drugset / Trial / NCT07086326

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

NCT07086326

Phase 2 Not yet recruiting 164 enrolled Yang Fan, MD
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-07-31
Primary completion
2026-12-30
Completion
2027-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Ivonescimab Monoclonal antibody
Comparator Penpulimab Monoclonal antibody