Efficacy and Safety of Standard of Care Plus Durvalumab in Patients With Limited Disease Small Cell Lung Cancer (DOLPHIN)

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

105

Participants

Timeline

Start Date

December 21, 2020

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Small Cell Lung Cancer Limited Stage
Interventions
DRUG

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.

DRUG

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."

Trial Locations (16)

14467

Klinikum Ernst von Bergmann, Potsdam

18059

Universitätsmedizin Rostock, Rostock

21075

Asklepios Klinikum Hamburg, Hamburg

32429

Johannes Wesling Klinikum Minden, Minden

34125

Klinikum Kassel GmbH-Klinik für Onkologie und Hämatologie, Kassel

35392

Universitätsklinikum Gießen Marburg, Giessen

45136

KEM GmbH, Essen

45147

Universitätsklinikum Essen, Essen

51109

Lungenklinik Köln-Merheim, Cologne

52074

Universitätsklinikum Aachen, Aachen

58675

Lungenklinik Hemer, Hemer

63069

Sana-Klinikum Offenbach, Offenbach

74245

Klinik Löwenstein gGmbH, Löwenstein

82131

Asklepios Fachkliniken Muenchen Gauting, München Gauting

87509

Klinikverbund Allgäu gGmbH, Immenstadt im Allgäu

99089

Helios Kliniken Erfurt, Erfurt

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

lead

Michael Hopp

OTHER