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A Study of Toripalimab or Placebo Plus Chemotherapy as Treatment in Early Stage NSCLC

2019-11-14 17:39:46 | BioPortfolio

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 after neoadjuvant therapy.

All the qualified subjects will receive radical excision 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 the radiotherapy. In the consolidation treatment setting, JS001 is given by IV 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 to the 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.

Study Design

Conditions

Stage IIIA Non-small Cell Lung Cancer

Intervention

Toripalimab + platinum-based doublet chemotherapy, Placebo + platinum-based doublet chemotherapy

Status

Not yet recruiting

Source

Shanghai Junshi Bioscience Co., Ltd.

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-11-14T17:39:46-0500

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Medical and Biotech [MESH] Definitions

Platinum. A heavy, soft, whitish metal, resembling tin, atomic number 78, atomic weight 195.09, symbol Pt. (From Dorland, 28th ed) It is used in manufacturing equipment for laboratory and industrial use. It occurs as a black powder (platinum black) and as a spongy substance (spongy platinum) and may have been known in Pliny's time as "alutiae".

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Organic compounds which contain platinum as an integral part of the molecule.

Rhodium. A hard and rare metal of the platinum group, atomic number 45, atomic weight 102.905, symbol Rh. (Dorland, 28th ed)

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