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Study of Cemiplimab, Platinum and Gemcitabine in Treatment‑Naïve Patients with Advanced Squamous Non‑Small Cell Lung Cancer

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What is this trial about?

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

Advanced squamous non-small cell lung cancer is a form of lung cancer that has spread beyond the lungs and is difficult to treat. The study evaluates a combination of a medicine called cemiplimab given by intravenous infusion, together with standard chemotherapy drugs including a platinum‑based agent and gemcitabine. Participants are selected based on the activity level of an enzyme in the blood called cytidine deaminase, which helps determine how the body may respond to the treatment.

The purpose of the study is to explore how well this drug combination works in patients who have not received previous therapy for this disease and who show low baseline enzyme activity. After enrollment, participants receive regular infusions of the study medicines over several weeks, followed by periodic clinic visits where doctors check health status, perform blood tests, and take imaging scans to monitor the cancer.

Throughout the trial, patients are observed for how long they live, how long the cancer stays under control, and any side effects that may occur. The study follows each participant from the first treatment until the end of the monitoring period, recording any changes in tumor size or overall health as part of the safety and effectiveness assessment.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Registration and baseline assessment

    After joining the study you will sign the consent form and provide personal health information.

    The study team will perform baseline imaging and blood tests, including a test for cytidine deaminase activity (cda) to determine eligibility.

  2. Step 2

    First treatment cycle

    On day 1 you will receive an intravenous infusion (iv) of cemiplimab at a dose of 350 mg.

    At the same time you will receive the chemotherapy drugs platinum and gemcitabine as prescribed by the investigator.

  3. Step 3

    Subsequent treatment cycles

    The combination of cemiplimab, platinum, and gemcitabine will be repeated in each cycle according to the study schedule.

    Each cycle typically lasts several weeks; the exact interval is defined in the protocol.

  4. Step 4

    Monitoring during treatment

    Before every infusion you will have blood tests to check organ function and look for side effects.

    The study doctor will ask about any new symptoms and may adjust treatment if needed.

  5. Step 5

    Tumor response assessments

    Periodic scans (such as ct or pet) will be performed to see how the tumor is responding.

    The results are compared with the baseline images to determine response categories such as complete response, partial response, stable disease, or progression.

  6. Step 6

    End of treatment

    Treatment will stop if the disease progresses, side effects become unacceptable, or the planned number of cycles is completed as outlined in the protocol.

  7. Step 7

    Follow‑up after treatment

    After the last infusion you will have scheduled visits to monitor overall survival and any long‑term effects.

    These visits may include additional imaging and blood tests at intervals defined by the study.

Who can join the trial?

25 criteria

  • Informed consent: You must sign a written form agreeing to follow the study rules.
  • You must be at least 18 years old.
  • You must have a diagnosis of advanced squamous non‑small cell lung cancer confirmed by a lab test of tumor tissue.
  • Your cancer must be stage IV (spread) or have returned after previous treatment, as defined by standard staging guidelines.
  • You must not have received any chemotherapy or other systemic cancer drugs for the current metastatic disease.
  • If you had chemotherapy or chemoradiotherapy before the cancer spread, you need a treatment‑free interval of at least 6 months.
  • If you received an anti‑PD‑(L)1 immunotherapy before, you also need a treatment‑free interval of at least 6 months.
  • You must have a known PD‑L1 tumor status (a lab test that looks for a specific protein on the cancer cells).
  • You must not need chest radiation at the same time as the study.
  • Your ECOG performance status must be 0‑1 (meaning you are fully active or able to do light work).
  • You should have a life expectancy of at least 12 weeks.
  • You need at least one tumor that can be measured on a scan (CT or MRI), at least 10 mm in size (or a lymph node at least 15 mm), not in the brain and not previously irradiated.
  • Your blood counts must be adequate:
    • Absolute neutrophil count ≥ 1,500 per microliter
    • Hemoglobin ≥ 9.0 g/dL
    • Platelet count ≥ 100,000 per microliter
    • Your liver and kidney function must be adequate:
      • Total bilirubin ≤ 1.5 × the normal upper limit
      • ALT and AST ≤ 2.5 × normal (or ≤ 5 × if the liver has tumor)
      • Serum creatinine ≤ 1.5 × normal or creatinine clearance ≥ 60 mL/min
      • Your blood clotting must be normal:
        • International Normalized Ratio (INR) ≤ 1.5
        • Partial thromboplastin time (PTT) < 1.5 × normal
        • You must be able to follow the study schedule and procedures as judged by the doctor.
        • Women who could become pregnant must have a negative pregnancy test, not be breastfeeding, and either be post‑menopausal or agree to use a highly effective birth‑control method (such as hormonal pills, an intrauterine device, permanent sterilization, or a vasectomized partner) during treatment and for several months after the last dose. They also must not donate or freeze eggs during this time.
        • Women who cannot become pregnant because of surgery (removal of uterus and ovaries) or permanent sterilization are also eligible.
        • Men who are sexually active must agree to use condoms during treatment and for several months after the last dose, and must not donate sperm during that time.
        • All participants must give written informed consent and any required local approvals before any study procedures.

Who cannot join the trial?

32 criteria

  • EGFR mutation, ALK or ROS1 genetic changes: Having these specific gene alterations (checked especially in never‑smokers) excludes you from the study.
  • Prior allogeneic stem cell or solid organ transplant: If you have received a donor stem cell transplant or any organ transplant, you cannot join.
  • Uncontrolled medical conditions: Any health problem that could get worse with the study drugs or cannot be controlled, such as a serious infection, uncontrolled diabetes, or fluid around the heart (pericardial effusion), makes you ineligible.
  • Symptomatic brain metastases or spinal cord compression: Brain tumors causing symptoms or compression of the spinal cord that need immediate radiation prevent participation.
  • Concurrent cancer treatments: Receiving any other chemotherapy, immunotherapy, targeted therapy, or biological therapy for cancer at the same time (hormone therapy for non‑cancer reasons is allowed) excludes you.
  • Recent investigational drugs: Taking any other experimental drug within 30 days before the study start, or being enrolled in another clinical trial (except observational studies), disqualifies you.
  • Other serious diseases or lab abnormalities: Any additional disease, metabolic problem, physical exam finding, or lab result that suggests a condition that makes the study drug unsafe or raises the risk of serious side effects will exclude you.
  • Autoimmune or inflammatory disorders: Having a current or past autoimmune disease (where the immune system attacks the body) prevents enrollment.
  • Autoimmune neurological syndromes: History of conditions such as non‑infectious encephalitis, Lambert‑Eaton syndrome, or other immune‑mediated paraneoplastic syndromes excludes you.
  • Recent live‑virus vaccination: Receiving a live‑virus vaccine within 30 days before treatment (flu shots without live virus are allowed) makes you ineligible, and you must not receive a live vaccine while on study or for 30 days after the last dose. COVID‑19 vaccine must be given at least one week before the study medication.
  • History of idiopathic pulmonary fibrosis or active lung inflammation: Prior scarring of the lungs (pulmonary fibrosis) or any type of pneumonitis (lung inflammation) seen on a screening CT scan excludes you. Prior radiation‑related lung scarring is allowed.
  • Uncontrolled hepatitis B infection: Positive hepatitis B surface antigen (HBsAg) with active infection that is not well‑controlled makes you ineligible; controlled hepatitis B patients must be on antiviral therapy and monitored.
  • Prior anti‑PD‑1/PD‑L1/PD‑L2 or anti‑CTLA‑4 therapy: Having received any of these immune‑checkpoint drugs for metastatic disease excludes you.
  • Recent immune‑stimulating agents: Use of drugs such as interferon or interleukin‑2 (IL‑2) within 4 weeks (or five drug half‑lives) before starting the study prevents participation.
  • Recent systemic steroids or immunosuppressants: Taking corticosteroids or other immune‑suppressing medicines within 14 days of randomization excludes you.
  • History of leptomeningeal disease: Prior cancer spread to the membranes covering the brain and spinal cord makes you ineligible.
  • Conditions that could confound study results: Any disease, treatment, or laboratory abnormality that might confuse the study outcomes or make participation unsafe, as judged by the investigator, excludes you.
  • Allergies to study drugs: Known severe reactions or hypersensitivity to any of the study medications or their ingredients disqualify you.
  • Unresolved toxicity from prior cancer therapy: Moderate or worse side effects (grade 2 or higher) from previous treatment that are still present, except for hair loss, skin color change, or certain lab values, exclude you; nerve damage (neuropathy) will be reviewed case‑by‑case.
  • Substance abuse or interfering conditions: Ongoing substance abuse, or medical, psychological, or social problems that could interfere with staying in the study or completing assessments, make you ineligible.
  • Pregnancy, breastfeeding, or lack of birth control: Being pregnant or nursing, or not agreeing to use effective contraception from screening until at least 6 months after the last chemotherapy dose (or 4 months after the last cemiplimab dose, whichever is later), excludes you.
  • Blood donation during the study: Donating blood while participating in the trial is not allowed.
  • Positive hepatitis B core antibody with detectable virus: If you have HBcAb positive and HBV DNA is detectable, you must start antiviral therapy before entering; otherwise you are excluded.
  • Uncontrolled fluid collections: Ongoing pleural effusion (around the lungs), pericardial effusion (around the heart), or ascites (in the abdomen) that require repeated drainage exclude you (indwelling catheters are allowed).
  • Uncontrolled high calcium levels: Hypercalcemia (blood calcium above normal limits) that is symptomatic or not controlled makes you ineligible.
  • Significant heart disease: Heart failure worse than NYHA class 2, active coronary artery disease (heart attack or acute syndrome within the past year), serious heart rhythm problems needing medication, or uncontrolled high blood pressure exclude you.
  • Recent stroke or mini‑stroke: Having a transient ischemic attack or full stroke within the past year prevents participation.
  • Active SARS‑CoV‑2 infection: Current COVID‑19 infection makes you ineligible.
  • Other active infections: Any infection requiring hospitalization or IV antibiotics within 2 weeks of the first dose, including tuberculosis, hepatitis B, or hepatitis C (unless the infection is well‑controlled as described), excludes you.
  • Recent major injury or extensive radiation: Significant traumatic injury, or radiation therapy involving a large field within the last 4 weeks, or planned major surgery during the study period excludes you (palliative radiation to a small area is allowed if finished at least 2 weeks before enrollment).
  • Other malignancies: Having another current or past cancer, except for certain skin cancers, early‑stage cervical cancer, surgically cured prostate cancer, or cancers treated more than 5 years ago with no signs of recurrence, makes you ineligible.
  • Recent major surgery: Undergoing major surgery (including open biopsy) within 28 days before the first dose of study treatment excludes you.
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Investigated drugs

  • Cemiplimab

    is an immunotherapy drug that helps the body’s immune system recognize and attack cancer cells. In this study, it is given by IV infusion and is combined with chemotherapy to see if it improves outcomes for patients with advanced squamous non‑small cell lung cancer that has low activity of a specific enzyme (cytidine deaminase). The goal is to determine whether adding cemiplimab to standard chemotherapy can increase the chance of tumor shrinkage and longer survival.

  • Platinum chemotherapy

    refers to a class of chemotherapy drugs that contain platinum, such as cisplatin or carboplatin. These drugs damage the DNA of cancer cells, making it harder for them to grow and divide. In the trial, platinum is used together with other agents as part of the standard chemotherapy backbone, providing the main cytotoxic attack on the lung cancer while the immunotherapy works to stimulate the immune response.

  • Gemcitabine

    is a chemotherapy medication that interferes with the building blocks needed for cancer cells to copy their DNA. It is given by IV infusion and is combined with platinum to form a common chemotherapy regimen for squamous lung cancer. In this study, gemcitabine works alongside platinum and cemiplimab to try to achieve better control of the tumor and improve patient outcomes.

What is already known about the treatment

CEMIPLAMAB - Cemiplimab is given by an intravenous (IV) infusion, usually over about 30 minutes. It is an approved medicine in many countries for treating certain skin cancers and some lung cancers, and it continues to be studied in trials like this one. The drug works by blocking a protein called PD‑1 on immune cells, which helps the body’s own immune system recognize and attack tumor cells. It belongs to the class of immune‑checkpoint inhibitors, which are special types of monoclonal antibodies.

Investigated diseases

Advanced squamous non‑small cell lung cancer - It is a cancer that begins in the flat, squamous cells that line the airways of the lungs and belongs to the group of non‑small cell lung cancers. In its advanced stage, the tumor has grown beyond the original lung site and may involve nearby lymph nodes. Over time the disease can spread to other parts of the body such as the brain, bones, or liver. The growth of the tumor often leads to a gradual increase in size and the appearance of new lesions as it progresses.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517799-40-00Protocol codeGOIRC-04-2024Estimated enrolment108 patientsSponsorGOIRC Gruppo Oncologico Italiano Di Ricerca Clinica

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