Small Cell Lung Cancer
Conditions
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).
Interventions
DRUGTORIPALIMAB INJECTION(JS001 ) Carboplatin Cisplatin Etoposide Placebo
TORIPALIMAB INJECTION(JS001 ) or Placebo combined with chemotherapy, 240mg/6ml/vial, Q3W,up to 2 years of treatment.
Sponsors
Shanghai Junshi Bioscience Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS (Progression Free Survival) by investigator | Approximately 2 years | Progression free survival (PFS) evaluated by investigators according to the response evaluation criteria in solid tumors (RECIST 1.1) |
| Overall suvival (OS) | Approximately 2.8 years | Overall suvival (OS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DOR (Duration of Response) | Approximately 2 years | Duration of response (DOR) evaluated by investigators and BIRC based on RECIST1.1; |
| DCR (Disease of Response) | Approximately 2 years | Disease control rate (DCR) evaluated by investigators and BIRC based on RECIST1.1; |
| TTR (Time to Response) | Approximately 2 years | Time to response (TTR) evaluated by investigators and BIRC based on RECIST1.1; |
| PFS (Progression Free Survival) per RECIST1.1 as Assessed by BIRC (Blinded Independent Review Board） | Approximately 2 years | PFS evaluated by the Blinded Individual Review Committee (BIRC) based on RECIST1.1 criteria; |
| Incidence of AEs/SAEs | Approximately 2 years | Adverse events (AEs) ; serious adverse events (SAEs); abnormal value of Lab test according to NCI-CTCAE V5.0 |
| PFS (Progression Free Survival) Rate | Approximately 1year | PFS rates at 6-month（inestigators and BICR） and at 1-year |
| OS (Overall Survival) rate | Approximately 2 years | OS rates at 1 and 2 years |
| ORR (Objective Response Rate) | Approximately 2 years | Objective response rate (ORR) evaluated by investigators and BIRC based on RECIST1.1; |
Countries
China
Outcome results
None listed