Study of Toripalimab or Placebo Plus Chemotherapy as Treatment in Early Stage NSCLC
Status:
Recruiting
Trial end date:
2025-05-31
Target enrollment:
Participant gender:
Summary
This is a randomized, double-blind, placebo-controlled, multi-center, phase III trial to
evaluate the efficacy and safety of Toripalimab injection (JS001) combined with
platinum-based doublet chemotherapy versus placebo combined with platinum-based doublet
chemotherapy in resectable stage IIIA NSCLC.
Subjects meet all the inclusion and exclusion criteria will be paralleled assigned according
to the stratification factors as below :
- Pathological type: squamous cell carcinoma vs. non-squamous cell carcinoma
- PD-L1 status: PD-L1 expression ≥1% vs. PD-L1<1% or not evaluable
- Planned surgical operation:pneumonectomy vs. lobectomy Neoadjuvant therapy should be
started within 3 days after randomization. , Toripalimab IV 240mg Q3W will be given
combined with platinum-based doublet chemotherapy for three cycles in the neoadjuvant
setting in the experimental group; Every 3 weeks of treatment is regarded as one cycle,
in which combined therapy is given in the first day of every cycle. Placebo combined
with platinum-based doublet chemotherapy will be given for three cycles in the control
group instead..
All the subjects will receive preoperative radiological and surgical evaluation 3-5 weeks
afterneoadjuvant therapy..
,All the qualified subjects will receive radical excison based on the surgical operation
criteria of the World Association for Lung Cancer Research within 4-6 weeks after neoadjuvant
therapy. Pathologic staging based on AJCC Cancer Staging Manual (version 8) of the whole
specimens will be performed by the local pathologist. And then all the specimens will be sent
to the BIPR for further evaluation.. All the subjects accept the radical operation will
receive one cycle of postoperative neoadjuvant therapy, i.e., Toripalimab IV 240mg / placebo
+ platinum-based doublet chemotherapy, 30 days after the operation. In case of no indication
for radiotherapy, it will proceed to consolidation treatment period three weeks later; if
indicated for radiotherapy, it will proceed to consolidation treatment period 30 days after
theradiotherapy. In the consolidation treatment setting , JS001 is given byIV 240mg in each
cycle of every 3 weeks for a total of 13 cycles i in the experimental group; placebo is given
by IV 240mg in each cycle of every 3 weeks for a total of 13 cycles in the control group.
Adverse events (AE) will be monitored throughout the study, and the seriousness will be
graded tothe guideline in national cancer institute (NCI) common terminology criteria for
adverse events (CTCAE) version 5.0 or above. The safety will be followed up in the subjects
who have received treatment and discontinued the drug prematurely. All the subjects will be
followed up for overall survival, until death, withdrawal of informed consent or end of
study.