Treatment for advanced non-small cell lung cancer using Surufatinib with or without Vinorelbine

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

This study is testing if the drug Surufatinib, alone or with Vinorelbine, can help people with advanced non-small cell lung cancer who have already tried other treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University (Academic / other)
• Drugs / interventions: Surufatinib, chemotherapy, immunotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT04922658 on ClinicalTrials.gov

What this trial studies

This phase II study evaluates the efficacy and safety of Surufatinib, both alone and in combination with Vinorelbine, as a treatment option for patients with advanced non-small cell lung cancer (NSCLC) who have already undergone at least two prior systemic therapies. The study aims to determine how well these treatments work in this patient population and to assess any associated side effects. Participants will be closely monitored for measurable lesions and overall survival outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 80 with histologically confirmed advanced NSCLC who have experienced treatment failure or intolerable toxicities from at least two prior therapies.

Not a fit: Patients with small cell lung cancer or those who have previously received Surufatinib treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced NSCLC who have limited treatment choices.

How similar studies have performed: While this approach is being explored in this specific context, similar studies have shown promise in targeting advanced NSCLC with novel therapies, suggesting potential for success.

Eligibility criteria

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

Where this trial is running

Guangzhou, Guangdong

• Affiliated Cancer Hospital and Institute of Guangzhou Medical University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Yanfang Zheng, M.D., Ph.D. — Affiliated Cancer Hospital & Institute of Guangzhou Medical University
• Study coordinator: Yanfang Zheng, M.D., Ph.D.

Conditions Advanced Non-Small Cell Lung Cancer