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

  • STATUS
    Recruiting
  • End date
    Jun 21, 2024
  • participants needed
    60
  • sponsor
    Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Updated on 21 August 2021

Summary

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

Details
Condition Advanced Non Small Cell Lung Cancer
Treatment Surufatinib, Surufatinib Plus Vinorelbine
Clinical Study IdentifierNCT04922658
SponsorAffiliated Cancer Hospital & Institute of Guangzhou Medical University
Last Modified on21 August 2021

Eligibility

Yes No Not Sure

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 ULNcreatinine<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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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