small cell lung cancer
Conditions
Interventions
Tislelizumab + standard chemotherapy:Tislelizumab + standard chemotherapy
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed ES-SCLC (American Joint Cancer Committee (7th Edition) Stage IV SCLC [any T, any N and M1a/b]), or T3-4 patients who are unable to be included in a tolerable radiotherapy program due to multiple lung resolution or excessive tumor volume. Patients with brain metastases must have asymptomatic or stable steroid and anticonvulsant treatment for at least 1 month before study treatment. Patients with suspected brain metastasis during screening should undergo brain CT/MRI examination before enrollment of the study; 2. PD-L1 expression and tumor-related 1021 driver genes (NGS, including TMB) were determined by the IHC test of previously acquired archived tumor tissue or biopsy tissue obtained during screening in the central laboratory. Patients who progressed after treatment need a second biopsy (optional); (1). A representative FFPE tumor specimens embedded in paraffin blocks (preferred) or >=15 fresh unstained serial sections from a FFPE tumor specimen are required for enrollment. If the available sections at baseline are =3 needle core specimens embedded in a single paraffin block for evaluation; 3. There are measurable diseases defined in RECIST version 1.1; 4. ECOG's physical fitness status is 0 points or 1 point; 5 .Male or female patients aged >=18 years; 6. Appropriate hematological and terminal organ functions are defined by the following laboratory test results obtained within 14 days before randomization: (1). ANC >= 1,500 cells/µL without the support of granulocyte colony stimulator; (2). Lymphocyte count >=500/µL; (3). In the absence of blood transfusion, platelet count >=100,000/µL; (4). Hemoglobin >=9 g/dL, blood transfusions can be performed to meet this standard; (5). INR or aPTT 60mL/min and patients treated with carboplatin are >45mL/min: Male: Creatinine CL (mL/min) = weight (kg) × (140-age)/72×Serum creatinine (mg/dL); Female: Creatinine CL (mL/min) = weight (kg) x (140-age) × 0.85/72 × serum creatinine (mg/dL) 7. For female patients with fertility, (patient and/or partner) agree to use a highly efficient (<1%/year) contraceptive if used continuously and correctly, low failure rate (<1%/year)) contraceptive and continue to use this cont
Exclusion criteria
Exclusion criteria: 1. Have a history of chest radiotherapy or plan to undergo intensive chest radiotherapy before systemic treatment. Radiotherapy outside the chest (ie, bone metastasis) is allowed for palliative care purposes, however, must be done before the first medication of the study drug; 2. Spinal cord compression without surgical and/or radiation treatment, or previous confirmed and treated spinal cord compression, and no evidence suggests that pre-randomization disease has been clinically stable for >2 weeks; 3. Concurrently perform any chemotherapy, IP, biological products or hormone therapy for cancer treatment. It is acceptable to use hormone therapy for non-cancer-related conditions (eg, hormone replacement therapy); 4. Uncontrolled tumor-related pain; (1). Patients who require painkillers must have a stable treatment plan when enrolling the study; (2). Symptoms of lesions suitable for palliative radiotherapy (e.g., bone metastasis or metastasis that causes nerve impairment) should have been treated prior to randomization. The patient should have recovered from the effects of radiotherapy. No minimum recovery period requirement; (3). Further growth of asymptomatic metastatic lesions may cause functional deficits or refractory pain (e.g., epidural metastasis not currently accompanied by spinal cord compression), and local regional treatment should be considered as appropriate before randomization; 5. Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage operations (once a month or more frequently); 6. Uncontrolled or symptomatic hypercalcemia (ionic calcium ?1.5 mmol/L or calcium ?12 mg/dL or corrected serum calcium >ULN). Patients who are receiving desalumumab prior to randomization must be willing and able to receive bisphosphonate instead of desalumumab in the study; 7. Randomization with malignant tumors other than SCLC within the first 5 years, but the risk of metastasis or death is negligible (e.g., expected 5-year OS ?90%) and with cured outcomes after treatment (e.g., well-treated cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer receiving radical surgery, ductal carcinoma in situ treated with radical surgery); General exclusion criteria: 8. Hypersensitivity to any component in tirelizumab, cisplatin, carboplatin, other platinum-containing compounds and etoposide or to any component in the container; 9. History of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granuloma, Sjögren's syndrome, Guillen's syndrome, multiple sclerosis, vasculitis or glomerulonephritis. (1). Patients with a history of autoimmune-related hypothyroidism and are receiving stable doses of thyroid hormone replacement therapy are selected; (2). Patients with controlled type 1 diabetes who are receiving a stable dose of insulin regimen are selected; (3). Patients with eczema, psoriasis, chronic lemons, or vitiligo only manifestations of skin disease (e.g., patients with psoriatic arthritis will be excluded) are allowed to be selected for this study, provided that these patients meet the following conditions: 1). The surface area covered by the rash must be <10%; 2). The disease has been well controlled at baseline and only inefficient topical steroids are required; 3). There has been no a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Progression-free survival rate;Disease control rate;Overall survival rate; | — |
Countries
China
Contacts
Public ContactChen Lijuan
Henan Cancer Hospital
Outcome results
None listed