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

NCT ID: NCT03904823

Last Updated: 2022-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-25
• Study Completion Date: 2022-12-31

Brief 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.

Conditions

EGFR-mutant Non-Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

famitinib, HS-10296

Group Type: EXPERIMENTAL

famitinib po

Intervention Type: DRUG

Patients would be treated with famitinib po combined with HS-10296 po till progression disease or withdrawal from the study.

HS-10296 po

Intervention Type: DRUG

Patients would be treated with famitinib po combined with HS-10296 po till progression disease or withdrawal from the study.

Interventions

famitinib po

Patients would be treated with famitinib po combined with HS-10296 po till progression disease or withdrawal from the study.

Intervention Type: DRUG

HS-10296 po

Patients would be treated with famitinib po combined with HS-10296 po till progression disease or withdrawal from the study.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caicun Zhou, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Pulmonary Hospital, Shanghai, China

Locations

Tongji University, Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Quanren Wang, PhD

Role: CONTACT

wangquanren@hrglobe.cn

+86 18036618570

Weixia Li, Master

Role: CONTACT

liweixia@hrglobe.cn

+86 15005136260

Facility Contacts

Caicun Zhou, PhD

Role: primary

caicunzhoudr@126.com

86-021-65115006 ext. 3050

Other Identifiers

FMTN-II-203-NSCLC

Identifier Type: -

Identifier Source: org_study_id