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

NCT04012606 | Completed Phase 3

• 1 other identifier: JS001-028-III-SCLC
• Study Type: interventional
• Target: 442
• Locations: 1 country
• Sites: 1

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).

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• PFS (Progression Free Survival) per RECIST1.1 as Assessed by BIRC (Blinded Independent Review Board）

  Approximately 2 years

• ORR (Objective Response Rate)

  Approximately 2 years

• DOR (Duration of Response)

  Approximately 2 years

• DCR (Disease of Response)

  Approximately 2 years

• TTR (Time to Response)

  Approximately 2 years

Study Arms (2)

TORIPALIMAB

EXPERIMENTAL

Drug: TORIPALIMAB INJECTION(JS001 ) Carboplatin Cisplatin Etoposide Placebo

Chemotherapy

ACTIVE COMPARATOR

Drug: TORIPALIMAB INJECTION(JS001 ) Carboplatin Cisplatin Etoposide Placebo

Interventions

TORIPALIMAB INJECTION(JS001 ) Carboplatin Cisplatin Etoposide Placebo DRUG

TORIPALIMAB INJECTION(JS001 ) or Placebo combined with chemotherapy, 240mg/6ml/vial, Q3W,up to 2 years of treatment.

Chemotherapy; TORIPALIMAB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years , male or female;
• Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group (VALG) staging system
• ECOG PS 0\~1;
• No prior treatment or immunocheckpoint inhibitors for ES-SCLC;
• 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；
• Patients with asymptomatic brain metastases who have received previous treatment
• Has provided tumor tissue samples
• Estimated survival time ≥8 weeks;
• 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.
• Before the first dose of the study drug, it should have appropriate organ function, and the laboratory test value should meet the protocol.
• Has adequate hematologic and end organ function

You may not qualify if:

• Prior systemtic treatment for ES-SCLC;
• Prior treatment with any CD137 agnist or immunocheckpoint inhibitors.
• Subjects with active or untreated central nervous system (CNS) tumor metastasis;
• 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
• Cancerous meningitis;
• Uncontrolled or symptomatic hypercalcemia;
• Other malignant tumors within 5 years prior to the first dose of study treatment
• Subjects with any active, known or suspected autoimmune disease;
• History of idiopathic pulmonary fibrosis, drug-induced pneumonitis,or evidence of active pneumonitis .
• Subjects who received major surgery within 28 days prior to enrollment or were not fully recovered from prior surgery;
• Significant cardiovascular disease, such as New York Heart Assoc

Sponsors & Collaborators

• Shanghai Junshi Bioscience Co., Ltd.: lead

Study Sites (1)

Ying Cheng

Changchun, China

Location

Related Publications (1)

• Cheng Y, Zhang W, Wu L, Zhou C, Wang D, Xia B, Bi M, Fu X, Li C, Lv D, Zhao Y, Chen G, Yi T, Huang J, Li M, Yang R, Huang X, Wang Y, Zhang M, Pan Y, Sun Y, Hu S, Zhang X, Zhou M, Fang J, Jin F, Liu Y, Li Y, Zhang Z, Hu J, Liu L, Wang R, Li Y, Gu K, Ding C, Fan Q, Zhang G, Chen Y, Jiang L, Zheng WE, Chen S, Huang C, Han Z, Yang H, Wang J, Wang B, Wu H, Bao Y, Li M, Luo X, Gu S, Yu W, Xu K, Zhang S, Yu J. Toripalimab Plus Chemotherapy as a First-Line Therapy for Extensive-Stage Small Cell Lung Cancer: The Phase 3 EXTENTORCH Randomized Clinical Trial. JAMA Oncol. 2025 Jan 1;11(1):16-25. doi: 10.1001/jamaoncol.2024.5019.

  PMID: 39541202 DERIVED

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2019
• First Posted: July 9, 2019
• Study Start: July 23, 2019
• Primary Completion: April 20, 2023
• Study Completion: April 20, 2023
• Last Updated: January 16, 2025

Record last verified: 2025-01

Locations

CN (1)