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Phase II Randomized Trial of Adjuvant Durvalumab Immunotherapy After Neoadjuvant Chemoimmunotherapy in Patients With Resectable Non‑Small Cell Lung Cancer

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

In this study, adults with Non Small Cell Lung Cancer that can be removed by surgery are being examined. After an initial round of chemotherapy combined with an immune‑boosting drug (known as neoadjuvant chemoimmunotherapy), patients undergo surgery to take out the tumor. Following surgery, participants are randomly assigned to receive either an intravenous infusion of durvalumab as adjuvant immunotherapy or a placebo, with the goal of seeing whether this additional treatment can improve the length of time patients remain free of cancer, called disease-free survival. The study’s purpose is to compare how long patients stay cancer‑free after the two different post‑surgery approaches.

After the surgery, patients receive the assigned infusion every few weeks for several months and attend regular check‑ups where doctors look for any signs that the cancer has returned. Blood samples are taken to test for ctDNA, which are tiny fragments of tumor DNA that can appear in the bloodstream and may signal a recurrence. Participants also complete questionnaires that assess their overall well‑being, including their quality of life and any difficulty breathing, known as dyspnoea. The study follows each person for several years to record any return of cancer, overall health status, and any side effects that may arise.

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 in the trial
After providing informed consent, you become a participant in the study and receive a study identification number.
Step 2
Surgical removal of the lung tumor
The tumor that was treated with neoadjuvant chemoimmunotherapy is surgically removed.
The date of surgery marks the start of the adjuvant phase of the trial.
Step 3
First dose of adjuvant immunotherapy
You receive imfinzi, a solution for infusion that contains the active substance durvalumab.
The dose is 1500 mg, administered as an intravenous infusion (infused into a vein).
The infusion is given in a clinical setting under the supervision of study staff.
Step 4
Repeated immunotherapy infusions
Additional infusions of imfinzi are given repeatedly according to the study schedule.
Each infusion uses the same dose of 1500 mg given by intravenous infusion.
The exact interval between infusions and total number of cycles are defined in the trial protocol.
Step 5
Regular safety and disease monitoring visits
Between infusion visits you attend clinic appointments for safety checks, blood tests, and imaging as required by the protocol.
These visits help the study team evaluate any side effects and monitor the status of the disease.
Step 6
Assessment at 12 months after surgery
Approximately one year after the surgery, specific evaluations are performed:
ctDNA testing to detect circulating tumor DNA,
Questionnaires that measure health‑related quality of life,
Assessment of dyspnoea (shortness of breath).
Step 7
Long‑term follow‑up for disease‑free survival
The study continues to follow you for up to 36 months after the last patient has been enrolled.
During this period, information on disease‑free survival (time from surgery to any cancer recurrence or death related to lung cancer) is collected.
Additional visits may be scheduled to record overall survival and any late side effects.

Who can join the trial?

11 criteria

You must be at least 18 years old when you sign the study consent form.
Your body weight must be more than 30 kilograms (about 66 pounds).
You need to be willing and able to follow all study instructions, attend scheduled visits, and have any required examinations and follow‑up.
You must have stage II‑III non‑small cell lung cancer (NSCLC) that doctors consider to have a high chance of coming back after treatment.
The doctors must believe that the tumor can be completely removed with clean margins, called an R0 resection, which means no cancer cells are left at the edges of the removed tissue.
Your overall health level, measured by the ECOG performance status, must be 0 or 1 (able to carry out normal activities without significant limitation).
Tests must show that you do not have the genetic changes called ALK or EGFR. Having a positive KRAS mutation is used as a sign that ALK and EGFR are negative.
You must be considered operable by a team of doctors, meaning surgery is a suitable option according to national guidelines.
If you are a woman who could become pregnant, you must use a highly effective birth‑control method during treatment and for at least five months after the last dose. Effective methods include hormonal pills, patches, injections, implants, intrauterine devices, tubal ligation, a partner’s vasectomy, or agreed‑upon abstinence.
You must be able to give written, signed informed consent, which means you understand the study and agree to follow its rules.
Your blood and organ tests must show that your organ and bone‑marrow function are adequate for the study, as defined by the trial protocol.

Who cannot join the trial?

24 criteria

Medically inoperable – the cancer cannot be removed safely by surgery.
Recent use of other experimental medicines – taking any study drug that might affect the trial drug within the last month (or longer if the drug stays in the body for a long time).
Enrolled in another clinical trial – being part of a different research study at the same time, unless it is only observational (does not involve treatment) or you are in the follow‑up phase of a previous trial.
History of another primary cancer – having had a different cancer previously, except if it was treated with curative intent and has been disease‑free for at least three years, or if it was a non‑melanoma skin cancer, carcinoma in situ, low‑grade prostate cancer, or similar low‑risk conditions.
Targetable EGFR or ALK mutations – known genetic changes in the tumor (EGFR or ALK) that can be treated with specific drugs.
Live vaccine within 30 days – receiving a vaccine that contains a weakened live virus (e.g., certain flu or yellow fever shots) within the month before starting the study drug. Non‑live COVID‑19 vaccines are allowed.
Active or past autoimmune/inflammatory disease – conditions where the immune system attacks the body (such as ulcerative colitis, Crohn’s disease, lupus, sarcoidosis, rheumatoid arthritis, etc.), unless the disease is mild, well‑controlled, or meets specific exceptions (e.g., vitiligo, stable hypothyroidism, controlled celiac disease).
Uncontrolled illness that would stop chemotherapy or immunotherapy – ongoing infections, severe heart failure, uncontrolled high blood pressure, unstable chest pain, dangerous heart rhythm, lung disease, serious gut problems causing diarrhea, or psychiatric/social issues that would prevent safe study participation.
Active primary immunodeficiency – a disorder that makes the immune system unable to fight infections normally.
Active hepatitis infection – current infection with hepatitis B or C viruses as shown by blood tests (specific virus markers are positive).
Co‑infection with hepatitis B and C or hepatitis B and D – having both hepatitis B and another hepatitis virus at the same time.
Pregnancy or breastfeeding – being pregnant or feeding a baby.
HBV infection requiring antiviral therapy – hepatitis B virus present with a high level of virus in the blood, needing antiviral medication and viral suppression before joining the study.
HBV infection without active virus – hepatitis B virus present but with undetectable levels, allowing enrollment but requiring regular monitoring.
HIV infection that is not well controlled – HIV infection where the virus is still detectable, CD4 count is low, recent serious infections have occurred, or the medication regimen is not stable.
Recent use of immunosuppressive medicines – taking drugs that lower the immune system within 14 days before the first dose of durvalumab (except for low‑dose steroids, inhaled or topical steroids, or steroids used only before scans).
Allergy to durvalumab or its ingredients – known severe reaction (hypersensitivity) to the study drug or any of its components.
Investigator’s judgment – any reason the study doctor believes the patient should not take part.
Unresolved serious side effects from previous cancer treatment – lingering toxicities graded 2 or higher (except hair loss, skin color loss, or certain lab values), such as significant nerve damage, unless the doctor decides it is safe.
Cirrhosis or unstable liver/biliary disease – advanced liver scarring or liver problems causing fluid buildup, confusion, clotting issues, low protein, varices, or ongoing jaundice. Stable non‑cirrhotic liver conditions are allowed.
Severe immune‑related adverse events from prior immunotherapy – previous treatment that caused serious immune reactions such as grade 3 or higher side effects, severe nerve problems, severe skin reactions (e.g., Stevens‑Johnson syndrome), or heart inflammation (myocarditis).
Immunocompromised status – having a weakened immune system that puts the patient at high risk for infections.
Significant heart disease within the past 6 months – recent major heart problems such as heart attack, unstable angina, serious arrhythmia, or heart failure.
Concurrent cancer therapy – receiving chemotherapy, experimental drugs, biologic agents, or hormonal therapy for cancer at the same time (hormone replacement for non‑cancer reasons is allowed).

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Verified sites

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

Region Midtjylland
Responsive
Aarhus, Denmark
Region Oestergoetland
Responsive
Linkoping, Sweden
Universitetssykehuset Nord-Norge HF
Responsive
Tromsø, Norway

Trial locations

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Investigated drugs

Durvalumab is a medication given through an IV infusion that helps the body’s immune system recognize and fight cancer cells. In this trial, it is used after surgery and after patients have already received a combination of chemotherapy and immunotherapy before the operation. The goal is to see if continuing this immune‑boosting treatment can keep the lung cancer from coming back and improve the time patients stay free of disease.

Durvalumab

What is already known about the treatment

IMFINZI - This medication is given as a solution that is infused into a vein (intravenous infusion). It is an approved drug that is widely used and studied in the treatment of cancer, especially non‑small cell lung cancer. It works by attaching to a protein called PD‑L1, which helps the body’s immune system recognize and destroy cancer cells. Durvalumab belongs to the class of immune checkpoint inhibitors, a type of monoclonal antibody therapy.

Investigated diseases

Non‑small cell lung cancer - It is a common form of lung cancer that begins in the cells lining the airways. The tumor usually grows as a solid mass and expands slowly compared with small‑cell lung cancer. Over time it can invade nearby lung tissue and lymph nodes, and may later spread through the bloodstream to distant sites such as the brain, bones, or liver.