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Efficacy and Safety of Standard of Care Plus Durvalumab in Patients With Limited Disease Small Cell Lung Cancer (DOLPHIN)
Sponsor: Michael Hopp
Summary
Combination of concomitant Radio-Chemotherapy showed a significant improvement (Takada) of OS and PFS in limited disease SCLC patients. This clinical trial is a prospective, multicenter, randomized, open-label, parallel group phase II investigator initiated trial (ITT) to evaluate the efficacy and safety of Durvalumab in combination with Cisplatin/Etoposide/Radiotherapy in patients with limited disease small-cell lung cancer (SCLC).
Official title: A Phase II Randomized Study to Evaluate the Efficacy and Safety of Cisplatin or Carboplatin / Etoposide and Concomitant Radiotherapy Combined With Durvalumab Followed by Maintenance Therapy With Durvalumab Versus Cisplatin or Carboplatin / Etoposide and Concomitant Radiotherapy in Patients With Limited Disease Small Cell Lung Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
105
Start Date
2020-12-21
Completion Date
2026-12-31
Last Updated
2026-02-27
Healthy Volunteers
No
Conditions
Interventions
Durvalumab
Induction phase: Durvalumab (1500 mg once every 3 weeks) for 4-6 cycles in combination with standard of care (Radiochemotherapy) Maintenance phase: Durvalumab (1500 mg once every 4 weeks) until PD or unacceptable toxicities.
standard of care
Radiochemotherapy: Cisplatin (75 mg/m² (BSA) D1#) or alternatively Carboplatin (AUC 5 D1) and Etoposide (100 mg/m² (BSA) D1-3) once every 3 weeks for 4-6 cycles and concomitant Radiotherapy (60±6 Gy, 1.8-2 Gy/d or 45±1.5 Gy (1.5 Gy per fraction twice daily, with 4 hours or more between fractions) with start at latest at beginning of cycle 3, ideally during cycle 1) followed by prophylactic cranial irradiation (PCI, if clinically indicated and according to local standard at any time after completion of radio-chemotherapy)) A simultaneous administration of platinum-based chemotherapy (preferred Cisplatin) and radiotherapy for at least 2 cycles should be performed.
Locations (15)
Klinikverbund Allgäu gGmbH
Immenstadt im Allgäu, Bavaria, Germany
Asklepios Fachkliniken Muenchen Gauting
München Gauting, Bavaria, Germany
Klinikum Ernst von Bergmann
Potsdam, Brandenburg, Germany
Universitätsklinikum Gießen Marburg
Giessen, Hesse, Germany
Klinikum Kassel GmbH-Klinik für Onkologie und Hämatologie
Kassel, Hesse, Germany
Sana-Klinikum Offenbach
Offenbach, Hesse, Germany
Universitätsmedizin Rostock
Rostock, Mecklenburg-Vorpommern, Germany
Universitätsklinikum Aachen
Aachen, North Rhine-Westphalia, Germany
Lungenklinik Köln-Merheim
Cologne, North Rhine-Westphalia, Germany
KEM GmbH
Essen, North Rhine-Westphalia, Germany
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, Germany
Lungenklinik Hemer
Hemer, North Rhine-Westphalia, Germany
Johannes Wesling Klinikum Minden
Minden, North Rhine-Westphalia, Germany
Helios Kliniken Erfurt
Erfurt, Thuringia, Germany
Asklepios Klinikum Hamburg
Hamburg, Germany