NCT06469879

A Clinical Study of TQB2450 Combined With Anlotinib in Limited-Stage Small Cell Lung Cancer Patients

A Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2450 Combined With Anlotinib as Maintenance Therapy in Patients With Limited-stage Small Cell Lung Cancer

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 358 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of TQB2450 in combination with anlotinib as maintenance therapy in patients with limited-stage small cell lung cancer who have not progressed after chemoradiotherapy.

Conditions

• Small Cell Lung Cancer Limited Stage

Interventions

Type	Name	Description
DRUG	TQB2450+Anlotinib	TQB2450 injection test group, 1200 mg/time, strength: 600mg/20 mL, intravenous drip, day 1, every 3 weeks. Anlotinib hydrochloride capsules: 8 mg/time, strength: 10mg/capsule, 8mg/capsule, 6mg/capsule., 1 time a day (QD), continuous use for 2 weeks and stop for 1 week. TQB2450 Injection Placebo (control group): 0 mg/time, strength: 0mg/20 mL, Intravenous Drip, Day 1, every 3 weeks. Anlotinib hydrochloride capsule placebo: 0 mg/time, strength: 0mg/capsule, 1 time a day (QD), continuous use for 2 weeks and stop for 1 week.
DRUG	TQB2450 placebo + Anlotinib placebo	No drug substance is contained

Timeline

• Start date: 2024-09-01
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2024-06-24
• Last updated: 2024-07-01

Locations

16 sites across 1 country: China