Recruiting

Study of Durvalumab with chemotherapy (paclitaxel, cisplatin, carboplatin, vinorelbine) in patients with stage IIIA/B non-small cell lung cancer that can be removed by surgery

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What is this trial about?

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

This clinical trial studies the treatment of Non-Small Cell Lung Cancer (NSCLC) that has spread to nearby tissues or lymph nodes but may still be removable by surgery (stage IIIA/B). The study tests a combination treatment approach using several medications: durvalumab (an immunotherapy drug that helps the immune system fight cancer cells), along with standard chemotherapy drugs including paclitaxel, cisplatin, carboplatin, and vinorelbine.

The purpose of this research is to determine how effective a combined treatment approach is for patients with this type of lung cancer. The treatment plan includes initial therapy with immunotherapy and chemotherapy, followed by either surgery or a combination of chemotherapy and radiation therapy. After these treatments, patients receive additional immunotherapy for up to 12 months.

During the study, patients will receive medications through infusion, which means the drugs are given directly into a vein. Doctors will monitor how well the treatment works and track any side effects that may occur. The study will measure how long patients live without their cancer getting worse or returning after treatment begins.

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
Initial treatment phase
You will receive induction immunochemotherapy treatment which combines immune therapy and chemotherapy
The treatment includes durvalumab (immune therapy) given through infusion
You will also receive chemotherapy drugs (paclitaxel and cisplatin) through infusion
Step 2
Treatment path decision
Based on your response to the initial treatment, your case will be assigned to one of two treatment paths:
Path A: Surgery to remove the tumor
Path B: Chemotherapy combined with radiation therapy (chemoradiation)
Step 3
Continuation therapy
After either surgery or chemoradiation, you will receive consolidation therapy with durvalumab
This continuation treatment lasts for 12 months
The medication will be given through infusion
Step 4
Follow-up period
Your health status will be monitored for 2 years after starting the treatment
Regular medical examinations will check for any signs of disease progression
Quality of life assessments will be conducted throughout this period
Step 5
Additional monitoring
Regular blood tests will check your organ function and blood cell counts
Imaging scans will be performed to monitor your response to treatment
Side effects will be tracked and documented throughout the entire treatment period

Who can join the trial?

18 criteria

Age between 18 and 75 years
Both men and women can participate
Must be able to provide written informed consent
Cancer must be suitable for complete surgical removal
Must have sufficient physical health to undergo surgery
Life expectancy greater than 12 weeks
Body weight above 30 kg
Must have normal organ and bone marrow function, including:
- Blood hemoglobin level ≥ 9.0 g/dL
- White blood cell count within specified limits
- Platelet count within normal range
- Liver and kidney function within normal limits
- Stable heart function (no heart attack in past 6 months)
- Must have ECOG performance status of 0 or 1 (able to perform daily activities with minimal assistance)
- Must have confirmed NSCLC (Non-Small Cell Lung Cancer) that is negative for certain genetic mutations (EGFR and ALK)
- Must be willing to follow all study requirements, including regular visits and examinations
- If able to have children, must agree to use effective contraception during the study and for specified time afterward
- Women who can become pregnant must take monthly pregnancy tests
- Post-menopausal women or women with negative pregnancy test can participate

Who cannot join the trial?

15 criteria

Age below 18 years or above 75 years
Previous treatments with immunotherapy (treatments that help your immune system fight cancer)
Previous chemotherapy or radiation therapy for lung cancer
Presence of cancer that has spread to other parts of the body (metastatic disease)
Serious heart conditions or uncontrolled heart disease
Active or untreated infections
History of other cancers within the last 5 years (except for successfully treated non-melanoma skin cancer or cervical cancer in situ)
Autoimmune diseases (conditions where your immune system attacks your own body)
Pregnancy or breastfeeding
Known allergies to study medications
Serious lung diseases other than cancer that significantly affect breathing
Untreated brain or spinal cord involvement
Active hepatitis B or C, or HIV infection
Mental conditions that could interfere with following study procedures
Use of medications that suppress the immune system

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Verified sites

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

Justus-Liebig-Universitaet Giessen
Verified
Giessen, Germany
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Responsive
Stuttgart, Germany
Medical Center - University Of Freiburg
Verified
Freiburg Im Breisgau, Germany

Trial locations

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Investigated drugs

Durvalumab
(also known as MEDI4736) is an immunotherapy medication that helps your immune system fight cancer cells. It works by blocking a protein that cancer cells use to hide from your immune system. This medication is given after other treatments to help prevent cancer from returning.
Chemotherapy
refers to standard cancer-fighting medications given in combination to kill cancer cells. In this trial, it's used as part of the initial treatment before surgery or radiation.
Chemoradiation
is a combined treatment that uses both chemotherapy medications and radiation therapy together. This approach targets cancer cells using both methods simultaneously to make the treatment more effective.
Immunochemotherapy
combines standard chemotherapy with immunotherapy medications. This combination helps both directly kill cancer cells and boost your body's natural ability to fight cancer.

What is already known about the treatment

Durvalumab – A monoclonal antibody medication administered through intravenous infusion that belongs to the class of immune checkpoint inhibitors. This drug works by binding to PD-L1 (programmed death-ligand 1) on tumor cells, preventing them from evading the immune system's response, thus helping the body's immune cells to detect and attack cancer cells. It is primarily used in the treatment of non-small cell lung cancer (NSCLC), particularly in stage III cases where the cancer is resectable or borderline resectable. Durvalumab is typically used as part of a multimodal treatment approach, often in combination with chemotherapy and/or radiation therapy, and can be administered as consolidation therapy for up to 12 months.

Investigated diseases

Non-small Cell Lung Cancer (NSCLC) – A type of lung cancer that begins in the epithelial cells of the lung tissue. It typically grows and spreads more slowly than small cell lung cancer. Stage IIIA/B indicates that the cancer has spread to lymph nodes in the chest, particularly those around the trachea, bronchi, or mediastinum. The disease can affect different parts of the lung tissue and can spread to nearby structures in the chest. NSCLC may develop gradually, often starting in the lining of the bronchi or other parts of the lung. The condition can progress from being localized in the lung to involving nearby lymph nodes.