Clinical Trial: NCT04351256
Thoracic Radiotherapy Plus Durvalumab in Elderly and/or Frail NSCLC Stage III Patients Unfit for Chemotherapy
Status:
COMPLETEDPhase:
Phase 2| Lead Sponsor: | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest |
| Information Provided By: | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest |
| Last Update Posted: | 2026-03-27 |
Study Overview
Brief Summary
This is a randomized, open-label, multicenter, phase II trial investigating the combination of thoracic radiotherapy plus Durvalumab in patients with locally advanced, unresectable NSCLC (stage III) that are unfit for chemotherapy (e.g. due to age and/or frailty).
Official Title
Thoracic Radiotherapy Plus Durvalumab in Elderly and/or Frail NSCLC Stage III Patients Unfit for Chemotherapy - Employing Optimized (Hypofractionated) Radiotherapy to Foster Durvalumab Efficacy
Conditions
NSCLC, Stage III
Intervention / Treatment
- Drug: Durvalumab Injection [Imfinzi]
- Radiation: Thoracic Radiotherapy (TRT) conventionally
- Radiation: Thoracic Radiotherapy (TRT) hypofractionated
Other Study ID Numbers
- TRADE-hypo
- 2019-002192-33
- AIO-YMO/TRK-0319
- ESR-18-13893
- 2024-513948-28-00
- 2019
Start Date (Actual)
2020-05-20
Primary Completion Date (Actual)
2026-01-21
Study Completion Date (Actual)
2026-01-21
Enrollment (Actual)
51
Study Type
Interventional
Phase
Phase 2
| Lead Sponsor: | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest |
| Information Provided By: | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest |
| Last Update Posted: | 2026-03-27 |
Study Overview
Brief Summary
This is a randomized, open-label, multicenter, phase II trial investigating the combination of thoracic radiotherapy plus Durvalumab in patients with locally advanced, unresectable NSCLC (stage III) that are unfit for chemotherapy (e.g. due to age and/or frailty).
Official Title
Thoracic Radiotherapy Plus Durvalumab in Elderly and/or Frail NSCLC Stage III Patients Unfit for Chemotherapy - Employing Optimized (Hypofractionated) Radiotherapy to Foster Durvalumab Efficacy
Conditions
NSCLC, Stage III
Intervention / Treatment
- Drug: Durvalumab Injection [Imfinzi]
- Radiation: Thoracic Radiotherapy (TRT) conventionally
- Radiation: Thoracic Radiotherapy (TRT) hypofractionated
Other Study ID Numbers
- TRADE-hypo
- 2019-002192-33
- AIO-YMO/TRK-0319
- ESR-18-13893
- 2024-513948-28-00
- 2019
Start Date (Actual)
2020-05-20
Primary Completion Date (Actual)
2026-01-21
Study Completion Date (Actual)
2026-01-21
Enrollment (Actual)
51
Study Type
Interventional
Phase
Phase 2