AK104 With Chemotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer
NCT05377658 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43
Last updated 2024-02-21
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
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
-
AUC 5 mg/mL/min via intravenous infusion on Day 1 of each 21-day cycle.
Sponsors & Collaborators
-
Henan Cancer Hospital
lead OTHER_GOV
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-07-26
- Primary Completion
- 2024-12-31
- Completion
- 2027-12-31
Countries
- China
Study Locations
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