This study is a prospective, single-arm, phase 2 clinical trial assessing the feasibility, efficacy, and safety of the PD-L1 inhibitor Benmelstobart (TQB2450) as an adjuvant therapy regimen in patients with pathologic stage IB, IASLC grade 3 invasive lung adenocarcinoma without EGFR active mutations or ALK rearrangement.
The target population for this study includes patients with pathologic stage IB, IASLC grade 3 invasive lung adenocarcinoma without EGFR active mutations or ALK rearrangement who have undergone radical resection at Shanghai Pulmonary Hospital. Patients are screened and enrolled within 4 to 12 weeks after surgery. Following surgery, adjuvant chemotherapy may be administered based on the patient's treatment needs or the attending physician's assessment. Subsequently, patients will receive adjuvant immunotherapy with the PD-L1 inhibitor Benmelstobart (TQB2450 injection) at a dose of 1200 mg every 3 weeks by intravenous injection, for a maximum of 16 cycles. The primary endpoint is the 2-year disease-free survival (DFS) rate. The secondary endpoints include the 3-year and 5-year DFS rates, the 5-year overall survival (OS) rate, and drug safety. The sample size is 62 patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
62
The PD-L1 inhibitor Benmelstobart (TQB2450) is administered as an adjuvant therapy in patients with pathologic stage IB, IASLC grade 3 invasive lung adenocarcinoma who do not have EGFR active mutations or ALK rearrangement.
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGdisease-free survival (DFS) rate
The disease-free survival (DFS) is defined as the time from surgery until disease recurrence, death from any cause, or the end of the study, whichever comes first.
Time frame: up to 2 year
disease-free survival (DFS) rate
The disease-free survival (DFS) is defined as the time from surgery until disease recurrence, death from any cause, or the end of the study, whichever comes first.
Time frame: up to 3 year
disease-free survival (DFS) rate
The disease-free survival (DFS) is defined as the time from surgery until disease recurrence, death from any cause, or the end of the study, whichever comes first.
Time frame: up to 5 year
overall survival (OS) rate
The overall survival (OS) is defined as the time from surgery to death from any cause or the end of the study, whichever comes first.
Time frame: up to 5 year
drug safety
The frequency of severe adverse events will be measured from participant enrollment to 30 days after the last drug administration or the initiation of new anti-cancer therapy, whichever comes first.
Time frame: up to 1 year
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