Surufatinib or Surufatinib Combined With Vinorelbine for Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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A phase II study to assess the efficacy and safety of Surufatinib or Surufatinib combined with Vinorelbine as third-line and posterior line treatment in patients with NSCLC

Official Title
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A Phase II, Single-arm, Two-cohorts, Open-label, Single Center Study of Surufatinib or Surufatinib Combined With Vinorelbine as Third-line and Posterior Line Treatment in Patients With Non-Small Cell Lung Cancer

Conditions
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Advanced Non-Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Surufatinib
* Drug: Surufatinib Plus Vinorelbine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of written Informed Consent Form (ICF) prior to any study specific procedures Age ≥ 18 years, ≤80 years Histologically or cytologically confirmed advanced NSCLC At least two or more systemic therapies prior treatment of cytotoxic chemotherapy, treatment failure or intolerable toxicities ECOG 0-2 Patients must have measurable lesions Expected overall survival ≥6 months AST, ALT and alkaline phosphatase ≤ 2.5 times the upper limit of normal (ULN)，Serum bilirubin ≤ 1.5 x ULN，creatinine<ULN Prothrombin time (PT), international standard ratio (INR) ≤1.5 × ULN Women of childbearing age must be willing to use adequate contraceptives during the study period of drug treatment Exclusion Criteria: Patients have received Surufatinib treatment Patients with small cell lung cancer (including mixed small cell lung cancer and non-small cell lung cancer) EGFR mutation /ALK rearrangement positive but not using relevant targeted drugs Central squamous cell carcinoma with cavity or non-small cell lung cancer with hemoptysis (> 50 ml / D) 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) 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 systolic blood pressure > 140mmHg or diastolic blood pressure > 90mmHg regardless of any antihypertensive drugs; Or patients need more than two antihypertensive drugs Clinically significant electrolyte abnormality Proteinuria ≥ 2+ (1.0g/24hr) Patients have untreated central nervous system metastasis Received any operation or invasive treatment or operation (except venous catheterization, puncture and drainage, etc.) within 4 weeks before enrollment 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 Dysphagia or known malabsorption of drugs Active gastric and duodenal ulcer, ulcerative colitis or uncontrolled hemorrhage in GI 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 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); Pregnant or lactating women Allergic to Surufatinib/Vinorelbine History of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, or organ transplantation 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 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 Serious psychological or mental disorders that may affect the compliance study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surufatinib<br> | Drug: Surufatinib<br>* Surufatinib,300mg, qd, po, 21 days for a cycle; continuous administration until PD, death or intolerable toxicity.<br>|
| Experimental: Surufatinib plus Vinorelbine<br> | Drug: Surufatinib Plus Vinorelbine<br>* Surufatinib, 250mg, qd, po; Plus Vinorelbine, 40 mg , each week d1, d3, d5; 21days for a cycle; continuous administration until PD, death or intolerable toxicity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) | 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). | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) | CR + PR rate according to the RECIST version 1.1 guidelines. | up to 12 months | 
| Disease control rate (DCR) | CR + PR + SD rate according to the RECIST version 1.1 guidelines. | up to 12 months | 
| Overall survival (OS) | The time interval between the start date of study drug and the date of death (any cause) | up to 36 months |