RecruitingPhase 2NCT06810609

Immunochemotherapy, Surgery or Chemoradiation, and Durvalumab for Stage IIIA/B NSCLC

Prospective Randomized Phase II Trial on Induction Immunochemotherapy Followed by Surgery or Definitive Chemoradiation and Consolidation Durvalumab (MEDI4736) in Resectable and Borderline Resectable Stage IIIA/B NSCLC


Sponsor

University Hospital, Bonn

Enrollment

176 participants

Start Date

Apr 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The hypothesis of the study is that induction immunochemotherapy, followed by surgery or chemoradiation and consolidation Durvalumab immunotherapy, can significantly improve event-free survival in patients with resectable or borderline resectable NSCLC at stage IIIA/B compared to existing treatment methods.


Eligibility

Min Age: 18 YearsMax Age: 74 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an intensive treatment approach for a type of esophageal or stomach cancer, combining immunotherapy, surgery or radiation, and a drug called durvalumab (an immune checkpoint inhibitor that helps the immune system fight cancer). **You may be eligible if...** - You have been diagnosed with esophageal or gastroesophageal junction cancer - Your cancer has not yet spread to distant parts of the body - You are healthy enough to tolerate surgery, chemotherapy, and immunotherapy - You meet the staging and tissue type requirements **You may NOT be eligible if...** - Your cancer has spread to distant organs (metastatic) - You have autoimmune conditions that could be worsened by immunotherapy - You have had prior treatment for this cancer - Your organ function is too impaired to handle the treatment plan Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREsurgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines

Surgical removal of the tumor in patients with resectable or borderline resectable NSCLC

RADIATIONChemoradiotherapy

Chemoradiotherapy

DRUGImmunotherapy

Immunotherapy (Durvalumab).


Locations(5)

University Hospital Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Klinikum Stuttgart

Stuttgart, Baden-Wurttemberg, Germany

University Hospital Gießen

Giessen, Hesse, Germany

Johannes Wesling Klinikum Minden Mühlenkreiskliniken, Hämatologie und Onkologie

Minden, North Rhine-Westphalia, Germany

University Hospital Bonn

Bonn, Germany

View Full Details on ClinicalTrials.gov

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NCT06810609


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