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Durvalumab personalized consolidation immunotherapy after chemoradiotherapy in patients with stage III 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 stage III non-small cell lung cancer, a type of lung cancer that has grown locally but has not spread to distant parts of the body. Standard treatment for this condition often includes chemoradiotherapy, which combines chemotherapy (medicine that kills cancer cells) and radiation therapy (high‑energy rays that damage cancer cells). After completing this initial therapy, participants receive a personalized form of consolidation immunotherapy. The medication used is IMFINZI, whose active ingredient is durvalumab, given by intravenous infusion (a drip placed into a vein). Before starting the immunotherapy, a blood test looks for MRD, short for minimal residual disease, meaning any tiny amount of cancer that might still be present.

The purpose of the study is to see whether this personalized approach can keep the cancer from coming back and improve overall health. After the MRD test, the infusion is given at regular intervals for several months, and participants return for routine visits where doctors check for side effects, ask about daily well‑being, and collect information on overall health status. The study follows participants for about a year to monitor how well the cancer stays under control and how the treatment affects quality of life.

The research process

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

Step 1
Enrollment and randomization
After signing consent, you are assigned a study group by random selection.
Step 2
Baseline assessments
A series of tests, such as imaging scans and blood samples, are performed to record the current status of your disease.
Step 3
Start of consolidation immunotherapy
You receive durvalumab (brand name imfinzi) at a dose of 1500 mg.
The medication is given as an intravenous infusion, meaning it is delivered through a vein over a period of time.
Step 4
Regular infusion visits
You attend the clinic for each infusion according to the schedule defined by the study, typically every few weeks.
Each visit includes monitoring of vital signs and assessment for any side effects.
Step 5
Monitoring and safety assessments
Periodic blood tests and imaging are performed to evaluate disease progression and to detect any adverse events.
Adverse events are graded using a standardized scale (nci ctcae v6.0), which classifies side effects from mild to severe.
Step 6
Quality‑of‑life questionnaires
You complete the qlq‑c30, qlq‑lc29, and eq‑5d‑5l questionnaires at designated visits to report your overall well‑being.
Step 7
End of treatment and follow‑up
Treatment may continue for up to 12 months from the first infusion.
After the last infusion, you continue to be followed for survival and disease status according to the study schedule.

Who can join the trial?

15 criteria

Informed consent: You must sign a written consent form before any study procedures begin.
You must be willing and able to attend scheduled visits, follow the treatment schedule, and have required lab tests.
Kidney function: Your creatinine clearance must be at least 45 mL/min (a test that shows how well your kidneys filter waste).
Women who could become pregnant must have a negative pregnancy test within 14 days before the first treatment day.
Women who could become pregnant must either avoid sexual intercourse or use birth control methods that fail less than 1 % of the time (such as tubal ligation, male sterilization, hormonal pills, hormone‑releasing or copper intrauterine devices). They must use these methods during treatment and for at least 7 months after the last dose, and must not donate eggs.
Men with partners who could become pregnant must avoid sexual intercourse or use a condom during treatment and for at least 6 months after the last dose, and must not donate sperm.
You must have national health insurance coverage.
You must be 18 years of age or older.
ECOG Performance Status of 0 or 1 (a simple scale that measures how well you can carry out daily activities; 0 means fully active, 1 means restricted in physically strenuous activity but able to do light work).
You must have a tissue diagnosis confirming unresectable locally advanced stage III non‑small cell lung cancer.
A tumor tissue sample must be available for molecular testing.
The tumor must be measurable according to RECIST 1.1 (a standard system doctors use to measure tumor size on scans).
You must be eligible for combined chemo‑radiation therapy (CRT) with at least two cycles of induction chemotherapy before CRT, and must receive a minimum radiation dose of 60 Gy covering at least 95 % of the tumor.
Lung function: FEV1 must be at least 40 % of the predicted value (the amount of air you can forcefully exhale in one second) and arterial oxygen pressure (PaO2) must be at least 60 mmHg (a measure of oxygen level in your blood).
Blood counts must meet the following: neutrophils (PNN) ≥ 1.5 × 10⁹/L, platelets ≥ 100 × 10⁹/L, and hemoglobin ≥ 9 g/dL (these are numbers that show you have enough white blood cells, platelets, and oxygen‑carrying protein).

Who cannot join the trial?

15 criteria

Having a known EGFR or HER2 gene change that drives the tumor (specific mutations such as deletion LREA in exon 19, L858R or L861X in exon 21, G719A/S in exon 18, or insertions in exon 20), whether found in tissue or blood.
Being pregnant or breastfeeding.
Being under legal protection (for example, having a court‑appointed guardian).
Being unable to follow the requirements and procedures of the trial.
Taking systemic corticosteroid medication higher than 10 mg per day of prednisone (or an equivalent dose) or other drugs that suppress the immune system, except for extra hydrocortisone that may be needed.
Having an autoimmune disease, except for well‑controlled thyroid hormone replacement, stable type 1 diabetes, or skin conditions such as vitiligo, psoriasis, or lichen that do not affect other organs.
Having previously received cancer treatment with an immune checkpoint inhibitor (a type of immunotherapy drug).
Having a known ALK or ROS1 gene rearrangement, as identified by special laboratory tests (immunohistochemistry, FISH, or NGS).
Receiving chemotherapy first and then radiation later (called sequential CRT), instead of the combined approach used in the study.
Having cancer that involves the lining of the lungs (pleural involvement) or tumors that have spread outside the chest (extra‑thoracic lesions).
Having other medical conditions that make combined chemoradiation unsafe.
Having significant signs of interstitial lung disease on a chest CT scan or a confirmed diagnosis of this lung condition.
Having another cancer diagnosed within the past three years, or having an active cancer now, except for basal cell skin cancer or early‑stage cervical cancer (carcinoma in situ).
Having had radiation treatment to the chest before.
Having had chemotherapy within the past three years.

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Verified sites

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

Assistance Publique Hopitaux De Marseille
Verified
Marseille, France
Assistance Publique Hopitaux De Paris
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Paris, France
CHU Grenoble Alpes
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La Tronche, France

Trial locations

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Investigated drugs

Chemoradiotherapy, often called CRT, is a combined treatment that uses chemotherapy drugs together with radiation therapy. In this study, patients with stage III non‑small cell lung cancer first receive CRT to shrink or eliminate the tumor before any further therapy is given.

durvalumab is an immunotherapy medicine that is given by IV infusion after the chemoradiotherapy is finished. It works by helping the body’s immune system find and destroy any cancer cells that may still be present, aiming to keep the cancer from coming back.

Durvalumab

What is already known about the treatment

Durvalumab - It is given as an intravenous infusion of a clear solution, usually over about an hour. Durvalumab is an approved and well‑studied drug used in cancer care, especially after chemoradiotherapy for stage III non‑small cell lung cancer. It works by binding to the PD‑L1 protein on cancer cells, blocking the signal that tells the immune system to stand down, allowing the body’s own defenses to attack the tumor. Durvalumab is classified as an immune‑checkpoint inhibitor and is a monoclonal antibody.

Investigated diseases

Stage III non‑small cell lung cancer - It is a cancer that starts in the larger airways of the lungs and has grown into nearby lymph nodes or chest structures without spreading to distant organs. The tumor usually grows slowly and may cause a persistent cough, shortness of breath, or chest discomfort. As the disease advances, the mass can become larger and involve more of the lung tissue and surrounding mediastinal nodes. It may also invade the chest wall, diaphragm, or major blood vessels within the chest cavity. Over time, the affected area can expand, leading to increased respiratory symptoms.