Recruiting

Anti‑PD1 Therapy with pembrolizumab and cemiplimab in first‑line advanced non‑small cell lung cancer patients with high PD‑L1 expression

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What is this trial about?

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

The trial focuses on people with advanced cancer, especially those whose disease has spread and cannot be removed by surgery. One part of the study looks specifically at patients with advanced metastatic non‑small cell lung cancer that shows a high level of a protein called PD‑L1 on tumor cells. Patients must not have certain genetic changes called EGFR, ALK, or ROS1. The treatment being tested is a type of immunotherapy that works by blocking a protein called PD‑1, using medicines known as pembrolizumab and cemiplimab, which are given through an IV infusion.

The main purpose is to see how many participants can go at least 12 weeks without their disease getting worse. After an initial screening, participants receive the infusion every few weeks and are checked regularly with scans and blood tests. Changes in tumor size are measured using standard criteria (RECIST) to determine if the cancer is shrinking, staying the same, or growing. Safety is monitored by asking about side effects and using questionnaires that assess quality of life throughout the study.

The research process

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

Step 1
Initial study visit
You attend the first visit after joining the trial. during this visit you sign the required documents and confirm that you understand the study.
The study team records your personal information and reviews the study schedule with you.
Step 2
Baseline assessments
You provide blood samples that will be used to measure the plasma PTI score and to confirm the presence of PD-L1 on tumor cells. a score greater than 50% is required for this study.
You undergo imaging tests (such as CT or MRI scans) to document the current size and location of the cancer.
You complete questionnaires that assess your health-related quality of life and any symptoms you are experiencing.
Step 3
First infusion of study medication
You receive an intravenous (IV) infusion of the study drug. the medication may be either KEYTRUDA (200 mg of pembrolizumab) or LIBTAYO (350 mg of cemiplimab), depending on the assignment in the trial.
The infusion is administered through a vein over a period of time determined by the study protocol.
Step 4
Subsequent infusion visits
You return for additional infusions of the same medication on the schedule defined by the protocol (the exact interval is not disclosed here). each infusion uses the same dose as the first infusion.
The study staff monitors you during each visit for any immediate reactions.
Step 5
Weekly safety questionnaire
You complete the patient‑reported outcome version of the Common Terminology Criteria for Adverse Events (PRO‑CTCAE) each week. this questionnaire records any new or worsening side effects you may experience.
Step 6
Quality‑of‑life assessments
You fill out the EORTC QLQ‑C30 questionnaire at the start of the trial and then once every three months while you remain in the study. this form evaluates how the treatment affects your daily life and well‑being.
Step 7
Disease evaluation at 12 weeks
Approximately twelve weeks after the first infusion, you undergo repeat imaging scans to determine whether the cancer has progressed.
The result is used to assess the primary outcome of the trial, which is the proportion of patients who have no disease progression at this time point.
Step 8
Ongoing monitoring
Throughout the treatment period you continue to have regular visits for infusions, safety questionnaires, and lab tests.
The study team records any adverse events (side effects) and monitors your overall health.
If the cancer progresses, you develop unacceptable side effects, or the trial reaches its planned end date, treatment may be stopped.
Step 9
End‑of‑treatment visit
When treatment ends, you attend a final visit that includes a physical exam, imaging studies, and completion of the quality‑of‑life questionnaire.
The collected information contributes to the final analysis of the trial outcomes.

Who can join the trial?

21 criteria

Must be at least 12 years old and weigh ≥ 40 kg (the study also requires patients in the NSCLC sub‑group to be ≥ 18 years old).
Must be enrolled in the French social security system.
Must be able to understand the study and give informed consent (or have a legal guardian sign for minors). If the patient cannot sign, an independent witness can confirm the consent.
Must be willing and able to follow the study schedule, including taking the study medication and attending all required visits and tests.
Must have advanced cancer, meaning the cancer cannot be removed by surgery and has spread locally or to other parts of the body (including blood cancers such as leukemias and lymphomas).
For the NSCLC sub‑study, must be receiving first‑line therapy (the first set of treatments given for the disease) for advanced metastatic non‑small cell lung cancer.
Must have a PD‑L1 Tumor Proportion Score (TPS) greater than 50 % (a lab test that measures how much of a protein called PD‑L1 is present on cancer cells).
Must not have genetic changes called EGFR, ALK, or ROS1 mutations (specific alterations that can affect treatment choices).
Must have a PTI score of zero in a blood test taken before the study starts (a score used to predict early disease progression).
Must have at least one measurable tumor lesion according to the RECIST v1.1 criteria (standard rules for measuring tumor size) or an equivalent method for blood cancers.
Must have an ECOG performance status of 0, 1, or 2 (a simple scale that rates how well a person can carry out daily activities, where 0 = fully active and 2 = able to care for self but unable to work).
Must be able to provide a blood sample and, if needed, a tumor biopsy (a small tissue sample). If there are enough cancer cells in bone marrow or blood, a bone‑marrow sample or blood draw can replace the tumor biopsy.
Must have adequate organ function, defined as:
- Total bilirubin ≤ 1.5 × the upper limit of normal (ULN) (or ≤ 3.0 × ULN for certain liver conditions).
- ALT (a liver enzyme) ≤ 3 × ULN (or ≤ 5 × ULN if liver metastases are present).
- Absolute neutrophil count ≥ 1,000 cells/mm³ (a type of white blood cell).
- Platelet count ≥ 100,000 cells/mm³.
- Hemoglobin ≥ 9.0 g/dL (a measure of red blood cells).
- Albumin ≥ 30 g/L (a protein made by the liver).
- Calculated creatinine clearance ≥ 50 mL/min/1.73 m² (a test of kidney function).
- Women who could become pregnant must have a negative pregnancy test (blood or urine) within 7 days before starting treatment.
- Both sexually active women who could become pregnant and men (and their partners) must agree to use two effective forms of birth control, one of which must be a physical barrier (such as a condom), or agree to avoid sexual activity for the required time after the last dose.

Who cannot join the trial?

24 criteria

Severe allergy to any study drug or to contrast dye used in imaging scans.
Significant coughing up blood (hemoptysis) within the past 3 months.
Use of other investigational drugs or participation in another clinical trial within the past 4 weeks.
Major injury or surgery within the past 4 weeks that has not fully healed, or planned major surgery during the study period.
History of serious bleeding or blood‑clot problems (hemorrhagic or thromboembolic events) in the past 3 months.
Significant heart conditions, including fast irregular heartbeat, uncontrolled high blood pressure, unstable chest pain, heart attack in the past year, moderate to severe heart failure, serious rhythm problems, or fluid around the heart.
Ongoing uncontrolled hormone (endocrine) disorders, unless they are stable and treated with medication.
Other cancers diagnosed in the past 5 years, except certain skin cancers, carcinoma in situ, or cured prostate, breast, or bladder cancers without recurrence.
Active serious infections that need systemic antibiotics; a 3‑week gap after antibiotics is required before joining. Well‑controlled HIV or cured hepatitis B/C are allowed.
Gastrointestinal problems that would interfere with absorption of an oral study drug.
Pregnancy or breastfeeding.
History of life‑threatening autoimmune or immune‑mediated inflammatory diseases such as severe colitis, lung inflammation (pneumonitis), Guillain‑Barré syndrome, anti‑phospholipid syndrome, or heart inflammation (myocarditis). Stable autoimmune endocrine diseases and mild skin autoimmune conditions are permitted.
Use of Ganoderma Lucidum (Reishi) mushroom, herbal remedies, or traditional medicines within a few weeks before starting the study or during the study.
Any psychological, social, lifestyle, or medical factor that, in the investigator’s opinion, could prevent proper study participation, including active alcoholism or drug abuse.
Being deprived of liberty, under protective custody, or under guardianship.
For the META‑1 part: having received prior anti‑PD‑1/PD‑L1, anti‑CTLA‑4, anti‑LAG‑3, or anti‑TIM‑3 immunotherapy.
For the META‑1 part: allergy (hypersensitivity) to pembrolizumab or cemiplimab or any of their ingredients.
Use of long‑term systemic immunosuppressive medicines unless stopped at least 4 weeks before enrollment.
Recent cancer treatments (chemotherapy, hormone therapy, radiotherapy, immunotherapy, monoclonal antibodies, or tyrosine‑kinase inhibitors) within the past 4 weeks or five drug half‑lives, whichever is shorter.
Receipt of a live, attenuated vaccine within 4 weeks before registration.
Radiotherapy to the specific tumor lesions being measured for response, unless disease progression after radiotherapy has been documented.
Ongoing significant side‑effects from previous cancer treatments that could interfere with safety or effectiveness assessments.
Symptomatic brain metastases or cancer spread to the spinal lining (leptomeningeal disease), unless a specific protocol allows it; asymptomatic cases are permitted but steroids cannot be used.
Tumors located next to large cavities or major blood vessels that carry a high risk of massive bleeding or organ perforation.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer
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Toulon, France
Hopital Ambroise Pare
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Boulogne-Billancourt, France
Institut Gustave Roussy
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Villejuif, France

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Investigated drugs

Pembrolizumab
is an immunotherapy drug that blocks a protein called PD‑1 on immune cells. By blocking this protein, the drug helps the body’s own immune system notice and attack cancer cells. In this trial, pembrolizumab is given through an IV infusion as a single‑agent treatment for patients with advanced lung cancer who have high levels of PD‑L1 on their tumors.
Cemiplimab
is also an immunotherapy that works in the same way as pembrolizumab by blocking the PD‑1 protein. This allows the immune system to better recognize and fight cancer. In the study, cemiplimab is administered intravenously as a single‑agent therapy for the same group of advanced lung cancer patients with high PD‑L1 expression.

What is already known about the treatment

Pembrolizumab
This medication is supplied as a sterile solution for infusion and is given by slow intravenous injection into a vein. It is an approved and widely used drug that has been studied in many clinical trials and appears in current medical guidelines. Pembrolizumab is mainly prescribed for advanced cancers such as non‑small cell lung cancer, melanoma, and bladder cancer, especially when tumors show high PD‑L1 expression. It works by binding to the PD‑1 protein on immune cells, blocking its interaction with cancer‑cell signals, which helps the immune system recognize and attack the tumor; it belongs to the class of immune checkpoint inhibitor monoclonal antibodies.
Cemiplimab
This drug comes as a concentrate for solution for infusion and is administered by intravenous infusion into a vein. It is an approved therapy that has been investigated in numerous studies and is listed in recent oncology treatment references. Cemiplimab is used to treat advanced cutaneous squamous cell carcinoma, basal cell carcinoma, and non‑small cell lung cancer when certain biomarkers are present. It acts by attaching to the PD‑1 receptor on immune cells, preventing the tumor from turning off the immune response, and is classified as an immune checkpoint inhibitor monoclonal antibody.

Investigated diseases

Metastatic cancer
It is cancer that has spread from its original site to other parts of the body. The disease starts as a primary tumor that grows locally, then cancer cells break away and travel through blood or lymph to form new tumors elsewhere. As more sites become involved, the overall burden increases and symptoms may appear from the affected organs. The spread can happen quickly or slowly depending on the type of cancer. Over time, the disease can involve multiple organ systems.
Advanced non‑small cell lung carcinoma
It is a type of lung cancer that originates in the lining of the airways and does not have small‑cell features. In advanced stages, the tumor has grown beyond the lung and may involve nearby structures or distant sites. The cancer cells continue to multiply, leading to larger tumors and possible spread to lymph nodes, bones, brain, or other organs. The disease often shows high levels of a protein called PD‑L1 on the tumor cells, which can influence its behavior. As the disease progresses, symptoms related to lung function and other organ involvement may develop.