This is an open, multi-cohort, exploratory phase II study on the safety and efficacy of TQB3616 combined with Anlotinib hydrochloride capsules or standard chemotherapy in the treatment of advanced lung cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
A CDK4/6 kinase inhibitor
A multi-target receptor tyrosine kinase inhibitor
An inhibitor of DNA topoisomerase Ⅰ
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
The Second Affiliated Hospital of PLA Air Force Military Medical University
Xi’an, Shanxi, China
Overall response rate (ORR)
Percentage of participants achieving complete response (CR) and partial response (PR).
Time frame: up to 96 weeks
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 96 weeks
Disease control rate(DCR)
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Time frame: up to 96 weeks
Duration of Response (DOR)
The time when the participants first achieved CR or PR to disease progression or death from any cause.
Time frame: up to 120 weeks
6-month progression-free survival rate
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
Time frame: up to 96 weeks
6-month and 12-month overall survival rate
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 96 weeks
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West China Hospital of Sichuan University
Chengdou, Sichuan, China
Sichuan Cancer Hospital
Chengdu, Sichuan, China
Yunnan Cancer Hospital
Kunming, Yunnan, China