Toripalimab Combined With Chemotherapy as Adjuvant Therapy for Non-small Cell Lung Cancer With or Without Prior Neoadjuvant Therapy
Toripalimab Combined With Chemotherapy as Postoperative Adjuvant Therapy for Non-Small Cell Lung Cancer With or Without Prior Neoadjuvant Therapy: A Two-Cohort, Multicenter Phase II Trial
Wen-zhao ZHONG
211 participants
Jan 1, 2025
INTERVENTIONAL
Conditions
Summary
This is a two-cohort, multicenter, Phase II study to evaluate the efficacy and safety of 3-4 cycles of toripalimab (JS001) plus chemotherapy followed by toripalimab maintenance treatment up to one year in participants with completely resected non-small cell lung cancer (NSCLC) stratified by prior neoadjuvant treatment status, as measured by disease-free survival (DFS) and overall survival (OS). Researchers will compare outcomes between two cohorts: 1. Cohort 1: Stage IB-IIIB participants following completely resection without neoadjuvant therapy; 2. Cohort 2: Stage IIB-III participants with non-MPR or MPR but lymph node positivity after neoadjuvant therapy.
Eligibility
Plain Language Summary
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Interventions
Participants will receive Toripalimab (240 mg IV) Q3W for 17 cycles (cycle length=21 days).
Cisplatin\[75 mg/m\^2 IV Q3W\]/carboplatin\[AUC 5 IV Q3W\]+paclitaxel\[260 mg/m\^2 IV Q3W\] or cisplatin\[75 mg/m\^2 IV Q3W)\]/carboplatin\[AUC 5 IV Q3W\]+ pemetrexed\[500 mg/m2 IV Q3W\],dependent on tumor histology. Participants will receive Chemotherapy for 3-4 cycles
Locations(1)
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NCT07039656