NCT04189094

Chemoradiotherapy With or Without Sintilimab in Limited-stage SCLC

Chemoradiotherapy With or Without Sintilimab in Limited-stage Small Cell Lung Cancer: a Multicenter Prospective Randomized Phase II Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is a prospective, multi-center, open-label, randomized, and controlled phase II clinical trial.

Conditions

• Small Cell Lung Cancer Limited Stage

Interventions

Type	Name	Description
DRUG	Sintilimab	Etoposide and cisplatin (carboplatin) plus Sintilimab induction therapy will be administered for 2 cycles and then thoracic radiotherapy (45 Gy/30 fractions) be administered with concurrent EP/EC chemotherapy for 2cycles. Patients who achieve CR or PR then receive prophylactic cranial irradiation (PCI, 25 Gy/10 fractions).Sintilimab maintenance therapy will be administered once every 3 week for 13 cycles.
DRUG	Etoposide	Etoposide will be administered IV 100mg/m2 on days 1-3, 22-24, 43-45 and 64-66.
DRUG	Cisplatin	cisplatin will be administered IV 80mg/m2 on days 1, 22, 43 and 64.
RADIATION	radiotherapy	Thoracic radiotherapy (45 Gy/30 fractions) and prophylactic cranial irradiation (25 Gy/10 fractions).

Timeline

• Start date: 2020-01-01
• Primary completion: 2021-07-01
• Completion: 2023-07-01
• First posted: 2019-12-06
• Last updated: 2019-12-06