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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04012606
Recruitment Status : Unknown
Verified September 2020 by Shanghai Junshi Bioscience Co., Ltd..
Recruitment status was:  Recruiting
First Posted : July 9, 2019
Last Update Posted : September 30, 2020
Sponsor:
Information provided by (Responsible Party):
Shanghai Junshi Bioscience Co., Ltd.

Study Description
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Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: TORIPALIMAB INJECTION(JS001 ) Carboplatin Cisplatin Etoposide Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 23, 2019
Estimated Primary Completion Date : July 6, 2021
Estimated Study Completion Date : June 18, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. PFS (Progression Free Survival) by investigator [ Time Frame: Approximately 2 years ]
    Progression free survival (PFS) evaluated by investigators according to the response evaluation criteria in solid tumors (RECIST 1.1)

  2. Overall suvival (OS) [ Time Frame: Approximately 2.8 years ]
    Overall suvival (OS)


Secondary Outcome Measures :
  1. PFS (Progression Free Survival) per RECIST1.1 as Assessed by BIRC (Blinded Independent Review Board） [ Time Frame: Approximately 2 years ]
    PFS evaluated by the Blinded Individual Review Committee (BIRC) based on RECIST1.1 criteria;

  2. ORR (Objective Response Rate) [ Time Frame: Approximately 2 years ]
    Objective response rate (ORR) evaluated by investigators and BIRC based on RECIST1.1;

  3. DOR (Duration of Response) [ Time Frame: Approximately 2 years ]
    Duration of response (DOR) evaluated by investigators and BIRC based on RECIST1.1;

  4. DCR (Disease of Response) [ Time Frame: Approximately 2 years ]
    Disease control rate (DCR) evaluated by investigators and BIRC based on RECIST1.1;

  5. TTR (Time to Response) [ Time Frame: Approximately 2 years ]
    Time to response (TTR) evaluated by investigators and BIRC based on RECIST1.1;

  6. OS (Overall Survival) rate [ Time Frame: Approximately 2 years ]
    OS rates at 1 and 2 years

  7. Incidence of AEs/SAEs [ Time Frame: Approximately 2 years ]
    Adverse events (AEs) ; serious adverse events (SAEs); abnormal value of Lab test according to NCI-CTCAE V5.0

  8. PFS (Progression Free Survival) Rate [ Time Frame: Approximately 1year ]
    PFS rates at 6-month（inestigators and BICR） and at 1-year


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04012606


Contacts
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Contact: Ying Cheng, prof +86431-8587-1902 jl.cheng@163.com

Locations
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China
Ying Cheng Recruiting
Chang chun, China
Sponsors and Collaborators
Shanghai Junshi Bioscience Co., Ltd.
More Information
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Responsible Party: Shanghai Junshi Bioscience Co., Ltd.
ClinicalTrials.gov Identifier: NCT04012606    
Other Study ID Numbers: JS001-028-III-SCLC
First Posted: July 9, 2019    Key Record Dates
Last Update Posted: September 30, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
 Bronchial Neoplasms
Carboplatin
Etoposide
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action