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)

Jiangsu HengRui Medicine Co., Ltd.1 site in 1 country58 target enrollmentApril 25, 2019

ConditionsEGFR-mutant Non-Small Cell Lung Cancer

Interventionsfamitinib po HS-10296 po

Drugsfamitinib po HS-10296 po

Overview

Phase: Phase 2
Intervention: famitinib po
Conditions: EGFR-mutant Non-Small Cell Lung Cancer
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Enrollment: 58
Locations: 1
Primary Endpoint: Objective Response Rate (ORR)
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 25, 2019

End Date

December 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Responsible Party

Sponsor

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.

Arms & Interventions

famitinib, HS-10296

Intervention: famitinib po

famitinib, HS-10296

Intervention: HS-10296 po

Outcomes

Primary Outcomes

Objective Response Rate (ORR)

Time Frame: From the start of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)

Secondary Outcomes

Disease Control Rate (DCR)(From the start of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months)
Clinical Benefit Ratio (CBR)(From the start of treatment to 6 months)
Duration of Response (DOR)(From the first partial response or complete response until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months)
12-month-PFS(From the start of treatment to 12 months)
Rate of Adverse Events and Serious Adverse Events(From the first drug administration to within 30 days after the last dose)
Number of Participants with Clinically significant toxicity(First cycle (21 days))
Depth of Response (DepOR)(From the start of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months)
Progression-Free-Survival (PFS)(up to 2 years)