A Phase 2 interventional study of Toripalimab and Cisplatin-based chemotherapy in Stage IB-IIIB NSCLC and Stage IIB-III NSCLC, sponsored by Wen-zhao ZHONG. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-08-07.
Sponsored by Wen-zhao ZHONG · Phase 2, Interventional, and Treatment
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:
Wen-zhao ZHONG is the lead sponsor of 9 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Toripalimab · Drug: Cisplatin-based chemotherapy
Drug: Toripalimab · Drug: Cisplatin-based chemotherapy
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
2-year Disease-Free Survival
DFS was defined as the time from the start of the treatment to either the date of disease recurrence or death (whatever the cause) as assessed by the investigator. Recurrence of disease was defined as local regional recurrence, a distant (metastatic) recurrence, or a second primary cancer. Occurrence of a second extra-pulmonary malignancy was considered to be an event.
Time frame: 24 months
Overall Survival
OS was defined as the time from the start of treatment to the date of death.
Time frame: 60 months
Adverse events
Incidence of AE/SAE which has been confirmed correlation with treatment.
Time frame: 24 months
Plan to share: No — Treatment and survival data for participants will be presented in the corresponding manuscript.
No publications or documents are linked to this record.
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Wen-zhao ZHONG