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RECRUITING
NCT05377658
PHASE2

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

Sponsor: Henan Cancer Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

43

Start Date

2022-07-26

Completion Date

2027-12-31

Last Updated

2024-02-21

Healthy Volunteers

No

Interventions

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.

Locations (1)

Henan Cancer Hospital

Zhengzhou, Henan, China