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ACTIVE NOT RECRUITING
NCT05092412
PHASE2

Low-dose Radiotherapy Combined With Durvalumab, Chemotherapy(EP) in the Treatment of ES-SCLC

Sponsor: You Lu

View on ClinicalTrials.gov

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.

Official title: A First-line Multi-center, Single-arm Exploratory Study Using Low-dose Radiotherapy (LDRT) Combined With Durvalumab (MEDI4736), Etoposide, and Cisplatin/Carboplatin for Patients With Extensive-stage Small Cell Lung Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2022-03-02

Completion Date

2027-06-30

Last Updated

2026-05-08

Healthy Volunteers

No

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

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.

Locations (3)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

West China Hospital Sichuan University

Chengdu, Sichuan, China