RecruitingPhase 2NCT06102057

PACCELIO - FDG-PET Based Small Volume Accelerated Immuno Chemoradiotherapy in Locally Advanced NSCLC


Sponsor

TheraOp

Enrollment

110 participants

Start Date

Jul 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Multinational, randomized, controlled, open-label, multicenter phase II trial. Eligible patients will be randomized in a ratio of 1:1 to Experimental Arm (FDG-PET-based small volume accelerated radiotherapy with concurrent standard of care chemotherapy) or Conventional Arm (standard FDG-PET-based radiotherapy with concurrent standard of care chemotherapy). Patients showing complete response, partial response, or stable disease following chemoradiotherapy will receive standard of care consolidation therapy with durvalumab (fixed dose of 1500 mg q4w) for up to 12 months or until progression of disease, unacceptable toxicity, patient´s wish, or investigator´s decision, whichever comes first. After end of durvalumab therapy, patients will undergo safety follow up for 90 (+7) days followed by survival follow up until overall end of study. Overall end of study will be reached 24 months after the last patient has started durvalumab therapy. Patients showing PD following chemoradiotherapy will be treated according to investigator´s decision but will be followed up until overall end of study.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study — called PACCELIO — is testing whether a specialized PET scan (FDG-PET) can be used to guide smaller, more targeted radiation treatment fields combined with immunotherapy and chemotherapy for people with locally advanced, inoperable non-small cell lung cancer (NSCLC). The goal is to reduce radiation side effects while maintaining effectiveness. **You may be eligible if...** - You are 18 years or older - You have been confirmed to have inoperable, locally advanced (Stage III) non-small cell lung cancer (NSCLC) - Your tumor has at least 1% PD-L1 expression (a marker that helps predict response to immunotherapy) - You are in good general health (ECOG 0–1) - You are fit to receive combined chemotherapy, radiation, and immunotherapy - A recent FDG-PET scan has been done within 21 days before starting treatment - Your lung function tests are within acceptable range **You may NOT be eligible if...** - You have already received systemic treatment for this lung cancer - You have serious autoimmune conditions - You have significant other illnesses that make combination treatment unsafe - Your lung function is too low to tolerate treatment 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

RADIATIONstandard Radiotherapy

standard FDG-PET-based radiotherapy

DRUGChemotherapy

concurrent standard of care chemotherapy

DRUGImmunotherapy

standard of care consolidation therapy with durvalumab (fixed dose of 1500 mg q4w) for up to 12 months or until progression of disease, unacceptable toxicity, patient´s wish, or investigator´s decision, whichever comes first.

RADIATIONExperimental Radiotherapy

FDG-PET-based small volume accelerated radiotherapy


Locations(11)

Universitätsklinik Carl Gustav Carus der Technischen Universität Dresden

Dresden, Germany

Universitätsklinikum Essen - Klinik für Strahlentherapie

Essen, Germany

Medical Center - University Of Freiburg, Department of Radiation Oncology

Freiburg im Breisgau, Germany

Universitätsmedizin Göttingen, Department for Radiotherapy and Radiooncology

Göttingen, Germany

Universität des Saarlandes, Klinik für Strahlentherapie und Radioonkologie

Homburg, Germany

Kliniken Maria Hilf GmbH Mönchengladbach

Mönchengladbach, Germany

Klinikum der Universitaet Muenchen AöR, Department of Radiotherapy and Radiation Oncology

München, Germany

Pius-Hospital Oldenburg, Hematology and Oncology

Oldenburg, Germany

Vinzenz Von Paul Kliniken gGmbH, Klinik für Strahlentherapie und Palliativmedizin

Stuttgart, Germany

Überörtliche Berufsausübungsgemeinschaft Troisdorf

Troisdorf, Germany

Universitätsspital Zürich

Zurich, Switzerland

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NCT06102057


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