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

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


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


Stage IIIA Non-small Cell Lung Cancer


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


Not yet recruiting


Shanghai Junshi Bioscience Co., Ltd.

Results (where available)

View Results


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

Clinical Trials [4037 Associated Clinical Trials listed on BioPortfolio]

REGN2810 (Anti-PD-1 Antibody), Ipilimumab (Anti-CTLA-4 Antibody), and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer

The primary objective is to compare the progression-free survival (PFS) of REGN2810 plus platinum-based doublet chemotherapy combination therapy (REGN2810/chemo) and REGN2810 plus platinum...

Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects

This is a phase III study of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab in previously untreated locally advanced or metastatic non-squamous and squa...

RRx-001 Prior to a Platinum Doublet or a Platinum Doublet Alone in Patients With Small Cell Carcinoma

The purpose of this study is to find out more about the experimental drug called RRx-001, which is a form of immunotherapy called a checkpoint inhibitor, that is also thought to reduce res...

Study of KN046 With Chemotherapy in First Line Advanced NSCLC

This is a phase II study of KN046 plus platinum-based doublet chemotherapy in previously untreated advanced non-squamous and squamous NSCLC subjects. The study will assess primarily the s...

AVE8062 in Combination With Platinum-taxane Doublet in Advanced Solid Tumor

The purpose of this study is to determine the recommended dose of the combination of AVE8062 with platinum salts (cisplatin or carboplatin) and taxanes (docetaxel or paclitaxel) in patient...

PubMed Articles [35382 Associated PubMed Articles listed on BioPortfolio]

Platinum single-agent vs. platinum-based doublet agent concurrent chemoradiotherapy for locally advanced cervical cancer: A meta-analysis of randomized controlled trials.

This study compared treatment outcomes and adverse events in patients with locally advanced cervical cancer undergoing radiotherapy (RT) with concurrent platinum-based doublet therapy vs. RT plus plat...

REPLATINUM Phase III randomized study: RRx-001 + platinum doublet versus platinum doublet in third-line small cell lung cancer.

RRx-001 is a cysteine-directed anticancer alkylating agent with activity in a Phase II study in platinum refractory small cell lung cancer. Here, we describe the design of REPLATINUM, an open-label, P...

Should platinum-based chemotherapy be preferred for germline BReast CAncer genes (BRCA) 1 and 2-mutated pancreatic ductal adenocarcinoma (PDAC) patients? A systematic review and meta-analysis.

Pancreatic ductal adenocarcinoma (PDAC) is one of the most lethal cancers worldwide. Recent studies have shown that 4-20% of patients with PDAC have a germline BReast CAncer (gBRCA) genes 1 and 2 muta...

Quantitative evaluation of the intratumoral distribution of platinum in oxaliplatin-treated rectal cancer: In situ visualization of platinum via synchrotron radiation X-ray fluorescence spectrometry.

Oxaliplatin, a platinum-based drug, is a key chemotherapeutic agent for colorectal cancer (CRC), but drug resistance and toxic effects have been major limitations of its use. Synchrotron radiation X-r...

Niraparib Maintenance Therapy in Patients With Recurrent Ovarian Cancer After a Partial Response to the Last Platinum-Based Chemotherapy in the ENGOT-OV16/NOVA Trial.

In the ENGOT-OV16/NOVA trial ( identifier: NCT01847274), maintenance therapy with niraparib, a poly(ADP-ribose) polymerase inhibitor, prolonged progression-free survival in patients...

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".

Inorganic compounds which contain platinum as the central atom.

The fusion of ceramics (porcelain) to an alloy of two or more metals for use in restorative and prosthodontic dentistry. Examples of metal alloys employed include cobalt-chromium, gold-palladium, gold-platinum-palladium, and nickel-based alloys.

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)

More From BioPortfolio on "A Study of Toripalimab or Placebo Plus Chemotherapy as Treatment in Early Stage NSCLC"

Quick Search

Relevant Topics

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Gilotrif (afatinib)
GILOTRIF (afatinib) is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L8...

Skin cancers
There are three main types of skin cancer: basal cell carcinoma, squamous cell carcinoma and malignant melanoma. Basal cell carcinoma Basal cell carcinoma, or BCC, is a cancer of the basal cells at the bottom of the epidermis. It’s very common ...

Searches Linking to this Trial