Clinical Trial

Pembrolizumab and Chemotherapy Neoadjuvant/Adjuvant of NSCLC

Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
This study is to evaluate the efficacy and safety of neoadjuvant pembrolizumab plus chemotherapy following by pembrolizumab adjuvant in stage IIA-IIIB (N2) NSCLC participants without sensitizing EGFR/ALK mutation. The study will also investigate the role of CXCL13+PD1+ CD8 T cells in association with pathological response / resistance to neoadjuvant immunotherapy by comparing the proportion of CXCL13+PD1+ CD8 T cells in all CD8 T cells in post-treatment (surgical sample) between MPR group and non-MPR group.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-05-30; most recent amendment 2025-07-18.
Status change: Recruiting → Active, Not Recruiting 2025-07-18
Status change: Not Yet Recruiting → Recruiting 2024-03-31
Trial Details
NCT Number NCT05894889
Lead Sponsor Peking University
Collaborators: Merck Sharp & Dohme LLC, Shanghai Pulmonary Hospital, Shanghai, China, Guangdong Provincial People's Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions Stage IIIB(N2) Non-small Cell Lung Cancer, Stage IIA Non-small Cell Lung Cancer, Stage IIB Non-small Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer
Enrollment 70 participants
Start Date 2024-01-30
Primary Completion 2027-08-01 (estimated)
Study Completion 2027-08-01 (estimated)
Updated on ClinicalTrials.gov 2025-07-23