A phase II study to assess the efficacy and safety of Surufatinib or Surufatinib combined with Vinorelbine as athird-line and posterior line treatment in patients with NSCLC
Full Title of Study: “A Phase II, Single-arm, Two-cohorts, Open-label, Single Center Study of Surufatinib or Surufatinib Combined With Vinorelbine as a Third-line and Posterior Line Treatment in Patients With Non-Small Cell Lung Cancer”
- Study Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: December 2022
- Drug: Surufatinib
- Surufatinib,250mg ,qd,po,21 days for a cycle,.continuous administration until PD, death or intolerable toxicity.
- Drug: Surufatinib Plus Vinorelbine
- Surufatinib,250mg ,qd,po,21 days for a cycle; Vinorelbine, 60 mg / m2 BSA, d1,q3w; continuous administration until PD, death or intolerable toxicity.
Arms, Groups and Cohorts
- Experimental: Surufatinib
- Experimental: Surufatinib plus Vinorelbine
Clinical Trial Outcome Measures
- Progression-free survival (PFS)
- Time Frame: up to 12 months
- To assess the efficacy of Surufatinib or Surufatinib Combined With Vinorelbine for NSCLC , patients by assessment of progression free survival (PFS) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
- Objective response rate (ORR)
- Time Frame: up to 12 months
- CR + PR rate according to the RECIST version 1.1 guidelines.
- Disease control rate (DCR)
- Time Frame: up to 12 months
- CR + PR + SD rate according to the RECIST version 1.1 guidelines.
- Overall survival (OS)
- Time Frame: up to 36 months
- The time interval between the start date of study drug and the date of death (any cause)
Participating in This Clinical Trial
1. Provision of written Informed Consent Form (ICF) prior to any study specific procedures 2. Age ≥ 18 years, ≤80 years 3. Histologically or cytologically confirmed advanced NSCLC 4. At least two or more systemic therapies prior treatment of cytotoxic chemotherapy, treatment failure or intolerable toxicities 5. ECOG 0-2 6. Patients must have measurable lesions 7. Expected overall survival ≥6 months 8. AST, ALT and alkaline phosphatase ≤ 2.5 times the upper limit of normal (ULN)，Serum bilirubin ≤ 1.5 x ULN，creatinine<ULN 9. Prothrombin time (PT), international standard ratio (INR) ≤1.5 × ULN 10. Women of childbearing age must be willing to use adequate contraceptives during the study period of drug treatment Exclusion Criteria:
1. Patients have received Surufatinib treatment 2. Patients with small cell lung cancer (including mixed small cell lung cancer and non-small cell lung cancer) 3. EGFR mutation /ALK rearrangement positive but not using relevant targeted drugs 4. Central squamous cell carcinoma with cavity or non-small cell lung cancer with hemoptysis (> 50 ml / D) 5. Have received other systemic anti-tumor therapies within 2 weeks before recruited(eg.chemotherapy or radiotherapy, immunotherapy, biological or hormonal therapy, or any VEGFR inhibitor treatment) 6. Participated in the clinical trials of other drugs that have not been approved or marketed in China and received the corresponding experimental drug treatment within 2 weeks before enrollment 7. systolic blood pressure > 140mmHg or diastolic blood pressure > 90mmHg regardless of any antihypertensive drugs; Or patients need more than two antihypertensive drugs 8. Clinically significant electrolyte abnormality 9. Proteinuria ≥ 2+ (1.0g/24hr) 10. Patients have untreated central nervous system metastasis 11. Received any operation or invasive treatment or operation (except venous catheterization, puncture and drainage, etc.) within 4 weeks before enrollment 12. Patients have not recovered from all toxicities associated with prior anti-tumor therapy ,to acceptable baseline status, or a National Cancer Institute Common Terminology Criteria for Adverse Events(NCI CTCAE v5.0) Grade of 0 or 1, except for alopecia and oxaliplatin induced neurotoxicity ≤ 2 , and the previous surgery did not recover completely 13. Dysphagia or known malabsorption of drugs 14. Active gastric and duodenal ulcer, ulcerative colitis or uncontrolled hemorrhage in GI 15. Have evidence or history of bleeding tendency within 2 months after enrollment, the researcher assessed that moderate or severe bleeding tendency was not suitable for enrollment 16. Patients had other malignant tumors in the past 5 years or at the same time (except for the cured skin basal cell carcinoma and cervical carcinoma in situ); 17. Pregnant or lactating women 18. Allergic to Surufatinib/Vinorelbine 19. History of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, or organ transplantation 20. Patients with acute myocardial infarction, severe / unstable angina pectoris or coronary artery bypass grafting within 6 months before admission; Or a history of arterial thrombosis or deep venous thrombosis 21. There are concomitant diseases (such as severe hypertension, diabetes, thyroid disease, active infection, etc.) that seriously endanger the safety of patients or affect the completion of the study, or any laboratory abnormalities that are not suitable for participating in the clinical trial according to the judgment of the researcher 22. Serious psychological or mental disorders that may affect the compliance study
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 80 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Affiliated Cancer Hospital & Institute of Guangzhou Medical University
- Provider of Information About this Clinical Study
- Overall Official(s)
- Yanfang Zheng, M.D., Ph.D., Principal Investigator, Affiliated Cancer Hospital & Institute of Guangzhou Medical University
- Overall Contact(s)
- Yanfang Zheng, M.D., Ph.D., 86-18665000236, firstname.lastname@example.org
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