NCT05377658

AK104 With Chemotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer

A Single-Arm, Phase II Study of AK104 With Chemotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

AK104, a tetravalent bispecific antibody targeting PD-1 and CTLA-4, is designed to retain the efficacy benefit of combination of PD-1 and CTLA-4 and improve on the safety profile of the combination therapy. The aim of this study is to evaluate the efficacy and safety of AK104 with chemotherapy as neoadjuvant and adjuvant therapy for patients with resectable stage II-IIIA NSCLC.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	AK104	10 mg/kg via intravenous infusion on Day 1 of each 21-day cycle.
DRUG	Albumin-Bound Paclitaxel	260mg/m\^2 via intravenous infusion on Day 1 of each 21-day cycle.
DRUG	Carboplatin	AUC 5 mg/mL/min via intravenous infusion on Day 1 of each 21-day cycle.

Timeline

• Start date: 2022-07-26
• Primary completion: 2024-12-31
• Completion: 2027-12-31
• First posted: 2022-05-17
• Last updated: 2024-02-21

Locations

1 site across 1 country: China