A Clinical Study of TQB2450 Combined With Anlotinib in Limited-Stage Small Cell Lung Cancer Patients
NCT Number: NCT06469879
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Small Cell Lung Cancer Limited Stage
Interventions: DRUG: TQB2450+Anlotinib|DRUG: TQB2450 placebo + Anlotinib placebo
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 358
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-09
Locations: Anhui Provincial Hospital, Hefei, Anhui, 23002, China|Lanzhou University Second Hospital, Lanzhou, Gansu, 730030, China|Guangxi Medical University Cancer Hospital, Nanjing, Guangxi, 530021, China|Tangshan People's Hospital, Tangshan, Hebei, 63001, China|Harbin Medical University cancer hospital, Harbin, Heilongjiang, 150081, China|AnYang Tumor Hospital, Anyang, Henan, 455001, China|Xiangyang Central Hospital, Xiangyang, Hubei, 441021, China|Hunan Cancer Hospital, Changsha, Hunan, 410013, China|The First Hospital of China Medical University, Shenyang, Liaoning, 110002, China|Qilu Hospital of Shandong University, Jinan, Shandong, 250063, China|Shandong Cancer Hospital, Jinan, Shandong, 250117, China|Shanxi Provincial Cancer Hpspital, Taiyuan, Shanxi, 030000, China|The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shanxi, 710061, China|The Second People's Hospital of Neijiang, Neijiang, Sichuan, 641199, China|Zhejiang Cancer Hospital, Hangzhou, Zhejiang, 310022, China|Beijing Chest Hospital, Capital Medical University, Beijing, 101149, China

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.

Primary Outcome Measures: Progression-free survival (PFS) evaluated by the Independent Review Committee (IRC), Random to the time of disease progression or death., up to 33 months
Secondary Outcome Measures: Progression-free survival (PFS) evaluated by researcher, Random to the time of disease progression or death., up to 33 months|Overall survival (OS), Time from random to death., About 5 years|Objective mitigation rate (ORR), The proportion of patients whose tumor volume shrinks to the predetermined value and can maintain the minimum time limit is the sum of the proportion of complete remission (CR) and partial remission (PR)., up to 33 months|Remission duration (DOR), The period when the first judgment is complete or partial remission until it is found to be the progress of the disease., up to 33 months|Disease control rate, The number of cases with remission (PR+CR) and disease stability (SD) after treatment as a percentage of the number of evaluable cases., up to 33 months|No progress survival PFS rate in 12 or 24 months, If the tumor progresses or dies in 12 or 24 months, the time is from the beginning of the follow-up to the event. The proportion of all subjects who have not yet occurred at a certain time is called (no progress) survival rate., up to 33 months