NCT06528847

Adjuvant Benmelstobart for Stage IB, Grade 3 Invasive Lung Adenocarcinoma

Benmelstobart (TQB2450) for Adjuvant Therapy in Pathologic Stage IB, IASLC Grade 3 Invasive Lung Adenocarcinomas: A Prospective, Single-arm, Phase 2 Clinical Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China · Academic / Other
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-06-05
• Primary completion: 2027-06-30
• Completion: 2030-06-30
• First posted: 2024-07-30
• Last updated: 2024-07-31

Locations

1 site across 1 country: China