Clinical Trial

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

Study acronym: NEOINSPIRE
Not Yet Recruiting Phase 2
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.
Trial Details
NCT Number NCT07086326
Lead Sponsor Yang Fan, MD
Conditions NSCLC, Neoadjuvant Therapy, Immunotherapy, AK112, Bispecific Antibody
Enrollment 164 participants
Start Date 2025-07-31
Primary Completion 2026-12-30 (estimated)
Study Completion 2027-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-07-25