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NOT YET RECRUITING
NCT07086326
PHASE2

A Phase II Randomized Trial of Neoadjuvant Ivonescimab or Penpulimab Plus Chemotherapy in Resectable NSCLC

Sponsor: Yang Fan, MD

View on ClinicalTrials.gov

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

DRUG

Ivonescimab+Chemo

Ivonescimab (AK112) + platinum-based doublet chemotherapy

DRUG

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