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

Phase 2

• Conditions: EGFR-mutant Non-Small Cell Lung Cancer
• Interventions: Drug: famitinib po; Drug: HS-10296 po

• Registration Number: NCT03904823
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-02
• Study First Submitted QC: 2019-04-03
• Study First Posted: 2019-04-05
• Study Start: 2019-04-25
• Status Verified: 2022-06
• Last Update Submitted: 2022-07-01
• Last Update Posted: 2022-07-07
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 58

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
famitinib, HS-10296	HS-10296 po	-
famitinib, HS-10296	famitinib po	-

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	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 Outcome Measures

Name	Time	Method
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	Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Clinical Benefit Ratio (CBR)	From the start of treatment to 6 months	Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
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	Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
12-month-PFS	From the start of treatment to 12 months	12-month-progression free survival rate
Rate of Adverse Events and Serious Adverse Events	From the first drug administration to within 30 days after the last dose	Rate of Adverse Events and Serious Adverse Events per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0
Number of Participants with Clinically significant toxicity	First cycle (21 days)	Number of Participants with Clinically significant toxicity per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0
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	Percentage of total target lesion diameter reduced from baseline when at best overall response
Progression-Free-Survival (PFS)	up to 2 years	Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)

Trial Locations

Locations (1)

Tongji University, Shanghai Pulmonary Hospital; 🇨🇳 Shanghai, Shanghai, China