1. Progression-free survival (PFS) (Time Frame - 18 months): Progression-free survival (PFS) after 18 months according to iRECIST
Secondary outcome:
1. Progression-free survival (PSF) after other assessments (Time Frame - 12 months): Time between first application of trial medication to date of disease progression or death due to any cause
2. Overall survival (OS) (Time Frame - 18 months): Time between first application of trial medication to date of death due to any cause
3. Overall response rate (ORR) (Time Frame - 18 months): Complete Response or Partial Response according to iRECIST
4. Disease control rate (DCR) (Time Frame - 18 months): Complete Response, Partial Response or Stable Disease according to iRECIST
5. Quality of Life Questionnaire - Cancer 30 (QLQ-C30) (Time Frame - 18 months): Symptom control assessed by patient-reported quality of life (QoL) with QLQ-C30. The score ranges from 0 to 100. The higher the score the better the outcome.
6. Quality of Life Questionnaire - Lung Cancer 13 (QLQ-LC13) (Time Frame - 18 months): Symptom control assessed by patient-reported quality of life (QoL) with QLQ-LC13. The scores ranges from 0 to 100. The higher the score the better the outcome.
7. EuroQol five dimension scale (EQ-5D) (Time Frame - 18 months): Symptom control assessed by patient-reported quality of life (QoL) with EQ-5D. The score consists of 5 items on a three step scale and a VAS scale ranging from 0 to 100. The lower the score on the three step scales the better the outcome and the higher the score on the VAS scale the better the outcome.
Experimental: 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.
Other: standard of care Induction phase: Radiochemotherapy according to guideline
Maintenance: Standard of care
Durvalumab (IMFINZI®): 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.
Quelle: ClinicalTrials.gov
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"Efficacy and Safety of Standard of Care Plus Durvalumab in Patients With Limited Disease Small Cell Lung Cancer (DOLPHIN)"
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