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NOT YET RECRUITING
NCT06469879
PHASE3

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

Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

358

Start Date

2024-09

Completion Date

2026-09

Last Updated

2024-07-01

Healthy Volunteers

No

Interventions

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

Locations (16)

Anhui Provincial Hospital

Hefei, Anhui, China

Lanzhou University Second Hospital

Lanzhou, Gansu, China

Guangxi Medical University Cancer Hospital

Nanjing, Guangxi, China

Tangshan People's Hospital

Tangshan, Hebei, China

Harbin Medical University cancer hospital

Harbin, Heilongjiang, China

AnYang Tumor Hospital

Anyang, Henan, China

Xiangyang Central Hospital

Xiangyang, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Shandong Cancer Hospital

Jinan, Shandong, China

Shanxi Provincial Cancer Hpspital

Taiyuan, Shanxi, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

The Second People's Hospital of Neijiang

Neijiang, Sichuan, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Beijing Chest Hospital, Capital Medical University

Beijing, China