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

Hengrui Medicine

Status and phase

Enrolling

Phase 2

Conditions

EGFR-mutant Non-Small Cell Lung Cancer

Treatments

Drug: HS-10296 po

Drug: famitinib po

Study type

Interventional

Funder types

Industry

Identifiers

NCT03904823

FMTN-II-203-NSCLC

Details and patient eligibility

About

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.

Enrollment

58 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.