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Pembrolizumab and Chemotherapy Neoadjuvant/Adjuvant of NSCLC

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Primary completion date: Apr 1, 2026 to Aug 1, 2027
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 2 of 2 sites
    v4
  2. Secondary endpoints revised (4)v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 1, 2023 to Jan 30, 2024
    • Study sites: 1 to 2
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
(from sponsor)		 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
Related terms Carcinoma, Non-Small-Cell Lung
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov