NCT04562337

SHR-1316 Combined With Chemotherapy and Chest Radiotherapy in ES-SCLC

SHR-1316 Plus Chemotherapy and Sequential Thoracic Radiotherapy as First-line Therapy for Extensive-stage Small-Cell Lung Cancer (ES-SCLC): a Phase II Trial

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Shandong Cancer Hospital and Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a one arm, open, single center phase II study. The main purpose of this study was to evaluate the tolerance and preliminary efficacy of SHR1316 combined with chest radiotherapy after induction therapy.

Detailed description

This is a single-arm, single-center phase II study. Eligible subjects will receive the following treatment regimens: 4\~6 cycles of SHR1316 combined with EP/EC (etoposide, 100mg/m2, D1-3, q3w and cisplatin, 75mg/m², D1, q3w or carboplatin, AUC=5, D1, q3w). Patients with response sequentially received adebrelimab combined with chest radiotherapy based on investigator decision. Patients then the maintenance therapy with adebrelimab until disease progression or intolerable AEs.

Conditions

• Extensive-stage Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	SHR1316	Anti-PD-L1 antibody
DRUG	Carboplatin	Carboplatin intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).
DRUG	Etoposide	Etoposide intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).
RADIATION	Radiation therapy	Thoracic radiation therapy ,TRT
DRUG	Cisplatin	Cisplatin intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).

Timeline

• Start date: 2020-10-01
• Primary completion: 2024-10-01
• Completion: 2024-10-01
• First posted: 2020-09-24
• Last updated: 2024-07-03

Locations

1 site across 1 country: China