Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on Durvalumab for Patients with Poor General Condition and Advanced Non-Small Cell Lung Cancer

Fast replyRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial is focused on studying Non-Small Cell Lung Cancer (NSCLC), a type of lung cancer, in patients who have a poor general health status. The treatment being tested is called Durvalumab, also known by its code name MEDI4736. Durvalumab is a type of medication known as an anti-PD-L1 monoclonal antibody, which is a protein designed to help the immune system fight cancer cells. The purpose of the study is to evaluate the safety and effectiveness of Durvalumab in patients who have not received previous treatment for their advanced stage of NSCLC and have high levels of a protein called PD-L1 in their tumors.

The study will involve patients receiving Durvalumab through an infusion, which is a method of delivering medication directly into the bloodstream. The treatment will be given over a period of up to 24 months. During the study, researchers will monitor the patients' health and any side effects they may experience. The goal is to see if Durvalumab can improve the patients' overall health and extend their survival.

This trial is particularly important because it includes patients who are often not eligible for other clinical trials due to their poor health status. By participating in this study, researchers hope to find out if Durvalumab can be a safe and effective treatment option for these patients, potentially leading to better outcomes and longer lives.

The research process

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

  1. Step 1

    Initiation of treatment

    Upon joining the study, treatment begins within 7 days. The treatment involves the administration of durvalumab, a medication used to treat non-small cell lung cancer.

    Durvalumab is given as an infusion, which means it is delivered directly into the bloodstream through a vein. The specific dosage and frequency of administration will be determined by the healthcare provider based on individual needs and response to treatment.

  2. Step 2

    Treatment monitoring

    Throughout the treatment, regular visits are scheduled to monitor the body's response to durvalumab. This includes laboratory tests and imaging studies to assess the size and progression of the tumor.

    The primary goal is to evaluate the safety and effectiveness of the treatment, ensuring that any side effects are managed promptly.

  3. Step 3

    Evaluation of treatment response

    After 8 weeks of treatment, an assessment is conducted to determine the disease control rate. This involves checking if the cancer has responded to the treatment or remained stable.

    The evaluation includes measuring the objective response rate, which indicates the percentage of patients whose cancer has shrunk or disappeared after treatment.

  4. Step 4

    Ongoing assessment

    The study continues to monitor progression-free survival (PFS) and overall survival (OS) rates. PFS refers to the length of time during and after treatment that the patient lives with the disease without it getting worse. OS measures the time from the start of treatment until death from any cause.

    Quality of life is also assessed using specific questionnaires to understand the impact of the treatment on daily living and well-being.

  5. Step 5

    Completion of trial

    The trial is expected to conclude by October 2025. At the end of the study, a comprehensive analysis of the data collected will be performed to determine the overall effectiveness and safety of durvalumab in treating non-small cell lung cancer in patients with poor general condition.

Who can join the trial?

23 criteria

  • Participants must sign a written consent form, showing they understand and agree to the study. They should be willing to attend scheduled visits and follow the treatment and testing plan.
  • Participants can have limited radiation treatment for pain relief within 2 weeks before starting the study drug, as long as the lungs are not affected and the treated area is not used to measure the tumor.
  • Participants must be between 18 and 75 years old.
  • Participants must have a tumor that can be measured using a CT scan, following specific guidelines.
  • Participants should have a life expectancy of more than 8 weeks, as judged by the study doctor.
  • Participants must have adequate biological functions, including:
    • Neutrophils (a type of white blood cell) of at least 1500 per mm3
    • Platelets (cells that help with blood clotting) of at least 75,000 per mm3
    • Hemoglobin (a protein in red blood cells) of at least 9 g/dL
    • Creatinine clearance (a measure of kidney function) greater than 40 mL/min
    • AST and ALT (liver enzymes) levels within specific limits, unless liver metastases are present
    • Serum bilirubin (a substance made by the liver) within specific limits, with exceptions for certain conditions
    • Other required tests must be completed within the specified timeframes.
    • Treatment must start within 7 days of joining the study.
    • Female participants must show evidence of being post-menopausal or have a negative pregnancy test if they are of childbearing age. Post-menopausal status is defined by specific criteria, including age and medical history.
    • Participants of childbearing potential must use effective birth control methods if sexually active, starting before the first dose and continuing for 90 days after the last dose. Certain methods like periodic abstinence are not acceptable.
    • Participants must have a confirmed diagnosis of **non-small cell lung cancer (NSCLC)**, with enough tumor material for testing.
    • The tumor must show **PD-L1 expression** in at least 25% of cells, as tested by a local lab.
    • Tumor samples must be available for further testing.
    • Participants must not have specific genetic changes, such as **EGFR mutation** or **ALK gene rearrangement**.
    • The cancer must be at **Stage IV**, which means it has spread to other parts of the body.
    • Participants must have an **ECOG performance status** of 2 or 3, indicating their ability to perform daily activities, despite receiving the best possible symptom treatment.
    • Participants must weigh more than 30 kg.
    • Participants must not have received prior systemic cancer treatment for advanced or metastatic disease, including chemotherapy, immunotherapy, or specific inhibitors. Previous treatments for earlier stages of cancer are allowed.

Who cannot join the trial?

7 criteria

  • Patients with a poor general status, meaning their overall health is not good enough to safely participate in the study.
  • Patients who do not have non-small cell lung cancer, which is a specific type of lung cancer.
  • Patients who do not have tumors that are highly PD-L1 expressing. PD-L1 is a protein that can be found on cancer cells, and high levels may affect how the cancer responds to certain treatments.
  • Patients who are not within the specified age range for the study. The study is open to certain age groups only.
  • Patients who are not part of the specified clinical trial group. This means the study is looking for participants with specific characteristics or conditions.
  • Patients who are not male or female, as the study includes both genders.
  • Patients who are not considered part of a vulnerable population. This refers to groups of people who might need special protection or consideration in research studies.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Durvalumab is a medication used in this clinical trial. It is a type of immunotherapy known as an anti-PD-L1 monoclonal antibody. Durvalumab works by helping the immune system recognize and attack cancer cells. In this trial, it is being tested for its safety and effectiveness in patients with stage IV Non-Small Cell Lung Cancer who have not received previous treatment and have high levels of PD-L1 expression. These patients typically have a poorer performance status, meaning they have more difficulty with daily activities, and are often excluded from other clinical trials. The goal is to see if Durvalumab can improve their condition and help them live longer.

What is already known about the treatment

Durvalumab – Durvalumab is administered as an intravenous infusion, typically given in a clinical setting under the supervision of healthcare professionals. It is currently being studied in clinical trials for its safety and effectiveness in treating patients with stage IV non-small cell lung cancer (NSCLC) who have high PD-L1 tumor expression and poor general health status. The main therapeutic indication for Durvalumab is as an immunotherapy for certain types of cancer, particularly NSCLC. At the molecular level, Durvalumab works by blocking the PD-L1 protein on cancer cells, which helps the immune system recognize and attack these cells. It is classified as an anti-PD-L1 monoclonal antibody, a type of immunotherapy that enhances the body's natural defenses to fight cancer.

Investigated diseases

  • Poor general status

    This condition refers to an overall decline in a person's physical health and well-being. It can manifest as fatigue, weakness, weight loss, and a reduced ability to perform daily activities. The progression of poor general status can vary depending on the underlying causes, which may include chronic diseases, malnutrition, or other health issues. Individuals with poor general status may experience a gradual worsening of symptoms, impacting their quality of life. It is often a concern in patients with serious illnesses, as it can affect their ability to tolerate treatments. Monitoring and addressing the underlying causes are crucial to managing this condition.

  • Non-small cell lung cancer

    This is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is the most common form of lung cancer, accounting for about 85% of cases. The disease typically progresses slowly compared to small cell lung cancer, but it can spread to other parts of the body if not treated. Symptoms may include a persistent cough, chest pain, shortness of breath, and unexplained weight loss. The progression of non-small cell lung cancer depends on the stage at diagnosis and other individual factors. Early detection is important for managing the disease effectively.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515943-44-00Protocol codeIFCT-1802Estimated enrolment50 patientsSponsorIntergroupe Francophone De Cancerologie Thoracique

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

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).