Toripalimab in Combination With Platinum Plus Etoposidein Patients With Extensive-Stage Small Cell Lung Cancer

A Phase III Randomized, Double-Blind, Placebo-controlled Study of Platinum(Cisplatin or Carboplatin) Plus Etoposide With or Without Toripalimab as First Line Therapy in Patients With ExtensiveStage Small Cell Lung Cancer

This is a phase III, multicenter, double-blinded, placebo-controlled study of platinum（Cisplatin or Carboplatin） plus etoposide with or without toripalimab as first Line therapy in patients with extensive stage small cell lung cancer.

The purpose of this study is to evaluate the safety and efficacy of toriplimab in combination with platinum（Cisplatin or Carboplatin） plus etoposide in treatment naive extensive stage small cell lung cancer.

Participants will receive asigned study treatment until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).

Study Overview

• Status: Unknown
• Conditions: Small Cell Lung Cancer
• Intervention / Treatment: Drug: TORIPALIMAB INJECTION(JS001 ) Carboplatin Cisplatin Etoposide Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 420
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ying Cheng, prof; Phone Number: +86431-8587-1902; Email: jl.cheng@163.com

Study Locations

• China
  • Chang chun, China
    • Recruiting
    • Ying Cheng

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. ≥18 years , male or female;
2. Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group (VALG) staging system
3. ECOG PS 0~1;
4. No prior treatment or immunocheckpoint inhibitors for ES-SCLC;
5. Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC；
6. Patients with asymptomatic brain metastases who have received previous treatment
7. Has provided tumor tissue samples
8. Estimated survival time ≥8 weeks;
9. There is at least one measurable lesion that conforms to RECIST criteria v1.1.For lesions that have received previous radiation therapy, the lesion can only be included in the measurable lesion if the disease progression is clear after radiotherapy and the lesion is not the only measurable lesion.
10. Before the first dose of the study drug, it should have appropriate organ function, and the laboratory test value should meet the protocol.
11. Has adequate hematologic and end organ function

Exclusion Criteria:

1. Prior systemtic treatment for ES-SCLC;
2. Prior treatment with any CD137 agnist or immunocheckpoint inhibitors.
3. Subjects with active or untreated central nervous system (CNS) tumor metastasis;
4. Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ≥ 1 week prior to randomization
5. Cancerous meningitis;
6. Uncontrolled or symptomatic hypercalcemia;
7. Other malignant tumors within 5 years prior to the first dose of study treatment
8. Subjects with any active, known or suspected autoimmune disease;
9. History of idiopathic pulmonary fibrosis, drug-induced pneumonitis,or evidence of active pneumonitis .
10. Subjects who received major surgery within 28 days prior to enrollment or were not fully recovered from prior surgery;
11. Significant cardiovascular disease, such as New York Heart Assoc

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Chemotherapy	Drug: TORIPALIMAB INJECTION(JS001 ) Carboplatin Cisplatin Etoposide Placebo; TORIPALIMAB INJECTION(JS001 ) or Placebo combined with chemotherapy, 240mg/6ml/vial, Q3W,up to 2 years of treatment.
Experimental: TORIPALIMAB	Drug: TORIPALIMAB INJECTION(JS001 ) Carboplatin Cisplatin Etoposide Placebo; TORIPALIMAB INJECTION(JS001 ) or Placebo combined with chemotherapy, 240mg/6ml/vial, Q3W,up to 2 years of treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS (Progression Free Survival) by investigator	Progression free survival (PFS) evaluated by investigators according to the response evaluation criteria in solid tumors (RECIST 1.1)	Approximately 2 years
Overall suvival (OS)	Overall suvival (OS)	Approximately 2.8 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS (Progression Free Survival) per RECIST1.1 as Assessed by BIRC (Blinded Independent Review Board）	PFS evaluated by the Blinded Individual Review Committee (BIRC) based on RECIST1.1 criteria;	Approximately 2 years
ORR (Objective Response Rate)	Objective response rate (ORR) evaluated by investigators and BIRC based on RECIST1.1;	Approximately 2 years
DOR (Duration of Response)	Duration of response (DOR) evaluated by investigators and BIRC based on RECIST1.1;	Approximately 2 years
DCR (Disease of Response)	Disease control rate (DCR) evaluated by investigators and BIRC based on RECIST1.1;	Approximately 2 years
TTR (Time to Response)	Time to response (TTR) evaluated by investigators and BIRC based on RECIST1.1;	Approximately 2 years
OS (Overall Survival) rate	OS rates at 1 and 2 years	Approximately 2 years
Incidence of AEs/SAEs	Adverse events (AEs) ; serious adverse events (SAEs); abnormal value of Lab test according to NCI-CTCAE V5.0	Approximately 2 years
PFS (Progression Free Survival) Rate	PFS rates at 6-month（inestigators and BICR） and at 1-year	Approximately 1year

Collaborators and Investigators

• Sponsor: Shanghai Junshi Bioscience Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2019
• Primary Completion (Anticipated): July 6, 2021
• Study Completion (Anticipated): June 18, 2022

Study Registration Dates

• First Submitted: July 5, 2019
• First Submitted That Met QC Criteria: July 8, 2019
• First Posted (Actual): July 9, 2019

Study Record Updates

• Last Update Posted (Actual): September 30, 2020
• Last Update Submitted That Met QC Criteria: September 28, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Carboplatin; Etoposide
• Other Study ID Numbers: JS001-028-III-SCLC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No