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

Advanced Non-Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04922658
• Other study ID #: HMPL-012-SPRING-L106
• Status: Recruiting
• Phase: Phase 2
• Start date: July 1, 2021
• Est. completion date: June 2025

Study information

• Verified date: August 2022
• Source: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
• Contact: Yanfang Zheng, M.D., Ph.D.
• Phone: 86-18665000236
• Email: 18665000236[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Advanced Non-Small Cell Lung Cancer
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Affiliated Cancer Hospital and Institute of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

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