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To compare a complex induction multimodality protocol (ESPATUE) + concurrent immunotherapy with PD-L1 antibody Durvalumab given every three weeks to the same induction multimodality protocol without Durvalumab immunotherapy induction followed by definitive local treatment (surgery for those considered resectable or chemoradiation boost for those not considered to be R0-resectable) followed by consolidation Durvalumab treatment in both arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemo- and Radiochemotherapy + Durvalumab | Experimental |
| |
| Chemo- and Radiochemotherapy | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Durvalumab | Drug | Durvalumab is given earlier as registered, during chemotherapy and radiotherapy in treatment Arm A |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | Two-year progression-free survival rate | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | after 1, 2, 3, 4 and 5 years | |
| 2-y-overall survival rate | 2 years | |
| Functional response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Moell, PhD | Contact | 0049 201 72377412 | 77412 | andrea.moell@uk-essen.de |
| Name | Affiliation | Role |
|---|---|---|
| Wilfried Eberhardt, PD MD | University Hospital, Essen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum rechts der Isar - Technische Universität München | Recruiting | Munich | Bavaria | 81675 | Germany |
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to investigate functional response (PET-CT-scan) to induction therapy prior to thoracotomy |
| Week 15 |
| RECIST response (induction) | to investigate RECIST response to induction therapy in the whole Population and in both arms. | Week 9 |
| RECIST criteria | Radiological response | Through study completion, an average of every 2 months for up to 11 months |
| EORTC QLQ-C30 | Quality of life (QLQ-C30) | Through study completion, an average of every 6 weeks for up to 11 months |
| EORTC QLQ-LC13 | Quality of life (QLQ-Lung Cancer 13(LC13)) | Through study completion, an average of every 6 weeks for up to 11 months |
| FACT-L | Quality of life (Functional Assessment of Cancer Therapy-Lung (FACT-L)) | Through study completion, an average of every 6 weeks for up to 11 months |
| Universitätsklinikum Essen | Recruiting | Essen | 45147 | Germany |
| Universitätsklinikum Freiburg | Recruiting | Freiburg im Breisgau | 79106 | Germany |
| Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbH | Recruiting | Hemer | 58675 | Germany |
|
| Pius-Hospital Oldenburg | Recruiting | Oldenburg | 26121 | Germany |
| Universitätsklinikum Regensburg | Recruiting | Regensburg | 93042 | Germany |
|
| Robert-Bosch-Krankenhaus | Recruiting | Stuttgart | 70376 | Germany |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000613593 | durvalumab |
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