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Durvalumab versus standard chemotherapy drug combination in elderly patients with advanced 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

The study focuses on patients with advanced non-small cell lung cancer, a type of lung cancer that has spread beyond the lungs. Two treatment strategies are being compared. One strategy starts with the immune‑boosting drug durvalumab (an immunotherapy) and switches to standard chemotherapy if the disease gets worse. The chemotherapy regimen may include medicines such as vinorelbine, pemetrexed, carboplatin, cisplatin, paclitaxel or gemcitabine, which are given through a vein.

The purpose of the study is to compare how well the two approaches work and how safe they are in older patients whose tumors have a high level of the protein PDL1 or an unknown level. Participants are randomly assigned to receive either the immunotherapy‑first plan or the chemotherapy‑first plan, and the assigned treatment is continued until the disease progresses or side effects become unacceptable, after which the other treatment is started. The study follows patients for at least a year to see how many are alive after 12 months and also records early deaths within four months.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization

    After enrollment, the patient is randomly assigned to one of two treatment arms. the assignment determines whether the first medication is durvalumab (immunotherapy) or a standard chemotherapy regimen.

  2. Step 2

    First‑line treatment – durvalumab arm

    If assigned to the durvalumab arm, the patient receives durvalumab 1500 mg by intravenous infusion. intravenous means the drug is delivered into a vein through a needle or catheter.

    The dose of 1500 mg is given as a single administration each cycle; the exact interval between cycles follows the study protocol (not specified in the source).

    Treatment continues until disease progression is documented or until the study ends.

  3. Step 3

    First‑line treatment – chemotherapy arm

    If assigned to the chemotherapy arm, the patient receives a standard chemotherapy regimen that may include one or more of the following drugs at the doses listed:

    vinorelbine 30 mg/m² intravenously,

    pemetrexed disodium 500 mg/m² intravenously,

    carboplatin 450 mg intravenously,

    cisplatin 60 mg/m² intravenously,

    paclitaxel 90 mg/m² intravenously,

    gemcitabine hydrochloride 1200 mg/m² intravenously.

    The unit mg/m² (milligram per square meter) adjusts the dose to the patient’s body surface area, which is calculated from height and weight.

    Each drug is administered by intravenous infusion according to the schedule defined by the study (frequency not specified).

    Treatment is continued until disease progression is documented or until the study ends.

  4. Step 4

    Regular monitoring visits

    Throughout first‑line treatment, the patient attends scheduled clinic visits for physical examination, laboratory tests, and imaging studies to evaluate response and safety.

    Any side effects are recorded and managed according to standard clinical practice.

  5. Step 5

    Assessment of disease progression

    If imaging or clinical evaluation shows that the cancer has progressed, the patient moves to the second‑line treatment phase as defined by the study.

  6. Step 6

    Second‑line treatment – switch therapy

    Patients who received durvalumab as first‑line therapy start the standard chemotherapy regimen described in step 3.

    Patients who received chemotherapy as first‑line therapy start durvalumab 1500 mg intravenously, following the same administration principles as in step 2.

    The same monitoring procedures are applied during second‑line therapy.

  7. Step 7

    Continued follow‑up

    The patient continues to attend regular visits for safety checks, laboratory tests, and imaging until the end of the study period or until further disease progression.

    Survival status is recorded at 12 months after randomization, and mortality within the first 4 months is specifically noted as a safety outcome.

  8. Step 8

    Study completion

    At the end of the study, all collected data on survival, disease progression, quality of life, and side effects are analyzed to determine the effectiveness and safety of the treatment strategies.

Who can join the trial?

15 criteria

  • Age: You must be 70 years old or older, regardless of gender.
  • Diagnosis: You need a confirmed diagnosis of primary squamous or non‑squamous non‑small cell lung cancer (a common type of lung cancer).
  • Cancer stage: Your cancer must be at stage IV or IIIC and have spread to lymph nodes above the collarbone (called supraclavicular nodes).
  • PD‑L1 level: Your tumor cells must show a PD‑L1 protein expression of 25% or higher, or the test result may be unavailable (only a small number of participants can have an unknown result). PD‑L1 is a protein that helps doctors decide which treatments may work best.
  • Evidence of disease: There must be a clear sign of cancer on scans or physical exam, with at least one spot that can be measured or not measured.
  • ECOG performance status: You must have a status of 0 or 1, meaning you are fully active or able to do light work.
  • Life expectancy: You should be expected to live longer than 3 months.
  • Kidney and liver health: Your blood tests must show:
    • Total bilirubin ≤ 1.5 times the normal upper limit.
    • AST and/or ALT ≤ 2.5 times the normal upper limit (or ≤ 5 times if you have liver metastases).
    • Serum creatinine ≤ 1.5 times the normal upper limit (or a calculated creatinine clearance of at least 40 mL/min/1.73 m²).
    • Bone‑marrow health: Your blood counts must be:
      • Hemoglobin ≥ 9.0 g/dL (measure of red blood cells).
      • Absolute neutrophil count ≥ 1.5 × 10⁹/L (type of white blood cell).
      • Platelet count ≥ 100 × 10⁹/L (helps blood clot).
      • Informed consent: You must sign a written consent form before any study procedures are done.
      • Patients whose tumors have PD‑L1 ≥ 50% are usually treated with a different standard therapy and are not encouraged to join this study.

Who cannot join the trial?

22 criteria

  • Activating EGFR mutation: having a specific change in the epidermal growth factor receptor gene (such as exon 19 deletion or exon 21 L858R) that can make the cancer grow faster.
  • ALK or ROS1 positive: test results show the cancer cells have ALK or ROS1 gene changes, identified by special lab techniques (immunohistochemistry or FISH).
  • Mixed small‑cell lung cancer and NSCLC: the tumor contains both small‑cell lung cancer and non‑small cell lung cancer cells.
  • Previous chemotherapy or other treatment for advanced lung cancer: you have already received chemotherapy or other medicine for advanced disease (except chemotherapy given more than six months ago as part of earlier surgery).
  • Prior immunotherapy: you have previously received drugs that affect the immune system, such as anti‑PD‑1, anti‑PD‑L1, or anti‑PD‑L2 antibodies.
  • Recent use of immunosuppressive medication: you have taken medicines that suppress the immune system within 14 days before the first study dose (low‑dose steroids up to 10 mg prednisone per day are allowed).
  • Concurrent investigational product: you are currently receiving any other experimental drug or cancer treatment.
  • Active or recent autoimmune disease: you have an immune‑system disease that was active or diagnosed in the past two years (exceptions are vitiligo, Graves’ disease, or psoriasis that did not need systemic treatment).
  • Inflammatory bowel disease: you have Crohn’s disease or ulcerative colitis, which are chronic inflammation of the intestines.
  • History of organ transplant: you have received a donor organ from another person (allogeneic transplant).
  • Primary immunodeficiency: you have a condition that makes your immune system weak from birth or early life.
  • Active infections: you have a current infection such as tuberculosis, hepatitis B (positive surface antigen), hepatitis C, or HIV (positive antibody test).
  • Recent live vaccine: you received a live‑attenuated vaccine (a vaccine containing weakened virus) within 30 days before the first study dose.
  • Recent other cancers: you have had another cancer in the past five years, except for certain skin cancers, cervical carcinoma in situ, or surgically removed prostate cancer with a normal PSA test.
  • Brain or spinal cord involvement: you have cancer that has spread to the brain or is compressing the spinal cord, unless it is symptom‑free, previously treated, and you have been off steroids and seizure medicines for at least one month.
  • Leptomeningeal carcinomatosis: cancer cells are present in the membranes surrounding the brain and spinal cord.
  • Recent heart attack or unstable chest pain: you have had a myocardial infarction (heart attack) or unstable angina within the past six months.
  • Significant heart failure: you have congestive heart failure that is New York Heart Association (NYHA) class II or worse.
  • Uncontrolled high blood pressure: your blood pressure is not adequately controlled with medication.
  • Serious heart rhythm problems: you need medication for a dangerous heart arrhythmia (except atrial fibrillation or brief fast heart rhythms that are not considered serious).
  • Severe peripheral vascular disease: you have blood vessel disease in the limbs that is grade 3 or higher, meaning it causes symptoms that limit daily activities and may need surgery.
  • Prolonged QT interval: your heart’s electrical recovery time (QTc) is 470 milliseconds or longer on an electrocardiogram, indicating a risk of abnormal heart rhythms.
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Investigated drugs

  • Durvalumab

    is an immunotherapy drug that helps the body’s immune system see and attack lung cancer cells. In this study it is given through an IV. In the experimental group, patients receive durvalumab as the first treatment. In the standard‑treatment group, patients receive the same drug after their cancer gets worse on chemotherapy.

  • Vinorelbine

    is a chemotherapy medicine that stops cancer cells from dividing. It is given by IV and is used as part of the standard chemotherapy regimen in the control arm of the trial.

  • Pemetrexed

    is a chemotherapy drug that blocks the enzymes cancer cells need to make new DNA. It is administered intravenously and is included in the standard chemotherapy combinations given to patients in the control group.

  • Carboplatin

    is a platinum‑based chemotherapy that damages the DNA of cancer cells, preventing them from growing. It is given by IV and forms part of the standard chemotherapy regimen used in the control arm.

  • Cisplatin

    is another platinum‑based chemotherapy that works by harming the DNA of cancer cells. It is delivered intravenously and is one of the chemotherapy agents used in the standard treatment group.

  • Paclitaxel

    is a chemotherapy drug that freezes the structures (microtubules) that cancer cells need to split and multiply. It is given through an IV and is included in the standard chemotherapy regimen for the control arm.

What is already known about the treatment

  • Vinorelbine

    Vinorelbine is administered by slow intravenous injection and is an approved chemotherapy for advanced non‑small cell lung cancer. It belongs to the vinca‑alkaloid class of antimitotic agents. It stops cancer cells from dividing by preventing the formation of microtubules, which are essential for cell division. It is commonly used in combination with other lung‑cancer drugs.

  • Durvalumab

    Durvalumab is given as an intravenous infusion and is a licensed immunotherapy for non‑small cell lung cancer with high or unknown PD‑L1 expression. It is classified as a PD‑L1 checkpoint inhibitor. It works by blocking the PD‑L1 protein on tumor cells, allowing the immune system to recognize and attack the cancer. It is used as a first‑line or subsequent treatment in advanced lung cancer.

  • Pemetrexed

    Pemetrexed is delivered by intravenous infusion and is an approved chemotherapy for advanced non‑small cell lung cancer, often used together with platinum drugs. It is an antifolate agent. It interferes with enzymes needed to make DNA and RNA, which stops cancer cells from growing. It is a standard part of many lung‑cancer treatment regimens.

  • Carboplatin

    Carboplatin is given by intravenous infusion and is an approved platinum‑based chemotherapy for advanced non‑small cell lung cancer. It belongs to the class of platinum compounds. It creates cross‑links in the DNA of cancer cells, which prevents them from replicating and leads to cell death. It is frequently combined with other chemotherapy drugs.

  • Cisplatin

    Cisplatin is administered intravenously and is a long‑standing, approved platinum chemotherapy for advanced non‑small cell lung cancer. It is a platinum‑based antineoplastic agent. It binds to DNA and forms cross‑links that block DNA replication, causing cancer cells to die. It remains a backbone drug in many lung‑cancer treatment plans.

  • Paclitaxel

    Paclitaxel is given by intravenous infusion and is an approved chemotherapy for advanced non‑small cell lung cancer. It is classified as a taxane. It stabilizes microtubules, preventing them from breaking down, which stops cancer cells from completing division. It is often used in combination with other lung‑cancer drugs.

Investigated diseases

Non‑small cell lung cancer - It is a type of lung cancer that begins in the cells lining the airways. The tumor usually grows slower than small‑cell lung cancer and can spread locally within the lung. In advanced stages, the disease extends beyond the lung to nearby lymph nodes or distant organs. As it progresses, symptoms such as persistent cough, shortness of breath, and weight loss may appear. The cancer cells continue to multiply and invade surrounding tissue over time.
Trial detailsLast updated 2 Oct 2026
Age65+ yearsPhasePhase IITrial ID2024-515326-83-00Protocol codeMILES-5Estimated enrolment240 patientsSponsorIRCCS Istituto Nazionale Tumori Fondazione Pascale

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).