NCT07086326

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

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)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 164 (estimated)
• Sponsor: Yang Fan, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• NSCLC
• Neoadjuvant Therapy
• Immunotherapy
• AK112
• Bispecific Antibody

Interventions

Type	Name	Description
DRUG	Ivonescimab+Chemo	Ivonescimab (AK112) + platinum-based doublet chemotherapy
DRUG	Penpulimab+Chemo	Penpulimab (AK105) + platinum-based doublet chemotherapy

Timeline

• Start date: 2025-07-31
• Primary completion: 2026-12-30
• Completion: 2027-12-30
• First posted: 2025-07-25
• Last updated: 2025-07-25

Locations

5 sites across 1 country: China