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ACTIVE NOT RECRUITING
NCT04602533
PHASE2

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

Sponsor: Michael Hopp

View on ClinicalTrials.gov

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

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.

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