Blood samples will be collected to measure drug concentration levels

    Each treatment cycle lasts 21 days

  3. Step 3

    Monitoring phase - Cycles 2-6

    You will continue receiving intravenous treatment every 21 days

    Blood samples will be taken before doses at Cycle 2 (Week 4), Cycle 4 (Week 10), Cycle 5 (Week 13), and Cycle 6 (Week 16)

  4. Step 4

    Key measurement period - Cycle 7

    Additional blood samples will be collected during Cycle 7 (Week 19) to measure drug concentration levels

    This is an important phase for measuring how the medication maintains stable levels in your body

  5. Step 5

    Continued treatment - Through Cycle 10

    Treatment continues with regular infusions every 21 days

    A final set of blood samples will be taken during Cycle 10 (Week 28)

    The study will continue monitoring your progress through the treatment period

Who can join the trial?

8 criteria

  • You must voluntarily agree to participate, sign the informed consent form, and be able to follow all study procedures
  • You must be at least 18 years old when signing the consent form
  • You must have had complete surgical removal of Stage II or IIIA non-small cell lung cancer (NSCLC) with clear surgical margins and no cancer remaining in lymph nodes
  • You must be willing to provide tissue samples or existing test results for PD-L1 testing (a protein marker that helps determine treatment response)
  • You must have completed platinum-based chemotherapy that:
    • Started within 12 weeks after surgery
    • Finished between 3 and 12 weeks before study enrollment
    • You must have no evidence of cancer on recent imaging tests (CT scans or MRI of chest, abdomen, pelvis, and brain) done within 12 weeks before joining the study
    • You must have good physical function ability, scoring either 0 (fully active) or 1 (restricted in strenuous activity but able to carry out light work) on the ECOG performance scale

Who cannot join the trial?

12 criteria

  • History of treatment with any anti-PD-1 or anti-PD-L1 therapy (types of immunotherapy medications)
  • Active infection requiring systemic treatment (medications that affect the whole body)
  • Known active hepatitis B or hepatitis C infection
  • Known history of HIV infection
  • Active autoimmune disease requiring systemic treatment (conditions where the immune system attacks healthy cells)
  • History of organ transplant requiring immunosuppressive therapy (medications that lower immune system activity)
  • Unstable brain metastases (cancer that has spread to the brain and is not controlled)
  • Pregnant or breastfeeding women
  • Major surgery within 4 weeks before starting the study
  • Active second cancer (except for adequately treated non-melanoma skin cancer or in situ cervical cancer)
  • Severe heart conditions including heart failure, uncontrolled high blood pressure, or unstable heart rhythm
  • Any condition that, in the opinion of the study doctor, would interfere with the safety of the participant
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Investigated drugs

  • QL2107

    is an experimental medication being tested as a biosimilar to Keytruda. A biosimilar is a highly similar copy of an already approved biological medicine. This medication is being studied for treating lung cancer patients who have had their cancer surgically removed.

  • Keytruda

    (pembrolizumab) is an immunotherapy medication that helps the body's immune system detect and fight cancer cells. It works by blocking a protein called PD-1, which normally prevents the immune system from attacking cancer cells. It is already approved and used as a standard treatment for various types of cancer, including non-small cell lung cancer.

What is already known about the treatment

  • Pembrolizumab (Keytruda)

    A monoclonal antibody medication administered through intravenous infusion that belongs to the class of immune checkpoint inhibitors used in cancer immunotherapy. This medication works by blocking the PD-1 protein on T cells, which enables the immune system to better recognize and attack cancer cells, particularly in the treatment of non-small cell lung cancer. Pembrolizumab has been extensively studied in clinical trials and is approved by major regulatory agencies worldwide, demonstrating significant effectiveness in improving survival rates for patients with various types of cancer, especially when used as adjuvant therapy following surgical removal of tumors.

  • QL2107

    A biosimilar candidate medication to Keytruda (pembrolizumab), administered through intravenous infusion and designed to match the original drug's effectiveness in treating non-small cell lung cancer. As a biosimilar, it is developed to have highly similar properties to the reference product Keytruda, including the same mechanism of action of blocking PD-1 proteins on T cells to enhance the immune system's ability to fight cancer cells. This medication is currently undergoing clinical trials to demonstrate its pharmacokinetic equivalence to the original Keytruda, particularly in the context of adjuvant therapy for patients who have undergone surgical resection of non-small cell lung cancer.

Investigated diseases

Non-small cell lung cancer - A type of lung cancer that begins in the large cells of the lungs, including both squamous cells and adenocarcinomas. It develops when cells in the lungs begin to grow abnormally and form tumors. The disease typically starts in the cells that line the airways of the lungs, gradually spreading to nearby tissues. This form of lung cancer tends to grow and spread more slowly than small cell lung cancer. The condition affects the respiratory function as the tumor grows within the lung tissue.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519883-42-00Protocol codeQL2107-102Estimated enrolment146 patientsSponsorQilu Pharmaceutical Co. Ltd.

sourced from the EU Clinical Trials Register and site verification

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