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

NCT04922658 | Recruiting Phase 2

• 1 other identifier: HMPL-012-SPRING-L106
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Advanced Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Objective response rate (ORR)

  up to 12 months

• Disease control rate (DCR)

  up to 12 months

• Overall survival (OS)

  up to 36 months

Study Arms (2)

Surufatinib

EXPERIMENTAL

Drug: Surufatinib

Surufatinib plus Vinorelbine

EXPERIMENTAL

Drug: Surufatinib Plus Vinorelbine

Interventions

Surufatinib DRUG

Surufatinib,300mg, qd, po, 21 days for a cycle; continuous administration until PD, death or intolerable toxicity.

Surufatinib

Surufatinib Plus Vinorelbine DRUG

Surufatinib, 250mg, qd, po; Plus Vinorelbine, 20 mg, every 2 days; 21days for a cycle; continuous administration until PD, death or intolerable toxicity.

Surufatinib plus Vinorelbine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Affiliated Cancer Hospital & Institute of Guangzhou Medical University: lead

Study Sites (1)

Affiliated Cancer Hospital and Institute of Guangzhou Medical University

Guangzhou, Guangdong, 510095, China

RECRUITING

MeSH Terms

Interventions

surufatinib; Vinorelbine

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Yanfang Zheng, M.D., Ph.D.

  Affiliated Cancer Hospital & Institute of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanfang Zheng, M.D., Ph.D.

CONTACT

86-18665000236; 18665000236@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2021
• First Posted: June 10, 2021
• Study Start: July 1, 2021
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: July 31, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)