Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080, China
Location status: Recruiting
NCT Number: NCT07039656
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 2
Guangzhou, Guangdong, 510080, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 24 months
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: 60 months
OS was defined as the time from the start of treatment to the date of death.
Time frame: 24 months
Incidence of AE/SAE which has been confirmed correlation with treatment.
Contact information is provided by the study sponsor or research team.
Wen-zhao ZHONG
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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