Condition: Stage III Non-small Cell Lung Cancer · Locally Advanced · Unresectable · Sponsor: TheraOp
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.
This description comes directly from the study's public registry record.
Bernhard Remes, Dr. · +49 641 944 36 36 · paccelio@theraop.de
Sascha Herzer · +49 641 944 36 36 · sahe@alcedis.de
Always discuss trial participation with your own doctor first.
| Universitätsklinik Carl Gustav Carus der Technischen Universität Dresden | Dresden, Germany | Recruiting |
| Universitätsklinikum Essen - Klinik für Strahlentherapie | Essen, Germany | Not Yet Recruiting |
| Medical Center - University Of Freiburg, Department of Radiation Oncology | Freiburg im Breisgau, Germany | Recruiting |
| Universitätsmedizin Göttingen, Department for Radiotherapy and Radiooncology | Göttingen, Germany | Recruiting |
| Universität des Saarlandes, Klinik für Strahlentherapie und Radioonkologie | Homburg, Germany | Recruiting |
| Kliniken Maria Hilf GmbH Mönchengladbach | Mönchengladbach, Germany | Recruiting |
| Klinikum der Universitaet Muenchen AöR, Department of Radiotherapy and Radiation Oncology | München, Germany | Recruiting |
| Pius-Hospital Oldenburg, Hematology and Oncology | Oldenburg, Germany | Recruiting |
| Vinzenz Von Paul Kliniken gGmbH, Klinik für Strahlentherapie und Palliativmedizin | Stuttgart, Germany | Recruiting |
| Überörtliche Berufsausübungsgemeinschaft Troisdorf | Troisdorf, Germany | Recruiting |
| Universitätsspital Zürich | Zurich, Switzerland | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06102057