Lung Cancer Clinical Trial
Official title:
An Open-label, Multicenter Phaseâ…¡ Study of SHR-1701 in Combination With or Without Famitinib Malate for the Treatment of Extensive Stage Small Cell Lung Cancer After Previous Systemic Chemotherapy Failure
The study is being conducted to evaluate the efficacy and safety of SHR-1701 in combination with or without famitinib malate for the treatment of extensive stage small cell lung cancer after the failure of previous systemic chemotherapy
Status | Not yet recruiting |
Enrollment | 106 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Patients voluntarily participated in the clinical study, understood the study procedures and are able to sign the informed consent form. 2. 18 to 75 years old, male or female. 3. Histologically or cytologically confirmed extensive stage small cell lung cancer(ED-SCLC). 4. ECOG Performance Status of 0 or 1. 5. Adequate hematological, hepatic and renal function. 6. Female subjects of child-bearing potential must have a negative serum HCG test before treatment. Exclusion Criteria: 1. Histologically or cytologically confirmed mixed SCLC and NSCLC. 2. Untreated central nervous system metastases. 3. Cancerous meningitis (meningeal metastasis). 4. Uncontrolled pleural effusion, pericardial effusion or ascites. 5. Tumor infiltration into the great vessels on imaging; 6. Hemoptysis symptoms and maximum daily hemoptysis = 2.5ml occurred within 1 month. 7. Uncontrolled tumor-related pain. 8. Malignancies other than SCLC within 5 years. 9. Systemic antitumor therapy was received 4 weeks prior to trial treatment. 10. History of autoimmune diseases. 11. Significant cardiovascular disease. 12. Inadequately controlled hypertension. 13. Known history of testing positive test for HIV or known AIDS. 14. Patients with active hepatitis B or hepatitis C 15. Severe infections within 4 weeks prior to trial treatment. 16. Active tuberculosis. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
---|---|
Jiangsu HengRui Medicine Co., Ltd. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective response rate (ORR) based on RECIST 1.1 criteria | up to approximately 1 year. | ||
Secondary | Progression free survival (PFS) based on RECIST 1.1 criteria | up to approximately 1 year. | ||
Secondary | Disease control rate (DCR) based on RECIST 1.1 criteria | up to approximately 1 year. | ||
Secondary | Duration of response (DoR) | up to approximately 1 year | ||
Secondary | Overall survival (OS) | up to approximately 1 year | ||
Secondary | AEs+ SAEs determined by NCI-CTCAE V5.0 | Baseline until up to 90 days after end of treatment. |
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