This clinical trial is focused on studying a type of lung cancer known as metastatic squamous non-small cell lung cancer (NSCLC) that shows a specific protein called PD-L1. The study is comparing two treatments: one involves a medication called rilvegostomig (also known by its code name AZD2936), and the other uses a medication called pembrolizumab. Both treatments are combined with chemotherapy, which is a common cancer treatment that uses drugs to kill cancer cells.
The purpose of the study is to see how effective and safe these treatments are for patients with this type of lung cancer. Participants will receive either rilvegostomig or pembrolizumab, along with chemotherapy drugs such as carboplatin and paclitaxel. The study will monitor how long patients live and how long they remain free from cancer progression, which means the cancer does not get worse. The study will also look at other factors like the overall response to the treatment and any side effects experienced.
Participants will receive their treatment through an intravenous infusion, which means the medication is given directly into a vein. The study will take place over several months, and participants will have regular check-ups to monitor their health and the effects of the treatment. The goal is to find out which combination of treatments works best for this type of lung cancer.
1randomization to treatment arm
after joining, you are assigned to receive either rilvegostomig plus chemotherapy or pembrolizumab plus chemotherapy. the assignment is decided by the study system and is not influenced by you.
2initial treatment day
on the first day of treatment, you receive an intravenous infusion (medicine delivered through a vein) of the chemotherapy drugs:
carboplatin 6 mg, paclitaxel 200 mg per square meter of body surface area, or the albumin‑bound form paclitaxel albumin‑bound 100 mg per square meter, depending on the protocol.
at the same time, you receive the study drug assigned to you:
if you are in the rilvegostomig arm, a dose of 0 mg is given as an intravenous infusion;
if you are in the pembrolizumab arm, a dose of 200 mg is given as an intravenous infusion.
3oral background medication
you take mycophenolate mofetil by mouth at a dose of 3 g each day. this medication is taken continuously while you remain in the study.
4additional background infusion
you receive an intravenous infusion of infliximab at a dose of 5 mg per kilogram of body weight. the timing of this infusion follows the study schedule.
5repeated treatment cycles
the chemotherapy and the assigned study drug are repeated in cycles according to the study schedule, typically every few weeks.
each cycle includes the same doses of carboplatin, paclitaxel (or paclitaxel albumin‑bound) and the study drug (rilvegostomig or pembrolizumab).
oral mycophenolate mofetil continues daily, and any scheduled infliximab infusions are given as defined by the protocol.
6monitoring and assessments
before each treatment cycle, you undergo safety checks that may include blood tests, vital‑sign measurements, and performance‑status evaluation.
these assessments help determine whether the next cycle can be given safely.
7end of treatment
treatment stops when the study protocol defines the end, when disease progression is observed, or when side effects become unacceptable.
after the last treatment, you continue to be followed for overall survival and disease‑free time until the study end date of 2029‑10‑08.
Who Can Join the Study?
Have a type of lung cancer called squamous non‑small cell lung cancer (NSCLC) that was confirmed by looking at tissue or cells under a microscope.
The cancer must be at Stage IV (meaning it has spread to other parts of the body) and cannot be cured with surgery or radiation.
No known genetic changes (mutations) that would allow the use of other specially‑targeted medicines.
Provide a tumor sample that shows the protein PD‑L1 is present on at least 1 % of cancer cells (PD‑L1 helps the immune system recognize the tumor).
Have at least one tumor spot that has not been treated with radiation, can be seen on a scan, and is large enough to measure (at least 10 mm in its longest side, or a lymph node at least 15 mm in its short side) using a CT or MRI scan.
Have healthy enough organ and bone marrow function (the organs and the part of the blood‑forming system that makes blood cells must work well enough to handle treatment).
Be an adult (usually 18 years or older) and can be either male or female.
The study can include participants who are considered vulnerable, as long as they meet all the other requirements.
Who Cannot Join the Study?
You cannot join if your cancer includes small cell or neuroendocrine types, which are different from the type being studied.
You cannot join if you have cancer that has spread to the brain (brain metastases) unless the spots cause no symptoms, are stable, and you have not needed medicines like steroids (anti‑inflammation drugs) or anticonvulsants (seizure medicines) for at least 7 days before the study starts. Also, at least 2 weeks must have passed since any brain radiation or surgery, and you must have fully recovered from any side‑effects of that treatment.
You cannot join if you have already received any systemic therapy (treatment that travels through the whole body) for advanced or metastatic non‑small cell lung cancer.
You cannot join if you have previously been treated with medicines that block PD‑1 or PD‑L1, which are types of immune‑checkpoint inhibitors.
You cannot join if you have ever received a drug that blocks TIGIT or any other experimental therapy that targets the immune system’s regulatory pathways.
You cannot join if you have had another main cancer (primary malignancy) unless that cancer was treated with a cure‑intent, has been disease‑free for at least 2 years, and is considered low risk for coming back.
You cannot join if you have an active or past autoimmune or inflammatory disease that needs ongoing treatment with steroids or other medicines that suppress the immune system.
You cannot join if you have a weakened immune system (primary immunodeficiency) or any current serious infection.
You cannot join if you have an active infection with tuberculosis (TB).
Paclitaxel is a chemotherapy drug given through an IV. In this study it is used as part of the standard platinum‑based chemotherapy regimen to help kill cancer cells in the lungs.
Paclitaxel albumin‑bound (Abraxane) is a version of paclitaxel that is attached to a protein (albumin) to help the medication get into the tumor more easily. It is also given by IV and is combined with other chemotherapy drugs to treat the lung cancer.
Mycophenolate mofetil is an oral medication that suppresses the immune system. In the trial it is used as a background therapy to help control any immune‑related side effects that may arise from the cancer treatments.
Rilvegostomig is an experimental IV infusion being tested as a new cancer treatment. It is given together with the standard platinum‑based chemotherapy to see if it improves survival compared with the current standard therapy.
Pembrolizumab (Keytruda) is an immunotherapy drug that helps the body’s immune system recognize and attack cancer cells. In this study it is given by IV as the comparator treatment, combined with the same chemotherapy, to see how it works against the new experimental drug.
Carboplatin is a chemotherapy drug administered through an IV. It is a core part of the platinum‑based chemotherapy regimen used for all patients in the trial, working together with other drugs to stop cancer growth.
Infliximab is an IV medication that reduces inflammation by blocking a specific protein in the immune system. It is included as background therapy to manage potential inflammatory side effects during the trial.
Metastatic squamous non‑small cell lung cancer expressing PD‑L1 – It is a type of lung cancer that starts in the flat cells lining the airways and has spread beyond the original lung. The cancer cells show a protein called PD‑L1 on their surface. As the disease progresses, new tumors can appear in other parts of the body such as the bones, brain, or liver. The growth of the tumors may cause increasing coughing, shortness of breath, or chest discomfort. Over time, the cancer can affect overall lung function and may lead to more widespread disease.
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