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Pembrolizumab alone versus pembrolizumab with chemotherapy drug combination in women with advanced non‑small cell lung cancer

Verified siteRegistered drugNo placebo
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What is this trial about?

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

Advanced Non‑small cell lung cancer is a type of lung cancer that has spread beyond the lungs and cannot be cured with surgery alone. The trial includes women whose tumors have a high level of a protein called PD‑L1, which can help the immune system recognize cancer cells. The study uses the medicine pembrolizumab, given through a vein, either by itself or together with standard chemotherapy drugs such as pemetrexed, paclitaxel albumin‑bound, cisplatin and carboplatin. Pembrolizumab works by helping the body’s own immune cells attack the cancer.

The purpose of the study is to compare how well pembrolizumab alone works versus pembrolizumab combined with chemotherapy in women with advanced non‑small cell lung cancer that expresses high levels of PD‑L1. Participants receive an infusion of the assigned treatment every three weeks, and doctors perform regular scans and blood tests to see if the cancer is growing, using criteria called RECIST. The main goal is to measure progression‑free survival, which is the time a person lives without the cancer getting worse. Other outcomes include overall survival, the length of time a person lives after starting treatment; objective response rate, the proportion of people whose tumors shrink; toxicity, which refers to side effects; and quality of life, assessed with a questionnaire known as EQ‑5D‑5L.

The study lasts for several years, with treatment given for up to about two years and follow‑up visits continuing after treatment stops to monitor health and any late effects. Throughout the trial, participants attend clinic visits for the infusions, imaging scans, and to complete quality‑of‑life questionnaires, allowing researchers to compare the two treatment approaches.

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

    Initial Study Visit and First Infusion

    You arrive at the clinic for the first study visit after being enrolled. A brief physical examination, blood tests, and baseline imaging are performed to document your health status before treatment begins.

    The study medication is given by intravenous (IV) infusion. If you are assigned to the pembrolizumab‑only group, you receive pembrolizumab 200 mg IV. If you are assigned to the combination group, you receive the same dose of pembrolizumab plus the chemotherapy agents pemetrexed 895 mg IV, paclitaxel albumin‑bound 179 mg IV, and either cisplatin 134 mg IV or carboplatin 625 mg IV, according to the study protocol.

    The infusion is administered over a period of about 30 minutes, and you are monitored for any immediate reactions.

  2. Step 2

    Baseline Assessments

    During the same visit, detailed questionnaires about your quality of life are completed, including the EQ‑5D‑5L form.

    Additional laboratory tests are taken to establish baseline values for kidney function, blood counts, and other safety parameters.

  3. Step 3

    Regular Treatment Cycles

    You return to the clinic at the interval defined by the study (typically every three weeks) for each treatment cycle.

    Before each infusion, blood samples are drawn and a brief physical check is performed to ensure it is safe to receive the medication.

    The same IV doses described in step 1 are administered again. In the combination arm, the chemotherapy agents are given together with pembrolizumab for the planned number of cycles, after which pembrolizumab may continue alone.

  4. Step 4

    Imaging Assessments

    Every few treatment cycles (for example, every six weeks), you undergo imaging studies such as CT scans. These images are evaluated using the RECIST v1.1 criteria to measure any changes in tumor size.

    The results help determine whether the disease is stable, shrinking, or progressing.

  5. Step 5

    Safety Monitoring

    At each visit, you are asked about any new symptoms or side effects. Blood tests are repeated to monitor organ function and blood counts.

    Any adverse events are recorded and managed according to the study’s safety guidelines.

  6. Step 6

    Quality‑of‑Life Questionnaires

    At scheduled intervals, you complete the EQ‑5D‑5L questionnaire again. This provides information on how treatment may be affecting your daily activities and overall well‑being.

  7. Step 7

    Continuation or Discontinuation of Treatment

    Treatment continues until one of the following occurs: disease progression is observed on imaging, side effects become unacceptable, or the study reaches its planned end date.

    If treatment is stopped, a final set of assessments—including imaging, laboratory tests, and quality‑of‑life questionnaires—is performed.

  8. Step 8

    Post‑Treatment Follow‑Up

    After stopping the study medication, you attend regular follow‑up visits to monitor long‑term outcomes. These visits may include physical examinations, blood tests, and imaging to assess overall survival and any later disease progression.

    The frequency of follow‑up visits is defined by the study protocol and may become less frequent over time.

  9. Step 9

    Study Completion

    When the final follow‑up visit is completed, the study concludes for you. All collected data are used to compare the effectiveness of pembrolizumab alone versus pembrolizumab with chemotherapy in women with advanced non‑small cell lung cancer.

Who can join the trial?

13 criteria

  • Ability to understand what the study is about and what it means for you.
  • Must be a woman who is at least 18 years old.
  • Must give written informed consent before any study procedures.
  • If you can become pregnant, you must use a very effective birth‑control method (less than 1% chance of failure each year) during the study and for 6 months after the last dose; women who are post‑menopausal or have had surgery that makes them unable to have children do not need birth control.
  • Must have advanced (stage IV) non‑small cell lung cancer that was confirmed by a tissue test, either squamous cell carcinoma or adenocarcinoma.
  • Must have testing that shows the cancer does NOT have EGFR, ALK, or ROS1 genetic changes (these are specific mutations that can affect treatment).
  • Must have a PD‑L1 tumor proportion score of 50% or higher, measured by a certified lab test. (PD‑L1 is a protein that can help the immune system recognize cancer.)
  • Must have an ECOG performance status of 0, 1, or 2 (a scale that measures how well you can carry out daily activities; 0 = fully active, 2 = up and about more than 50% of waking hours).
  • Must have at least one tumor that can be measured on scans according to RECIST v1.1 criteria (a standard way doctors measure tumor size).
  • Must have recent lab results (within 14 days) showing adequate blood, kidney, liver, and clotting function:
    • Blood (bone marrow) counts: hemoglobin ≥ 8.0 g/dL, neutrophils ≥ 2.0 × 10⁹/L, total white blood cells > 4.0 × 10⁹/L, platelets ≥ 100 × 10⁹/L, and albumin ≥ 3.0 g/dL.
    • Kidney function: creatinine clearance ≥ 60 mL/min and serum creatinine ≤ 1.5 times the normal upper limit.
    • Liver function: bilirubin ≤ 1.5 times normal (up to 3 times if you have Gilbert’s syndrome), AST and ALT ≤ 2.5 times normal (up to 5 times if liver metastases are present), alkaline phosphatase ≤ 2.5 times normal (up to 5 times if bone or liver metastases are present).
    • Blood clotting: INR and aPTT ≤ 1.5 times normal unless you are on anticoagulant medication with therapeutic levels.

Who cannot join the trial?

19 criteria

  • If your tumor contains both small‑cell and non‑small cell lung cancer types, you cannot join the study. If it has mixed non‑small cell types, you may join only when the main type (at least half) is either squamous cell carcinoma or adenocarcinoma.
  • If you have another cancer besides lung cancer that is untreated or needs active treatment within the past three years, you are not eligible.
  • If you have serious heart problems such as NYHA class III or higher heart failure (significant shortness of breath with everyday activities), dangerous heart rhythm problems, a heart attack in the last six months, or a heart‑pumping measurement called left ventricular ejection fraction below 50%, you cannot participate.
  • If you have an active autoimmune disease or chronic inflammatory condition that required strong medicines (like steroids or other immune‑suppressing drugs) in the past two years—examples include celiac disease, lupus, sarcoidosis, Wegener’s granulomatosis, Graves’ disease, rheumatoid arthritis, hypophysitis, or uveitis—you are excluded. Certain conditions such as vitiligo, alopecia, stable hypothyroidism, well‑controlled type I diabetes, chronic skin problems that do not need systemic therapy, or any disease that has been inactive for five years may be allowed with special approval. Recurrent or chronic diverticulitis is also excluded.
  • If you have taken immune‑suppressing medicines (other than low‑dose steroids, topical, inhaled, or local injections) within 14 days before the first study drug, you cannot join.
  • If you received drugs that boost the immune system, such as interferon or interleukin‑2 (IL‑2), within four weeks (or five drug half‑lives, whichever is longer) before starting the study, you are not eligible.
  • If you received a live vaccine (for example, measles, mumps, rubella, or yellow fever) within 30 days before the first dose, you cannot participate.
  • If you are known to be allergic to any part of the chemotherapy drugs or to pembrolizumab, you are excluded.
  • If you have any other medical condition that the doctor believes makes the study too risky for you, you will not be allowed to join.
  • If you are currently pregnant or breastfeeding, you cannot take part in the trial.
  • If you are incarcerated or placed in a facility by a court order, you are not eligible.
  • If you are already taking part in another clinical trial that uses an investigational drug, you cannot join this study (participating in non‑interventional studies or registries is allowed).
  • If you have already received systemic treatment for advanced lung cancer or any previous therapy that targets the PD‑1/PD‑L1 pathway (including drugs like anti‑CTLA‑4, anti‑TIGIT, or other checkpoint inhibitors), you are excluded.
  • If you are receiving radiation therapy for cancer at the same time, you cannot join, except for limited palliative radiation to areas not being studied.
  • If you could have all of your limited (oligometastatic) cancer spots removed by surgery and you refuse the surgery or other local treatments, you are not eligible.
  • If you have active or worsening brain metastases that cause symptoms, or if you need increasing doses of steroids for brain symptoms within two weeks before enrollment (more than 10 mg of prednisolone daily), you cannot participate.
  • If you have leptomeningeal disease (cancer spread to the membranes covering the brain and spinal cord), you are excluded.
  • If you have a history of interstitial lung disease (a group of lung disorders causing scarring), you cannot join.
  • If you have an active infection that requires intravenous antibiotics or other strong medicines within two weeks before the first study dose, you are not eligible (mild infections treated with oral medication may be allowed).
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Investigated drugs

  • Pembrolizumab

    is a type of immunotherapy that helps the body’s own immune system see and attack cancer cells. It works by blocking a protein called PD‑L1, which many tumors use to hide from immune cells. In this study, patients receive it through an IV. One group gets pembrolizumab alone, while another group receives it together with chemotherapy.

  • Pemetrexed

    is a chemotherapy medicine that stops cancer cells from making the building blocks they need for DNA. By interfering with DNA production, it slows or stops the growth of the tumor. It is given by IV and is part of the chemotherapy combination used with pembrolizumab in the trial.

  • Paclitaxel albumin‑bound

    (often called nab‑paclitaxel) is a chemotherapy drug that blocks the ability of cancer cells to divide. It is attached to a protein called albumin, which helps the medicine get into the tumor more easily. This drug is also given through an IV and is included in the combination therapy arm of the study.

  • Cisplatin

    is a platinum‑based chemotherapy that damages the DNA inside cancer cells, making it hard for them to grow and survive. It is administered by IV and is one of the chemotherapy agents used together with pembrolizumab in the combination treatment.

  • Carboplatin

    is another platinum‑based chemotherapy similar to cisplatin, but it is often easier on the kidneys. It also damages cancer cell DNA and helps stop tumor growth. Like the other chemotherapy drugs, it is given intravenously and is part of the combination regimen with pembrolizumab.

What is already known about the treatment

  • Pembrolizumab

    This drug is given by intravenous infusion, usually every three weeks. It is an approved cancer immunotherapy that is widely used and described in many medical studies. The main use is for treating advanced non‑small cell lung cancer that shows high PD‑L1 levels, and it works by blocking the PD‑1 protein on immune cells so the body can better attack cancer. It belongs to the class of immune checkpoint inhibitors, specifically PD‑1 inhibitors.

  • Pemetrexed

    Pemetrexed is administered through an intravenous infusion, often once every three weeks. It is an established chemotherapy drug with a solid record in medical literature. It is mainly used for non‑small cell lung cancer and works by stopping the cancer cells from making DNA and RNA, which they need to grow. This medication is classified as an antifolate antimetabolite.

  • Paclitaxel albumin‑bound

    This formulation of paclitaxel is given by intravenous infusion, typically on a weekly or three‑weekly schedule. It is a well‑known chemotherapy agent that has been studied extensively. It is used to treat non‑small cell lung cancer and works by locking the cell’s internal scaffolding (microtubules) in place, preventing the cancer cells from dividing. It belongs to the taxane class of chemotherapy drugs.

  • Cisplatin

    Cisplatin is delivered by intravenous infusion, usually every three weeks. It is a long‑standing chemotherapy drug with a large amount of research supporting its use. It is used for many cancers, including advanced non‑small cell lung cancer, and it works by forming strong links in the DNA that stop the cells from copying their genetic material. This medication is classified as a platinum‑based chemotherapy.

  • Carboplatin

    Carboplatin is given by intravenous infusion, often on a three‑weekly cycle. It is an approved chemotherapy drug with extensive clinical experience. It is used for non‑small cell lung cancer and works by attaching to DNA and creating damage that leads to cell death. It is also part of the platinum‑based chemotherapy class.

Investigated diseases

Advanced non‑small cell lung cancer - It is a type of lung cancer that arises from the cells lining the airways. In the advanced stage, the tumor has grown larger and may extend into nearby structures or spread to other parts of the body such as lymph nodes, bones, or brain. The disease typically progresses slowly at first, but over time the cancer cells multiply and can cause increasing blockage of airways and reduced lung function. As it advances, new tumors may appear in other organs, leading to further symptoms. The growth pattern varies between individuals, with some experiencing rapid expansion while others have a more gradual course.
Trial detailsLast updated 11 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-525387-18-00Protocol codeIFEMEstimated enrolment406 patientsSponsorDeutsches Krebsforschungszentrum Stiftung Des Oeffentlichen Rechts

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