A Phase II/III Clinical Study on the Efficacy and Safety of TQB2450 Injection Combined With Chemotherapy or Anlotinib Hydrochloride Capsule in the Perioperative Treatment of Resectable Stage II/III Non Small Cell Lung Cancer.

NCT05913089 Phase 2 RECRUITING

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.

Details

Lead sponsor	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Phase	Phase 2
Status	RECRUITING
Enrolment	58
Start date	2023-06-14
Completion	2026-12

Conditions

• Non Small Cell Lung Cancer

Interventions

• TQB2450 injection + Chemotherapy
• TQB2450 injection + Anlotinib Hydrochloride Capsule

Primary outcomes

• Major pathologic response (MPR) — Baseline up to 60 months.
  MPR defined as the percentage of subjects with a residual surviving tumor less than or equal to 10% after surgery.

Countries

China