Extensive-stage small cell lung cancer
Conditions
Interventions
Group 1:BL0020 Injection 25mg/m^2, intravenous infusion, Toripalimab Injection 240 mg, intravenous infusion, once every 3 weeks.
Group 2:BL0020 Injection 20mg/m^2, intravenous infusion, Toripalimab Injection 240 mg, intravenous infusion, once every 3 weeks.
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntary participation in the trial, understanding the specific procedures of the trial and signing the informed consent form. 2. Aged >= 18 years, gender not restricted. 3. Weight > 45 kg. 4. Histologically or cytologically confirmed extensive-stage small cell lung cancer (according to the VA Lung Cancer Group (VALG) staging system), with extensive-stage small cell lung cancer stage only having relapsed or progressed after receiving a first-line platinum-based systemic treatment regimen. 5. According to RECIST v1.1, at least one measurable lesion exists. Note: Measurable lesions should not include those that have received previous radiotherapy, those that have undergone other local treatments, or those that underwent biopsy within 2 weeks prior to screening. If the only available target lesion is the one from the previous radiotherapy area or the one that has received other local treatments, the researchers need to confirm that this lesion has clearly progressed and is measurable. 6. The Eastern Cooperative Oncology Group (ECOG) status score at screening is 0 or 1. 7. The expected survival time is >= 12 weeks. 8. Male participants must agree to take adequate contraceptive measures from screening until 6 months after the last administration of the investigational drug. 9. Female participants with potential fertility must have a negative pregnancy test result at screening and agree to take adequate contraceptive measures from screening until 6 months after the last administration of the investigational drug. Female participants without potential fertility are defined as those meeting any of the following criteria: (1) Age = 60 years, with continuous amenorrhea for >= 12 months; (2) Age = 12 months and follicle-stimulating hormone (FSH) at post-menopausal levels; (3) Had bilateral oophorectomy, hysterectomy, or bilateral fallopian tube resection more than 6 weeks before screening.
Exclusion criteria
Exclusion criteria: 1. Without chemotherapy interval (CTFI: the time from the last administration of platinum-based chemotherapy to the occurrence of disease progression, regardless of whether maintenance treatment with immune checkpoint inhibitors is received). 2. Histological or cytological confirmed combined small cell lung cancer and transformed small cell lung cancer. 3. Subjects with central nervous system (CNS) metastasis or cancerous meningitis. Note: Subjects with asymptomatic CNS metastasis, if they meet the following criteria simultaneously, can participate in this trial: (1) If the subject completed radiotherapy or surgery for CNS metastasis more than 4 weeks before the administration of the first trial drug, and the neurological condition of the subject was stable for >= 4 weeks (i.e., no new neurological deficits due to brain metastasis were found at the time of screening, no new lesions were detected on CNS imaging examination, and no high-dose corticosteroids (> 10 mg/day prednisone or equivalent drugs) were required for treatment within 4 weeks before screening), then they can participate in this trial; (2) Only metastases in the cerebellum or supratentorial regions (i.e., no metastasis in the midbrain, pons, medulla oblongata or spinal cord). 4. Spinal cord compression that is not curatively treated by surgery and/or radiotherapy, or if the previously diagnosed spinal cord compression has no clinical evidence of disease stability >= 2 weeks before the administration of the first trial drug. 5. Subjects with a history of other primary malignant tumors (excluding cured skin basal cell carcinoma, skin squamous cell carcinoma or cervical carcinoma in situ), if they have no evidence of disease for 3 years or more and do not require treatment for other in situ cancers. 6. Subjects who had or currently have autoimmune diseases (such as Crohn's disease, ulcerative colitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, glomerulonephritis). The following subjects are eligible to participate in the trial: (1) Subjects with a history of autoimmune-related hypothyroidism who are receiving thyroid hormone replacement therapy; (2) Subjects with type 1 diabetes who have their condition controlled by a stable insulin regimen; (3) Vitiligo. 7. Subjects whose imaging shows that the tumor has invaded the perivascular area of important blood vessels, and the investigator judges that the tumor is highly likely to invade important blood vessels and cause fatal massive hemorrhage during the subsequent clinical trial period. 8. Uncontrolled pericardial effusion, pleural effusion or peritoneal effusion after treatment. 9. Subjects with a history of allogeneic transplantation (including but not limited to allogeneic organ, bone marrow transplantation or stem cell transplantation). 10. Subjects with Gilbert syndrome. 11. Subjects with homozygous or heterozygous mutations of UGT1A1*28 or UGT1A1*6 alleles. 12. Severe cardiovascular and cerebrovascular diseases, including: (1) NYHA classification of grade III-IV cardiac insufficiency or left ventricular ejection fraction 480
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability (Incidence and severity of adverse events, etc.);maximum tolerated dose (MTD), recommended dose for phase III clinical trials; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate (DCR);Progression?free survival (PFS);Objective response rate (ORR);Duration of response (DOR);12?month overall survival rate (OS12);Overall survival (OS); | — |
Countries
China
Contacts
Public ContactZiming Li
Shanghai Chest Hospital
Outcome results
None listed