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

• Status: Unknown status
• Trial end date: 2021-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Criteria

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.