Durvalumab With Consolidative Radiochemotherapy and Ablative Stereotactic Radiotherapy in Oligometastatic ES-SCLC

PHASE2RecruitingINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

October 6, 2023

Primary Completion Date

March 31, 2027

Study Completion Date

December 31, 2027

Conditions
Extensive-stage Small-cell Lung Cancer
Interventions
RADIATION

Thoracic Radiochemotherapy

Radiotherapy to the primary tumor including mediastinal lymph node metastases is delivered in single fractions of 1.8Gy once daily up to a cumulative dose of 63.0Gy by intensity modulated radiation therapy (IMRT) or volumetric modulated arc therapy (VMAT).

DRUG

durvalumab

Durvalumab is administered in fixed dose 1500mg in q3w cycles concomitant to chemotherapy and q4w cycles during maintenance treatment

RADIATION

Stereotactic radiotherapy of further tumor locations

Stereotactic radiotherapy is delivered to the up to four further tumor locations during durvalumab maintenance therapy and will be performed according to local standards with established dose and fractionation schemes in ablative doses depending on the affected organ system.

DRUG

Chemotherapy

Concomitant chemotherapy consists of further two cycles platinum/etoposide q3w (summarized cycle 3-4).

Trial Locations (5)

41063

RECRUITING

Kliniken Maria Hilf, Mönchengladbach

66421

RECRUITING

Saarland University Medical Center and Saarland University Faculty of Medicine, Clinic for Radiotherapy and Radiooncology, Homburg

86156

RECRUITING

University Hospital Augsburg, Radiation Oncology, Augsburg

91054

RECRUITING

University Hospital Erlangen, Radiation Oncology, Erlangen

93053

RECRUITING

University Hospital Regensburg, Clinic and Polyclinic for Radiotherapy, Regensburg

All Listed Sponsors
lead

Universität des Saarlandes

OTHER