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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 study about?

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.

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

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)

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

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

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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Universitaet Leipzig Leipzig Germany

Other Sites

Site Name City Country Status
Muehlenkreiskliniken AöR Minden Germany
Onkologie Rheinsieg Praxisnetzwerk Troisdorf Germany
Klinikum Der Landeshauptstadt Stuttgart gKAöR Stuttgart Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Justus-Liebig-Universitaet Giessen Giessen Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Recruiting
31.12.2024

Trial locations

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.

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.

Trial ID:
2024-516367-80-00
Trial Phase:
Therapeutic exploratory (Phase II)

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