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Pharmacokinetic study of pembrolizumab and drug combination in patients with non‑small cell lung cancer or head and neck squamous cell carcinoma

Registered drugNo placebo
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What is this trial about?

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

People with Non-small cell lung cancer or Head and neck squamous cell carcinoma often receive a combination of medicines that are given through a vein. One of the key medicines used to help the immune system fight the cancer is pembrolizumab, an immunotherapy drug that blocks a protein called PD-1. In addition, standard chemotherapy drugs such as paclitaxel, bevacizumab, gemcitabine and cetuximab may be used after the immunotherapy to try to shrink the tumor further.

The study’s purpose is to find out whether the amount of pembrolizumab still present in the body after the last dose can predict how well the later chemotherapy works. Participants first receive pembrolizumab as part of their regular care, then a blood sample is taken about three weeks after the final dose. After this, they start chemotherapy and doctors watch the tumor size for three months, looking for shrinkage or stability, and continue to follow patients for up to a year to see how long the cancer stays under control and how long patients live without the disease returning.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial screening and baseline assessments

    After joining the study, you will undergo basic health checks, blood tests, and imaging to confirm eligibility and record the current status of your cancer.

  2. Step 2

    Administration of pembrolizumab

    You will receive a single intravenous infusion of pembrolizumab at a dose of 400 mg. the medication is given through a vein over a short period in a clinical setting.

  3. Step 3

    Waiting period and blood sample collection

    For the next 21 days after the pembrolizumab infusion, no additional study drug is given. on day 21, a blood sample will be taken to measure the remaining amount of pembrolizumab in your body.

  4. Step 4

    Start of salvage chemotherapy

    After the blood sample, you will begin salvage chemotherapy, which is given as part of routine cancer care. the chemotherapy may include one or more of the following intravenous drugs:

    - paclitaxel: 90 mg per kilogram of body weight

    - bevacizumab: 15 mg per kilogram of body weight

    - gemcitabine: 1250 mg per square meter of body surface area

    - cetuximab: 400 mg per square meter of body surface area

    Each drug is delivered through an intravenous infusion. the exact schedule and number of cycles are decided by your treating physician and follow standard clinical practice.

  5. Step 5

    Assessment of tumor response at 3 months

    Approximately three months after starting salvage chemotherapy, imaging tests will be performed to evaluate the objective response rate. the results are classified as:

    - complete response (the tumor is no longer detectable)

    - partial response (the tumor has shrunk but is still present)

    - stable disease (the tumor has not grown or shrunk significantly).

  6. Step 6

    Long‑term follow‑up at 12 months

    Twelve months after the start of chemotherapy, further evaluations will be made to determine:

    - progression‑free survival: the time from the first chemotherapy dose until the cancer shows signs of growth

    - cancer‑specific survival: the time from the first chemotherapy dose until death caused by the cancer.

Who can join the trial?

11 criteria

  • Be at least 18 years old.
  • Have health coverage through a social security health insurance plan.
  • Have been diagnosed with either non‑small cell lung cancer (including adenocarcinoma or squamous cell carcinoma) or head and neck squamous cell carcinoma that is p16‑negative for oropharyngeal tumors (meaning the tumor does not show a specific protein called p16).
  • Have cancer that is recurrent or has spread (metastatic) and cannot be treated with curative local therapy.
  • Have experienced disease progression while receiving pembrolizumab immunotherapy (standard dose of 200 mg every 3 weeks) given as the first treatment for metastatic disease, either alone or together with chemotherapy as described for each cancer type.
  • Be eligible to receive salvage chemotherapy (additional chemotherapy given after the immunotherapy stops), such as weekly Paclitaxel (with or without Bevacizumab) for lung adenocarcinoma, Gemcitabine for lung squamous cell carcinoma, or weekly Paclitaxel and/or Cetuximab for head and neck cancer.
  • Have disease that can be measured according to RECIST 1.1 criteria (a set of rules doctors use to determine if a tumor is getting bigger, smaller, or staying the same).
  • Have a performance status score of 0, 1, or 2 (a simple scale that describes how well you can carry out daily activities, where 0 means fully active and 2 means up and about more than 50% of waking hours).
  • Show baseline laboratory results that meet the usual safety requirements for starting salvage chemotherapy (for example, adequate blood counts, liver and kidney function).
  • If a tissue sample is needed, agree to undergo a biopsy and have blood test results showing an INR less than 1.5 (a measure of blood clotting ability) and a platelet count greater than 50,000 per microliter (platelets help blood clot).
  • Voluntarily agree to take part in the study, sign the informed consent form, and allow the extra blood sampling required by the trial.

Who cannot join the trial?

5 criteria

  • Having had another type of cancer in the past, unless that cancer has been in complete remission (fully gone) for more than three years, a cutaneous basal cell carcinoma (a common skin cancer) that was completely removed, or a very early‑stage cancer called carcinoma in situ (cancer that has not spread) that was treated.
  • Currently taking part in another clinical trial that has rules preventing you from joining this study.
  • Being a minor (under the legal age to give consent for medical research).
  • Needing a tissue biopsy and taking certain blood thinners that cannot be stopped before the procedure, such as clopidogrel, prasugrel, ticlopidine, low‑molecular‑weight heparin, fondaparinux, abciximab, eptifibatide, tirofiban, argatroban, bivalirudin, or dabigatran, when these medicines cannot be paused for the required time.
  • Being part of a vulnerable group, including pregnant women, women in labour, breastfeeding mothers, people who are detained or imprisoned, people who cannot give consent, or individuals living in a health or social care institution for reasons unrelated to research.
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Investigated drugs

  • Paclitaxel

    is a chemotherapy drug that is given through an IV. It works by stopping cancer cells from dividing and growing. In this study, it is part of the standard treatment that patients receive before the new drug is tested.

  • Bevacizumab

    is an IV medication that blocks a protein that helps tumors grow new blood vessels. By cutting off the blood supply, it can slow the tumor’s growth. It is also used as part of the usual chemotherapy regimen in the trial.

  • Gemcitabine

    is an IV chemotherapy that interferes with the DNA of cancer cells, making it harder for them to multiply. It is included in the background chemotherapy that all participants receive.

  • Cetuximab

    is given by IV and works by blocking a signal (the EGFR pathway) that many cancer cells use to grow and survive. It is another component of the standard chemotherapy given to patients in the study.

  • Pembrolizumab

    is an immunotherapy drug given through an IV. It blocks a protein called PD‑1, which helps the immune system recognize and attack cancer cells. In this trial, pembrolizumab is the new treatment being studied. Researchers are measuring how much of the drug remains in the body after the last dose and how that leftover amount may affect the success of the chemotherapy that follows.

What is already known about the treatment

  • Paclitaxel

    This drug is given by intravenous infusion and is an approved chemotherapy used for many cancers, including non‑small cell lung cancer. It works by holding together tiny structures inside cells that are needed for cell division, which stops cancer cells from multiplying. Paclitaxel belongs to the taxane class of chemotherapy agents and is widely studied in medical literature. It is a standard part of many cancer treatment regimens.

  • Bevacizumab

    Bevacizumab is administered as an intravenous infusion and is an approved anti‑cancer medicine for several tumors such as non‑small cell lung cancer and head‑and‑neck cancer. It blocks a protein called VEGF that tells blood vessels to grow, so tumors receive less blood and cannot grow as fast. This drug is classified as a monoclonal antibody that inhibits blood‑vessel formation. It has a long record of use and many published studies.

  • Gemcitabine

    Gemcitabine is given by intravenous infusion and is an approved chemotherapy for cancers including non‑small cell lung cancer and pancreatic cancer. It mimics a natural building block of DNA, causing the cancer cell’s DNA to break apart and the cell to die. The medication is classified as a nucleoside analog antimetabolite. It is well‑known in clinical practice and extensively described in the literature.

  • Cetuximab

    Cetuximab is administered through an intravenous infusion and is an approved treatment for head‑and‑neck squamous cell carcinoma and some other tumors. It attaches to a receptor on the cell surface called EGFR, preventing signals that tell the cell to grow and divide. This drug belongs to the class of monoclonal antibodies that target growth‑factor receptors. It has a solid safety and efficacy record in medical studies.

  • Pembrolizumab

    Pembrolizumab is delivered by intravenous infusion and is an approved immune‑checkpoint inhibitor used for many cancers, including non‑small cell lung cancer and head‑and‑neck cancer. It blocks a protein called PD‑1 on immune cells, allowing the body’s own immune system to recognize and attack tumor cells. The medication is classified as a PD‑1 blocking monoclonal antibody. It is widely studied and routinely used in modern cancer therapy.

Investigated diseases

  • Non‑small cell lung cancer (NSCLC)

    a type of lung cancer that originates in the cells lining the airways and makes up most lung cancer cases. It usually grows slowly at first, forming a mass that can block airflow. Over time the tumor can spread to nearby lymph nodes and then to distant organs such as the brain, bones, or liver. The disease often progresses from a localized stage to an advanced stage where multiple sites are involved.

  • Head and neck squamous cell carcinoma (HNSCC)

    a cancer that arises from the flat cells covering the mouth, throat, voice box, and related structures. It typically starts as a small lesion that can enlarge and invade surrounding tissues. As it grows, it may spread to nearby lymph nodes and later to distant parts of the body. The condition advances from a localized tumor to one that affects multiple regions within the head and neck and beyond.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-526866-26-00Protocol code2023/60Estimated enrolment110 patientsSponsorCentre Antoine Lacassagne

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