A Study of Famitinib in Combination With HS-10296 in Patients With EGFR-mutant NSCLC

An Open, Single-arm, Multi-center, Phase 2 Clinical Trial of Famitinib Combined With Epidermal Growth Factor Receptor (EGFR) Inhibitor HS-10296 in Patients With Advanced EGFR-mutant Non-Small Cell Lung Cancer (NSCLC)

The study is being conducted to evaluate the efficacy, safety and tolerability of famitinib combined with HS-10296 in subjects with advanced EGFR-mutant NSCLC.

Inclusion Criteria:

• Subject's written informed consent obtained prior to any process, sampling, or analysis related to the study.
• Male or female, no less than 18 years old.
• Confirmed as NSCLC by histology or cytology.
• Locally advanced or metastatic NSCLC and not suitable for radical surgery or radiotherapy.
• Have not received EGFR Tyrosine Kinase Inhibitor (TKI) therapy.
• At least one baseline tumor lesion.
• Can swallow pills normally.
• Eastern Cooperative Oncology Group (ECOG) performance status 0~1 points, expected survival≥12 weeks.
• Adequate organ function.

Exclusion Criteria:

• Clinically symptomatic central nervous system metastases.
• Ascites, pleural effusion or pericardial effusion with clinical symptoms.
• Other malignant tumors in the past 5 years or at the same time.
• High blood pressure which are not well controlled.
• Heart disease that are not well controlled.
• Coagulation dysfunction, bleeding tendency or receiving thrombolysis or anticoagulant therapy.
• History of bleeding.
• Known hereditary or acquired bleeding and thrombophilia.
• Any serious or uncontrolled ocular lesion.
• Interstitial lung disease or non-infectious pneumonia treated with corticosteroids.
• Congenital or acquired immunodeficiency.
• Other factors that may affect the results of the study or cause the study to be terminated midway.