This is a clinical study on the efficacy and safety of TQB2450 injection combined with chemotherapy or anlotinib hydrochloride capsule in the perioperative treatment of resectable non-small cell lung cancer. The part I study was planned to enroll 58 subjects, 1:1 randomized into two cohorts. The treatment regimen was as follows: Cohort 1: 3-4 cycles of TQB2450 combined with chemotherapy, surgery should be performed 4-6 weeks after the last administration, and TQB2450 therapy should be continued for 1 year after surgery. Cohort 2: 4 cycles of TQB2450 combined with 3 cycles of anlotinib hydrochloride capsule. Surgery was performed 4-6 weeks after the last dose and continued for 1 year starting 4 weeks after surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
TQB2450 injection is a humanized monoclonal antibody targeting programmed death ligand -1 (PD-L1). Chemotherapy is a systematic treatment that kill fast growing cells.
TQB2450 injection is a humanized monoclonal antibody targeting programmed death ligand -1 (PD-L1). Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor.
Cancer Hospital of Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGBeijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGBeijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGBeijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGFujian Medical University Union Hospital
Fuzhou, Fujian, China
RECRUITINGWeifang People's Hospital
Weifang, Shandong, China
RECRUITINGShanghai Chest Hospital
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGShanxi Cancer Hospital
Taiyuan, Shanxi, China
RECRUITINGTianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
NOT_YET_RECRUITINGTianjin Chest Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGMajor pathologic response (MPR)
MPR defined as the percentage of subjects with a residual surviving tumor less than or equal to 10% after surgery.
Time frame: Baseline up to 60 months.
Overall survival (OS)
From randomization to the time of death from any cause.
Time frame: Baseline up to 60 months.
2/3 year OS rate
The ratio of two-year survival to three-year survival.
Time frame: Baseline up to 36 months.
Event free survival (EFS) assessed by the investigator.
From the time of randomization to the occurrence of a predetermined event, including death, disease progression, change to chemotherapy, change to chemotherapy, addition of other treatments, occurrence of fatal or intolerable side effects, etc.
Time frame: Baseline up to 60 months.
Disease free survival (DFS) assessed by Blinded Independent Central Review (BICR)
The time from randomization to the onset of tumor recurrence or death from any cause.
Time frame: Baseline up to 60 months.
Pathological complete response (pCR)
Ratio of patients with no residual cancer cells found in the pathological examination after treatment.
Time frame: Baseline up to 4 months.
R0 resection rate
The proportion of subjects who could undergo R0 resection, which is one of the surgery-related end points.
Time frame: Baseline up to 4 months.
Surgical delay rate
The proportion of subjects who could not undergo surgery in time after neoadjuvant therapy.
Time frame: Baseline up to 4 months.
Pathological downgrading rate
The proportion of patients with reduced lung cancer stage determined by pathological results after surgery.
Time frame: Baseline up to 4 months.
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