This study is a randomized, double-blind, double-dummy,placebo parallel controlled, multi-centre,phase III clinical trial to evaluate the efficacy and safety of TQB2450 with or without anlotinib compared with placebo as consolidation treatment in subjects with locally advanced/unresectable (Stage III) Non-Small Cell Lung Cancer that has not progressed after prior concurrent/sequential chemoradiotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
315
TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.
a multi-target receptor tyrosine kinase inhibitor
Subjects administrated TQB2450 (blank) intravenously (IV) on Day 1 of each 21-day
Progression Free Survival (PFS) evaluated by Independent Review Committee(IRC)
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause, based on IRC.
Time frame: up to 33 months
PFS evaluated by Investigator
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause, based on investigator.
Time frame: up to 33 months
Overall survival (OS)
OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
Time frame: up to 5 years
Overall response rate (ORR)
Percentage of participants achieving complete response (CR) and partial response (PR).
Time frame: up to 33 months
Disease control rate(DCR)
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Time frame: up to 33 months
Duration of response(DOR)
The time when the participants first achieved complete or partial remission to disease progression.
Time frame: up to 33 months
PFS rate at month 6
The percentage of PFS at month 6
Time frame: up to 6 months
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Subjects administrated anlotinib (blank) in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)
Anhui Chest Hospital
Hefei, Anhui, China
NOT_YET_RECRUITINGPeking Union Medical College Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGChongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
RECRUITINGThe First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGFujian Cancer Hospital
Fuzhou, Fujian, China
NOT_YET_RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGThe First Affiliated Hospital Sun Yat-Sen University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGYuebei People's Hospital
Shaoguan, Guangdong, China
NOT_YET_RECRUITINGAffiliated Hospital of Guangdong Medical University
Zhangjiang, Guangdong, China
NOT_YET_RECRUITINGThe Fifth Affiliated Hospital Sun Yat-Sen University
Zhuhai, Guangdong, China
RECRUITING...and 26 more locations
PFS rate at month 12
The percentage of PFS at month 12
Time frame: up to 12 months
Biomarkers, such as PD-L1 expression, etc.
Tissue samples were collected during the screening period for pd-l1 analysis. Blood samples were collected for Tumor Mutation Burden (TMB) test before enrollment (within 7 days before medication) and after exit (±3 days).
Time frame: up to 33 months
Immunogenicity, such as the incidence of ADA
Degree of the immune response caused by the drug.
Time frame: on day 1, 42, 105, 189 and 90 days after the last administration.