A Phase 2 interventional study of Benmelstobart in Non-Small Cell Lung Cancer, sponsored by Shanghai Pulmonary Hospital, Shanghai, China. Recruiting at 1 site in China. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2024-07-31.
Sponsored by Shanghai Pulmonary Hospital, Shanghai, China · Phase 2, Interventional, and Treatment
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.
6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.
This study's planned enrollment of 62 is close to the median of 62 across 5,327 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Shanghai Pulmonary Hospital, Shanghai, China is the lead sponsor of 157 studies on the registry; 94 are open to participants now.
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Enrolled patients will receive adjuvant immunotherapy with the PD-L1 inhibitor Benmelstobart (TQB2450) at a dose of 1200 mg every 3 weeks by intravenous injection, for a maximum of 16 cycles following radical resection.
Drug: Benmelstobart
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.
Also known as: TQB2450
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 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
Plan to share: No
Started Jun 2024 (actual). Primary completion is estimated for Jun 2027, 36 months after the start.
Of 678 non-industry phase 2 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 81. This study's planned 36 months is below that.
Counting every sponsor, half of 970 studies reached it within 48 months; a quarter within 30 and three quarters within 75.
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Studies of the drug tested here: Benmelstobart
Carcinoma, Non-Small-Cell Lung →
Shanghai Pulmonary Hospital, Shanghai, China →