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Durvalumab after chemoradiation for patients with limited‑stage small cell lung cancer: a randomized trial of high‑dose versus standard thoracic radiation

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What is this trial about?

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

The disease being studied is small-cell lung cancer that is limited stage. This type of lung cancer grows quickly and is usually found only in the chest. The treatment plan includes a combination of chemotherapy, radiation, and an immune‑system drug. First, patients receive platinum/etoposide chemotherapy, which uses medicines to kill rapidly dividing cancer cells. After chemotherapy, a high dose of radiotherapy is given twice a day to the chest to target the tumor. Following radiation, patients receive an infusion of the immune‑boosting drug durvalumab, which helps the body’s own defenses recognize and attack cancer cells.

The purpose of the study is to see whether a higher radiation dose improves overall survival. Participants will be randomly assigned to receive either the standard radiation dose or a higher dose, then all will continue with the same durvalumab treatment. The study follows patients for several months, checking how long they live, how the cancer responds, any side effects, and how they feel in daily life.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Randomization to radiation dose group
After enrollment, you will be assigned by the study to receive one of two radiation dose levels: either 60 gy or 45 gy. gy stands for gray, a unit that measures the amount of radiation delivered.
The assignment is done by the study and you will not choose the dose.
Step 2
Concurrent chemotherapy and thoracic radiotherapy
You will begin a treatment that combines platinum‑based chemotherapy with the drug etoposide and thoracic radiotherapy that is given twice each day.
The radiotherapy will be delivered to the chest area at the dose level assigned in step 1.
The chemotherapy and radiotherapy are given together over several weeks according to the study schedule.
Step 3
Start of durvalumab infusion
Once the combined chemotherapy and radiotherapy are finished, you will receive the medication durvalumab.
Durvalumab is supplied as a solution for infusion and is given by intravenous (iv) infusion.
Each infusion contains a dose of 1500 mg of durvalumab.
Step 4
Continued durvalumab therapy
You will continue to receive durvalumab infusions for the period defined by the study protocol.
Each infusion will be administered by iv according to the schedule set by the trial.
Step 5
Follow‑up assessments
Throughout the durvalumab treatment and after it ends, you will have regular visits to check your overall health, lung status, and any side effects.
The study will collect information on overall survival, tumor control in the chest, time until durvalumab is stopped, side effects, response of the cancer, progression‑free survival, and quality of life.

Who can join the trial?

21 criteria

There must be no cancer cells in the fluid around the lungs (pleural fluid). If fluid is present, a sample will be tested, but if there isn’t enough fluid for testing, you can still be eligible.
You must be able to receive twice‑daily radiation therapy (BID) of either 60 Gy or 45 Gy to all tumor sites, even if you have had radiation to the chest before.
Your overall health level, measured as ECOG performance status, must be between 0 and 2 (able to care for yourself and carry out daily activities with little or no limitation).
Your cancer must be measurable on scans using the standard criteria called RECIST 1.1, taken before chemotherapy starts.
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Your organs must work well enough before chemotherapy, including:
- Liver enzyme ALT no higher than 2.5 times the normal limit.
- Total bilirubin (a liver waste product) no higher than 1.5 times the normal limit.
- Hemoglobin (the protein that carries oxygen in blood) at least 9.0 g/dL.
- White blood cells called neutrophils at least 1.5 × 10⁹ per liter.
- Platelets (cells that help blood clot) at least 100 × 10⁹ per liter.
- Kidney function: creatinine less than 125 µmol/L and a filtration rate (GFR) greater than 50 ml/min, measured by a standard test or calculated with the Cockcroft‑Gault formula.
- You must be awake, understand the study, and be able to sign a consent form yourself.
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  Your lung function must be adequate:
  - Forced expiratory volume in one second (FEV1) greater than 1 liter or more than 30 % of what is expected for your age and size.
  - Diffusing capacity of the lungs for carbon monoxide (DLCO) greater than 30 % of the expected value.
  - If lower numbers are caused by the tumor pressing on the airway, you can still be eligible.
  - If you are a woman who could become pregnant, you must use a highly effective birth control method (such as a vasectomy, tubal ligation, intrauterine device, hormonal implant, patch, or pills) and avoid pregnancy during treatment and for at least 5 months after the last dose.
  - You need to have a life expectancy of at least 12 weeks.
  - You must be willing and able to follow the study schedule, including all treatments, visits, and follow‑up examinations.
  - You must be at least 18 years old (or at least 20 years old for Japanese participants).
  - Your body weight must be more than 30 kg (about 66 lb).
  - You must have a diagnosis of small‑cell lung cancer confirmed by tissue or cell analysis. If the tumor contains other cell types, the small‑cell component must be at least 90 % of the tumor.
  - Your cancer must be stage I‑III (according to the TNM version 9 system) and not be suitable for surgery.

Who cannot join the trial?

20 criteria

You have taken part in another clinical study that used an experimental drug within the last 30 days.
You received a live‑attenuated vaccine (a vaccine that contains weakened live germs) within 30 days before your first dose of durvalumab, or you would need to receive such a vaccine while on durvalumab or up to 30 days after the last dose.
You are allergic to any of the study medicines or to any inactive ingredients (excipients) in those medicines.
You are enrolled in another clinical study at the same time, unless that study only observes patients without giving any treatment (observational) or is a follow‑up after a previous interventional study. Participation in the PRIMALung and MAVERICK studies is allowed.
You have already had chemotherapy or radiation treatment for small‑cell lung cancer.
You have previously received a checkpoint inhibitor drug (a type of immunotherapy) such as durvalumab.
You have a pathological pericardial effusion (fluid buildup around the heart that is caused by disease).
You had a major surgery within the past 28 days before starting the study treatment (minor local surgery for diagnosis or symptom relief is allowed).
You have a history of receiving an allogenic stem‑cell or organ transplant (transplant from another person).
You have an active or past autoimmune or inflammatory disorder, such as inflammatory bowel disease (e.g., colitis or Crohn’s disease), diverticulitis, systemic lupus erythematosus, sarcoidosis, Wegener’s granulomatosis, Graves’ disease, rheumatoid arthritis, hypophysitis, uveitis, or similar conditions, unless you meet one of the listed exceptions.
You have a history of lung diseases such as idiopathic pulmonary fibrosis, interstitial lung disease, organizing pneumonia (e.g., bronchiolitis obliterans), drug‑induced lung inflammation, or you have active lung inflammation (pneumonitis) seen on a CT scan before chemotherapy.
You have an uncontrolled illness, such as an ongoing infection, symptomatic heart failure, high blood pressure that is not controlled, unstable chest pain (unstable angina), irregular heart rhythm, a prolonged QTc interval on an ECG (>470 ms), serious chronic stomach or intestinal problems causing diarrhea, or a psychiatric or social condition that would make it hard to follow the study rules or give proper consent.
You are pregnant or breastfeeding.
You have another primary cancer (including blood cancers), except if it was treated with curative intent and has been disease‑free for at least 5 years, or if it is a localized breast or prostate cancer treated only with hormone therapy, or a treated non‑melanoma skin cancer that shows no current disease, or a low‑risk cancer unlikely to need systemic therapy.
You are currently receiving any chemotherapy, experimental drug, biologic therapy, or hormonal therapy for cancer, except for hormone therapy alone for localized breast or prostate cancer.
You still have unresolved side effects from previous cancer treatment that are grade 2 or higher (moderate or worse) according to the NCI CTCAE grading system, except for hair loss, vitiligo, or certain lab values. Severe nerve damage (neuropathy) will be considered individually.
You have a history of an active primary immunodeficiency (a condition that weakens the immune system).
You have tested positive for HIV (human immunodeficiency virus) antibodies.
You have an active infection such as tuberculosis, hepatitis B (positive surface antigen), or hepatitis C, unless the hepatitis B infection is resolved or hepatitis C RNA is negative.
You are currently or have previously used immunosuppressive medicines, except for limited use of nasal, inhaled, topical steroids, low‑dose systemic steroids (≤10 mg prednisone daily), steroids given before certain procedures, steroids used to reduce tumor‑related swelling, or preventive steroids related to chemotherapy.

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Verified sites

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

Responsive
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, The Netherlands
Responsive
North Estonia Medical Centre Foundation
Tallin, Estonia
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Universitetssykehuset Nord-Norge HF
Tromsø, Norway

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Investigated drugs

Durvalumab
is an immunotherapy drug that helps the body’s immune system find and fight cancer cells. In this study it is given through an IV infusion after patients have completed chemotherapy and radiation, with the goal of keeping the cancer from coming back.
Platinum‑based chemotherapy
(such as carboplatin or cisplatin) is a type of chemotherapy that damages the DNA inside cancer cells, making it harder for them to grow and divide. It is given by IV together with another chemotherapy drug and is part of the initial treatment before the immunotherapy starts.
Etoposide
is another chemotherapy medication that stops cancer cells from copying their DNA, which slows or stops tumor growth. Like the platinum drug, it is administered through an IV as part of the combined chemotherapy regimen.
Thoracic radiotherapy
is a treatment that uses high‑energy X‑rays aimed at the chest where the lung tumor is located. In this trial patients receive radiation twice a day, and the study compares a higher total dose (60 Gy) with a lower dose (45 Gy) to see which improves survival.

Durvalumab

What is already known about the treatment

Durvalumab - This medication is administered as an intravenous infusion, where a solution is slowly injected into a vein using a drip. It is an approved cancer drug that is widely used and studied in medical literature, especially for lung cancers. The main use is to help the immune system fight small‑cell lung cancer after patients have received chemotherapy and radiation. It works by blocking a protein called PD‑L1 on cancer cells, which lets the body’s immune cells recognize and attack the tumor, and it belongs to the class of immune checkpoint inhibitors.

Investigated diseases

Limited-stage small-cell lung cancer - Small-cell lung cancer is a fast‑growing cancer that starts in the lung’s airway cells. In the limited stage, the disease is confined to one side of the chest and may involve nearby lymph nodes. It can spread within the chest and to nearby structures over time. Without control, the cancer may extend beyond the original area to distant organs. The disease often shows rapid changes in size and location as it advances.