A randomized, double-blind, controlled, multicenter phase III study of TQB2450 or placebo combined with Anlotinib, etoposide and carboplatin versus Etoposide and Carboplatin in subjects with extensive small cell lung cancer. The primary outcome measures include PFS and OS. Extended stage Small Cell Lung Cancer (SCLC) patients will be registered, after signing the informed consent, and then centrally randomized 1:1:1 to the experimental arms and the control arm.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
738
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
Etoposide is a cell cycle-specific antitumor drug
Carboplatin is cell cycle nonspecific antitumor drug
Subjects administrated TQB2450 (blank) intravenously (IV) on Day 1 of each 21-day
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)
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Anhui chest hospital
Hefei, Anhui, China
AnHui Provincial Hospital
Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing chest hospital,capital medical university
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China
Lanzhou University Second Hospital
Lanzhou, Gansu, China
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, China
...and 16 more locations
Progression free survival (PFS)
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
Time frame: up to 12 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 24 months
Overall response rate (ORR)
Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) .
Time frame: up to 12 months
Disease control rate (DCR)
Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD).
Time frame: up to 12 months
Duration of response(DOR)
For participants who demonstrate CR or PR, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
Time frame: up to 12 months
PFS rate of 6 and 12 months progression-free survival
PFS rate of progression-free survival at 6 and 12 months: the percentage of subjects who did not develop disease progression or die of any cause at 6 and 12 months after randomization.
Time frame: up to 12 months
OS rate of 12 and 18 months total survival
Total survival OS rate at 12 and 18 months: the proportion of subjects who died of any cause at 12 and 18 months after randomization.
Time frame: up to 12 months
Quality of life score
Time frame: up to 12 months
Incidence and severity of adverse events (AE) and serious adverse events (SAE)
Security Index
Time frame: up to 24 months
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