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Tislelizumab with drug combination in patients with PD-L1‑high metastatic non‑small cell lung cancer and high tumor burden

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What is this trial about?

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

The study focuses on Non-Small Cell Lung Cancer that has spread to other parts of the body (stage IV) and shows a high level of the protein called PD‑L1, described as PD-L1high. Participants receive an immune‑system‑boosting drug named tislelizumab given through an IV line. In one group the drug is given alone, while in the other group it is combined with a type of cancer‑killing medicine that contains the metal platinum, referred to as platinum-based chemotherapy. The chemotherapy may include medicines such as pemetrexed, cisplatin, carboplatin, paclitaxel or the albumin‑bound form paclitaxel albumin-bound, and another immune drug called pembrolizumab. The purpose of the study is to determine whether adding the platinum‑based chemotherapy to the immune drug can keep the cancer from growing for a longer time compared with the immune drug alone.

Individuals who agree to join are randomly assigned to receive either the single drug or the combination treatment. All medicines are given by IV infusion, usually once every three weeks, for several treatment cycles. After the treatment period, participants continue to be seen regularly for health checks, scans, and questionnaires about quality of life, allowing researchers to track how the disease behaves over time and to monitor any side effects.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline Assessments

    After joining the study you will undergo a series of baseline assessments that include a physical examination, blood tests, and imaging scans to document the current state of your disease.

    You will also complete a questionnaire that measures your quality of life before any study medication is given.

  2. Step 2

    Randomization

    Based on the study design you will be randomly assigned to one of two treatment groups.

    One group receives only tislelizumab (a medication given by intravenous infusion at a dose of 400 mg), while the other group receives tislelizumab together with a platinum‑based chemotherapy regimen.

  3. Step 3

    Treatment – Tislelizumab Monotherapy (Arm A)

    If you are assigned to the monotherapy arm you will receive tislelizumab 400 mg by intravenous infusion on the scheduled treatment day.

    The infusion is performed in a clinical setting and the frequency and total number of doses are defined by the study protocol.

  4. Step 4

    Treatment – Tislelizumab Plus Platinum‑Based Chemotherapy (Arm B)

    If you are assigned to the combination arm you will receive tislelizumab 400 mg by intravenous infusion together with several chemotherapy medicines.

    The chemotherapy includes:

    Cisplatin 75 mg/m² by intravenous infusion,

    Carboplatin 400 mg/m² by intravenous infusion,

    Paclitaxel 200 mg/m² by intravenous infusion,

    Paclitaxel albumin‑bound 100 mg/m² by intravenous infusion, and

    Pemetrexed 500 mg/m² by intravenous infusion.

    All medicines are given on the same treatment day according to the schedule set by the study, and the number of cycles is determined by the protocol and your physician.

  5. Step 5

    Safety Monitoring Visits

    During the treatment period you will attend regular clinic visits where your vital signs, blood counts, and organ function are checked.

    These visits allow the study team to detect any side effects early and to adjust treatment if necessary.

  6. Step 6

    Imaging Assessments

    To evaluate how the disease is responding, you will undergo imaging scans (such as CT or MRI) at intervals specified in the study protocol.

    The scans are compared with the baseline images to determine whether the tumor has shrunk, remained stable, or grown.

  7. Step 7

    Quality‑of‑Life Questionnaires

    You will be asked to complete a quality‑of‑life questionnaire (FACT‑L) at three time points: before treatment starts, periodically while you are receiving medication, and at the end of treatment.

    These questionnaires help researchers understand how the therapy affects your daily well‑being.

  8. Step 8

    End of Treatment Evaluation

    When treatment is stopped—because the protocol allows, disease progression occurs, or side effects become unacceptable—you will have a final set of assessments.

    This includes a physical exam, blood tests, imaging, and the final quality‑of‑life questionnaire.

  9. Step 9

    Post‑Treatment Follow‑Up

    After treatment ends you will continue to be monitored for survival and disease status according to the follow‑up schedule in the protocol.

    Follow‑up visits may include physical examinations, blood work, and periodic imaging to track long‑term outcomes.

Who can join the trial?

10 criteria

  • Written informed consent must be signed and the participant must be able to follow the study requirements.
  • Women who could become pregnant must use highly effective birth control, have a negative pregnancy test within the last 7 days, and cannot be breastfeeding. Women who cannot become pregnant must meet one of the following: be post‑menopausal for at least 12 months, have had a hysterectomy or removal of both ovaries (or both tubes) at least 6 weeks ago, or have a condition that makes pregnancy impossible.
  • Must have a diagnosis of non‑small cell lung cancer confirmed by tissue testing that has never been treated before (treatment‑naïve) and is classified as stage IV according to the UICC 9th edition.
  • Must have a PD‑L1 ≥ 50% result (PD‑L1 is a protein used to decide if certain immune therapies may work).
  • Must have a high tumor burden, meaning the largest tumor or at least one metastasis is 50 mm (about 2 inches) or larger, and the cancer cannot be treated with a curative surgery or radiation approach.
  • The disease must be measurable on scans according to RECIST v1.1 (a standard system doctors use to track tumor size).
  • No actionable genomic alterations that would allow a different targeted drug to be used first.
  • Must be eligible for platinum‑based chemoimmunotherapy (a combination of platinum chemotherapy drugs and immune‑system‑stimulating medicines).
  • Must be 18 years of age or older.
  • Patients with brain metastases are allowed unless they are awaiting whole brain radiation therapy (WBRT); if they have already completed WBRT, they can join the study at least 7 days after finishing the radiation.

Who cannot join the trial?

8 criteria

  • Any health condition that the doctor believes could make the study unsafe for you, make it hard for you to follow the study steps, or affect the quality of the results – this includes a pre‑existing autoimmune disease (where the immune system mistakenly attacks the body) that would prevent you from receiving the study medication.
  • Being enrolled in another clinical study at the same time, unless it is only an observational (non‑treatment) study or you are in the follow‑up period after a previous interventional study.
  • Having another active cancer (malignancy) besides non‑small cell lung cancer that requires treatment.
  • Having a known hypersensitivity (allergy) to the study drugs, any part of the medication, their breakdown products, or other ingredients in the formulation.
  • Using systemic (whole‑body) corticosteroids higher than 10 mg per day of prednisone (or an equivalent medicine) within 3 days before the first dose of the study drug, except when steroids are given only as pre‑medication to prevent allergic reactions during a scan.
  • Being pregnant or breast‑feeding, or being able to become pregnant without using a highly effective method of birth control (failure rate less than 1 % per year).
  • Having been incarcerated (in jail) or being placed in a care facility by a court order.
  • Being unable to give informed consent because you do not understand the nature, importance, and implications of the clinical trial.
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Investigated drugs

  • Tislelizumab

    is an immunotherapy drug that helps the body’s immune system recognize and attack cancer cells. In this study it is given through an IV and is the main immune‑based treatment being tested, either alone or together with chemotherapy.

  • Pemetrexed

    is a chemotherapy medicine that stops cancer cells from making the building blocks they need to grow. It is given by IV and is combined with other chemotherapy drugs to give a stronger attack on the lung cancer.

  • Paclitaxel albumin‑bound

    (often called nab‑paclitaxel) is a form of chemotherapy that uses tiny particles to deliver the drug directly to cancer cells. It is given by IV and is used together with other chemotherapy agents to help shrink the tumors.

  • Cisplatin

    is a traditional chemotherapy drug that damages the DNA of cancer cells, making it hard for them to multiply. In this trial it is part of the platinum‑based chemotherapy regimen that is added to the immunotherapy.

  • Carboplatin

    works in a similar way to cisplatin by interfering with cancer‑cell DNA. It is another option for the platinum‑based chemotherapy component that is combined with the immune drug.

  • Pembrolizumab

    is another immunotherapy that helps the immune system find and destroy cancer cells. It is included in the list of test medicines and may be used for comparison with the primary study drug.

What is already known about the treatment

  • Tislelizumab

    This drug is given by intravenous infusion as a solution for infusion. It is an approved immune checkpoint inhibitor that is used mainly for treating non‑small cell lung cancer and other cancers. It works by binding to the PD‑1 protein on immune cells, stopping it from turning off the immune response against tumor cells. It belongs to the class of monoclonal antibodies that block PD‑1.

  • Pemetrexed

    Pemetrexed is administered by intravenous infusion as a sterile solution. It is an approved chemotherapy drug for non‑small cell lung cancer and malignant pleural mesothelioma. The medicine blocks several enzymes needed for making DNA and RNA, which slows the growth of cancer cells. It is classified as an antimetabolite (folate‑type) chemotherapy agent.

  • Paclitaxel albumin‑bound

    This formulation is given by intravenous infusion as a concentrated solution that contains the drug bound to albumin particles. It is approved for use in non‑small cell lung cancer and several other solid tumors. The drug binds to tiny structures called microtubules inside cells and holds them together, which prevents cancer cells from dividing. It is a taxane‑type chemotherapy agent.

  • Cisplatin

    Cisplatin is delivered by intravenous infusion as a sterile solution. It is an established chemotherapy drug for many cancers, including non‑small cell lung cancer. The medication forms strong links between DNA strands, which stops the DNA from being read and leads to cancer cell death. It belongs to the class of platinum‑based chemotherapy agents.

  • Carboplatin

    Carboplatin is given by intravenous infusion as a clear solution. It is widely used in the treatment of non‑small cell lung cancer and other solid tumors. Like other platinum drugs, it creates connections in the DNA that interfere with the cancer cell’s ability to grow and survive. It is classified as a platinum‑based chemotherapy agent.

  • Pembrolizumab

    Pembrolizumab is administered by intravenous infusion as a concentrated solution for infusion. It is an approved immune checkpoint inhibitor for non‑small cell lung cancer and many other cancers. The drug attaches to the PD‑1 protein on immune cells, blocking the signal that tells the immune system to ignore the tumor, thereby enhancing the body’s attack on cancer. It is a monoclonal antibody that blocks PD‑1.

Investigated diseases

Stage IV non‑small cell lung cancer - It is a cancer that starts in the lining of the airways of the lung and does not have the small cells seen in another type of lung cancer. In stage IV, the tumor has grown beyond the lung and can spread to other parts of the body such as the bones, brain, or liver. The disease often begins with a cough or shortness of breath and may later cause chest pain or weight loss as it expands. As cancer cells multiply, they can block airways and reduce the lung’s ability to exchange oxygen. The spread to distant organs marks a more extensive disease course.
Trial detailsLast updated 14 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-525497-18-00Protocol codeAIO-TRK/YMO-0425Estimated enrolment230 patientsSponsorAIO-Studien gGmbH

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