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Carboplatin‑based drug combination for advanced non‑small cell lung cancer patients with interstitial lung disease

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

The trial focuses on people with advanced Non Small Cell Lung Cancer who also have Interstitial Lung Disease. In the first treatment stage, the chemotherapy drugs carboplatin and paclitaxel are given, sometimes together with the targeted drug bevacizumab. In the second stage, patients may receive another chemotherapy chosen by the doctor or one of the immune‑based medicines pembrolizumab or nivolumab.

The main goal is to see how well the first set of medicines controls the cancer and to assess how the second‑line medicines affect breathing problems caused by the lung disease. Participants receive a series of intravenous infusions over several weeks, followed by regular check‑ups that include blood tests and imaging. Imaging is performed with a CT scan, which is a special X‑ray that creates detailed pictures of the lungs and chest.

After the initial treatment period, patients are monitored for up to six months to record any worsening of breathing that might require stopping the medication, as well as overall health outcomes such as how long the disease stays stable and overall survival. All side effects are recorded and graded according to standard cancer‑treatment safety guidelines. The study follows a set schedule of clinic visits, drug administration, and imaging assessments.

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

    Baseline assessment and randomization

    After signing the consent form, baseline medical tests are performed, including imaging of the chest and lung function measurements.

    The patient is assigned to a treatment group for the first‑line therapy.

  2. Step 2

    First‑line chemotherapy start

    On day 1, an intravenous infusion of carboplatin is given at a dose of 900 mg.

    Starting the same day, an intravenous infusion of paclitaxel is administered once each week at 90 mg per square meter of body‑surface area.

    If the protocol includes it, an intravenous infusion of bevacizumab is added at 10 mg per kilogram of body weight, usually given every three weeks.

    The schedule is repeated for several cycles, typically every three weeks for carboplatin and every week for paclitaxel, until the disease progresses or side effects become unacceptable.

  3. Step 3

    First‑line efficacy evaluation

    After approximately eight weeks, a computed‑tomography (ct) scan of the chest is performed.

    The scan is reviewed to determine whether the disease is stable, partially responding, or fully responding.

  4. Step 4

    Decision to start second‑line therapy

    If the disease has progressed or if the first‑line treatment is stopped because of toxicity, the patient moves to second‑line therapy.

    The investigator selects one of two possible arms for the second‑line period.

  5. Step 5

    Second‑line arm a – investigator‑chosen chemotherapy

    The patient receives an intravenous chemotherapy drug chosen by the investigator. possible agents and their usual doses are:

    pemetrexed 500 mg per square meter, given every three weeks;

    gemcitabine 1150 mg per square meter, given every three weeks;

    vinorelbine 25 mg per square meter, given weekly;

    Each drug is administered by infusion into a vein according to the schedule selected for the patient.

  6. Step 6

    Second‑line arm b – immunotherapy

    The patient receives either:

    pembrolizumab 200 mg given intravenously every three weeks, or

    nivolumab 240 mg given intravenously every two weeks.

    The infusion continues until the disease progresses or side effects require stopping the medication.

  7. Step 7

    Respiratory safety monitoring

    Throughout the first six months of second‑line treatment, the patient is evaluated regularly for worsening of lung disease.

    If respiratory symptoms worsen enough to require stopping the study medication, treatment is discontinued.

Who can join the trial?

24 criteria

  • Informed, written and signed consent: You must sign a consent form that explains the study, and you must be willing to follow the visit schedule, treatment plan, and lab tests.
  • Your lung cancer must be measurable using standard imaging rules called RECIST criteria (a way doctors track tumor size).
  • Adequate biological function is required, meaning:
    • Kidney function (creatinine clearance) ≥ 45 ml/min.
    • White blood cells (neutrophils) ≥ 1,500 per mm³.
    • Platelet count ≥ 100,000 per mm³.
    • Hemoglobin (red blood cell level) ≥ 9 g/dL.
    • Liver enzymes less than three times the normal upper limit (or less than five times if you have liver metastases).
    • Total bilirubin ≤ 1.5 times the normal limit (or higher limits if you have specific liver conditions).
    • You should have a life expectancy of at least 12 weeks.
    • First‑line only: You must not have received any prior systemic treatment for advanced or metastatic lung cancer. Prior treatment for early‑stage disease is allowed if at least 6 months have passed since the last dose.
    • First‑line only: Any type and any severity of interstitial lung disease (ILD) are allowed.
    • Second‑line only: You must have received exactly one prior platinum‑based chemotherapy for advanced or metastatic disease (again, a 6‑month gap is required after any early‑stage treatment).
    • Second‑line only: Your ILD must be mild‑to‑moderate, defined by:
      • Forced Vital Capacity (FVC) ≥ 50 % of the predicted value (a test that measures how much air you can exhale forcefully).
      • Diffusing capacity for carbon monoxide (DLCO) ≥ 35 % of the predicted value (a test that measures how well oxygen passes from your lungs into the blood).
      • Second‑line only: Acceptable ILD types include idiopathic interstitial pneumonia (such as IPF or NSIP), hypersensitivity pneumonia, pneumoconiosis, and radiation pneumonitis. ILD caused by connective‑tissue diseases (e.g., rheumatoid arthritis, scleroderma) or vasculitis is excluded. Sarcoidosis and interstitial pneumonia with autoimmune features may be considered case‑by‑case.
      • Second‑line only: You must have recent blood tests for a panel of auto‑antibodies (e.g., antinuclear antibodies, rheumatoid factor, anti‑CCP, etc.) to rule out autoimmune causes.
      • If you are a woman who could become pregnant, or have a partner who could become pregnant, you must agree to use highly effective contraception (failure rate < 1 % per year) and continue using it for 7 months after the last study dose. Men must not donate sperm during the study and for 7 months after the last dose, and condoms should always be used.
      • You must be covered by your country’s national health insurance.
      • Adults who are legally protected (e.g., under a guardianship) may join if they can make their own medical decisions as allowed by the guardian.
      • Your ILD must be confirmed by imaging and reviewed by a multidisciplinary ILD board (or a national board if a local one is not available).
      • The lung cancer diagnosis must be proven by tissue (histology) or by a properly prepared cell sample (cytology).
      • You must be 18 years of age or older.
      • Your performance status must be ≤ 2, meaning you are able to care for yourself and perform most daily activities, though you may be unable to work full‑time.
      • Your cancer stage must be IIIB, IIIC (non‑irradiable) or IV according to the 8th edition TNM classification; less advanced stages may be considered if local treatment is not possible.

Who cannot join the trial?

14 criteria

  • Having small cell lung cancer or a tumor that mixes small cell cancer with other types.
  • Having a history of autoimmune diseases (conditions where the body attacks itself), such as myasthenia gravis, myositis, autoimmune hepatitis, inflammatory bowel disease, blood clot problems linked to anti‑phospholipid syndrome, Guillain‑Barré syndrome, multiple sclerosis, vasculitis, or kidney inflammation (glomerulonephritis). This applies only to the second‑line part of the study.
  • Having an interstitial lung disease caused by a connective‑tissue disease, vasculitis, or granulomatosis, including conditions like granulomatosis with polyangiitis, rheumatoid arthritis, Sjögren’s syndrome, scleroderma, myositis/dermatomyositis, or anti‑synthetase syndrome. This applies only to the second‑line part of the study.
  • Having received more than one previous line of cancer treatment. (Second‑line only)
  • Having received any prior immunotherapy (treatments that use the body’s immune system to fight cancer). (Second‑line only)
  • Having had major surgery within the last 3 weeks before the study starts. (Second‑line only)
  • Taking oral steroids (like prednisone) at a dose higher than 10 mg per day, or an equivalent amount of another steroid. (Second‑line only)
  • Taking medicines that suppress the immune system within two weeks before the study starts. (Second‑line only)
  • Having a known activating mutation in the EGFR gene, or a known rearrangement of the ALK or ROS1 genes, which are specific genetic changes in the cancer cells.
  • Having another cancer that is currently active or was treated within the past 3 years, unless it was a very low‑risk skin cancer, cervical cancer in place, or a similar cancer that has a negligible chance of spreading.
  • Having an acute worsening of interstitial lung disease (a sudden flare‑up of lung scarring) in the past 6 months.
  • Having received any previous systemic cancer therapy (such as chemotherapy, targeted therapy, or immunotherapy) before the first‑line part of the study, unless it was an additional (adjuvant) treatment given more than 5 years ago.
  • Having a severe allergy or anaphylactic reaction to laboratory‑made antibodies (chimeric or humanized antibodies) or to any component of the pembrolizumab or nivolumab medicines, including those made in Chinese hamster ovary cells. (Second‑line only)
  • Having interstitial lung disease that shows signs of autoimmunity (called IPAF) according to specific medical criteria. (Second‑line only)
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Investigated drugs

  • Bevacizumab

    is a medicine that helps stop new blood vessels from growing into the tumor. In this study it is given together with carboplatin and paclitaxel to see if adding it improves the treatment for patients with advanced lung cancer and a lung condition called interstitial lung disease.

  • Pembrolizumab

    is an immune‑system drug that helps the body’s own defenses recognize and attack cancer cells. In the trial it is tested as a second‑line option for patients whose disease has come back after earlier treatment, to see how safe it is for people with mild interstitial lung disease.

  • Nivolumab

    works in the same way as pembrolizumab by “releasing the brakes” on the immune system so it can fight the lung cancer. The study uses it as another second‑line choice for patients with advanced disease and non‑severe interstitial lung disease, focusing on its safety for the lungs.

  • Vinorelbine

    is a chemotherapy drug that stops cancer cells from dividing and growing. It may be used as part of the investigator’s choice of chemotherapy in the second‑line part of the trial, allowing researchers to compare its lung safety with other treatments.

  • Gemcitabine

    is a chemotherapy medicine that interferes with the DNA of cancer cells, slowing their growth. In the study it can be selected as the best chemotherapy option for patients receiving second‑line treatment, and its effect on lung toxicity will be observed.

  • Pemetrexed

    is a chemotherapy drug that blocks the building blocks cancer cells need to make new DNA. It may be chosen as part of the second‑line chemotherapy arm of the trial, and its safety for patients with interstitial lung disease will be monitored.

What is already known about the treatment

  • BEVACIZUMAB

    This drug is given by slow intravenous drip. It is an approved cancer medicine used mainly for lung and other solid tumors. It works by attaching to a protein called VEGF, which stops new blood vessels from feeding the tumor. It is classified as an anti‑angiogenic monoclonal antibody.

  • PEMBROLIZUMAB

    Pembrolizumab is administered through an intravenous infusion. It is a widely approved immunotherapy for many cancers, including non‑small cell lung cancer. It blocks a checkpoint called PD‑1 on immune cells, helping the body’s own defenses recognize and attack cancer cells. It belongs to the class of PD‑1 checkpoint inhibitor antibodies.

  • VINORELBINE

    Vinorelbine is delivered by intravenous injection. It is an established chemotherapy drug for lung cancer and some other cancers. It interferes with the building blocks of cell division, stopping cancer cells from multiplying. It is classified as a vinca‑alkaloid antineoplastic agent.

  • GEMCITABINE

    Gemcitabine is given as an intravenous infusion. It is an approved treatment for several cancers, including lung, pancreas and breast cancers. It mimics a building block of DNA, causing the cancer cell’s DNA to break during replication. It is classified as a nucleoside analog chemotherapy.

  • NIVOLUMAB

    Nivolumab is administered by intravenous infusion. It is an approved immunotherapy for many cancers, such as lung cancer and melanoma. It blocks the PD‑1 checkpoint on immune cells, allowing the immune system to attack the tumor. It belongs to the PD‑1 checkpoint inhibitor antibody class.

  • PEMETREXED

    Pemetrexed is given through an intravenous infusion. It is an approved chemotherapy for non‑small cell lung cancer and mesothelioma. It stops cancer cells from making DNA and proteins needed for growth. It is classified as an antifolate antineoplastic agent.

Investigated diseases

  • Non‑small cell lung cancer

    This disease is a type of lung cancer that begins when abnormal cells grow in the lining of the airways. The tumor usually starts small and may enlarge slowly within the lung. Over time it can spread to nearby lung tissue, lymph nodes, or other organs. As the growth continues, it can cause coughing, shortness of breath, and reduced lung function.

  • Interstitial lung disease

    This condition involves inflammation and scarring of the lung tissue surrounding the air sacs. It often starts with mild irritation that can progress to thickening and stiffening of the walls of the air sacs. The scarring reduces the lungs’ ability to exchange oxygen and carbon dioxide, leading to increasing difficulty breathing. Symptoms may develop gradually and become more noticeable as the disease advances.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-522790-10-00Protocol codeIFCT-2502Estimated enrolment108 patientsSponsorIntergroupe Francophone De Cancerologie Thoracique

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