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A Phase II Randomized Trial of Neoadjuvant Ivonescimab or Penpulimab Plus Chemotherapy in Resectable NSCLC
Sponsor: Yang Fan, MD
Summary
This is a randomized, open-label, multicenter phase II study. The trial plans to enroll 164 subjects with resectable stage IIA-IIIB (N2) NSCLC. Participants will be randomized 1:1 into either the ivonescimab plus chemotherapy or penpulimab plus chemotherapy treatment arm. After 3-4 cycles of neoadjuvant therapy, surgical resection will be performed. The primary objective is to compare the pathological complete response (pCR) rate assessed by local pathologists between ivonescimab-based and penpulimab-based chemo-immunotherapy regimens in the neoadjuvant treatment of resectable NSCLC.
Official title: A Prospective, Randomized, Open-label, Controlled Phase Ⅱ Clinical Trial of Ivonescimab Combined With Chemotherapy Versus Penpulimab Combined With Chemotherapy for Neoadjuvant Treatment of Non-small Cell Lung Cancer (NSCLC)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
164
Start Date
2025-07-31
Completion Date
2027-12-30
Last Updated
2025-07-25
Healthy Volunteers
No
Interventions
Ivonescimab+Chemo
Ivonescimab (AK112) + platinum-based doublet chemotherapy
Penpulimab+Chemo
Penpulimab (AK105) + platinum-based doublet chemotherapy
Locations (5)
Peking University People's Hospital
Beijing, Beijing Municipality, China
Hunan Cancer Hospital
Changsha, Hunan, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China