Status:
COMPLETED
Toripalimab in Combination With Platinum Plus Etoposidein Patients With Extensive-Stage Small Cell Lung Cancer
Lead Sponsor:
Shanghai Junshi Bioscience Co., Ltd.
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 exten...
Eligibility Criteria
Inclusion
- ≥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
Exclusion
- 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
Key Trial Info
Start Date :
July 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2023
Estimated Enrollment :
442 Patients enrolled
Trial Details
Trial ID
NCT04012606
Start Date
July 23 2019
End Date
April 20 2023
Last Update
January 16 2025
Active Locations (1)
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1
Ying Cheng
Changchun, China