drugset / Trial / NCT05894889
Pembrolizumab and Chemotherapy Neoadjuvant/Adjuvant of NSCLC
Phase 2
Active not recruiting
70 enrolled
Peking University
Cancer Institute and Hospital, Chinese Academy of Medical Sciences · collabGuangdong Provincial People's Hospital · collabMerck Sharp & Dohme LLC · collabShanghai Pulmonary Hospital, Shanghai, China · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2024-01-30
- Primary completion
- 2027-08-01
- Completion
- 2027-08-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | — | Intravenous |
| Subject | Nab-paclitaxel | Small molecule | 135 mg/m2 | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |