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

Who is this study for? Patients with non-small cell lung cancer
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
RECRUITING
Guangzhou
Contact Information
Primary
Yanfang Zheng, M.D., Ph.D.
18665000236@163.com
86-18665000236
Time Frame
Start Date: 2021-07-01
Estimated Completion Date: 2025-06
Participants
Target number of participants: 60
Treatments
Experimental: Surufatinib
Experimental: Surufatinib plus Vinorelbine
Sponsors
Leads: Affiliated Cancer Hospital & Institute of Guangzhou Medical University

This content was sourced from clinicaltrials.gov