Low-dose Radiotherapy Combined With Durvalumab, Chemotherapy(EP) in the Treatment of ES-SCLC
NCT05092412 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-05-08
Summary
The purpose of this study was to evaluate the efficacy of low-dose radiotherapy (LDRT) combined with durvalumab, etoposide, and cisplatin/carboplatin in the first-line treatment of extensive-stage small cell lung cancer.
Conditions
- Lung Cancer
- Extensive-stage Small-cell Lung Cancer
- Durvalumab
Interventions
- RADIATION
-
Low-dose radiotherapy
The LDRT deals with primary tumour in a 15 Gy of 5fractions over five days, starting from Day 1 in the first cycle.
- DRUG
-
Durvalumab 1500 mg intravenous infusion, started to be used simultaneously with chemotherapy at week 0 and continued after chemotherapy.
- DRUG
-
Etoposide, and cisplatin/carboplatin
Starting from week 0, the dose of etoposide + carboplatin or cisplatin in the study will not exceed the dose for specific indications in the product instructions (etoposide \[80 to 100mg/m2\] via intravenous infusion and carboplatin \[ The area under the curve (AUC) is 5-6\] by intravenous infusion or cisplatin \[75-80 mg/m2\] by intravenous infusion), using up to 4 cycles. The choice of platinum drugs is at the discretion of the investigator.
Sponsors & Collaborators
- collaborator INDUSTRY
-
You Lu
lead OTHER
Principal Investigators
-
You Lu, MD · West China Hospital
-
Yan Zhang, MD · West China Hospital
-
Yue Xie, MM · Chongqing University Cancer Hospital
-
Shu Jie Li, MM · Chongqing University Cancer Hospital
-
Shun Dong Cang, MD · Henan Provincial People's Hospital
-
Lu Lu Su, MD · Henan Provincial People's Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-03-02
- Primary Completion
- 2023-02-06
- Completion
- 2027-06-30
Countries
- China
Study Locations
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