search
Back to results

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

Primary Purpose

EGFR-mutant Non-Small Cell Lung Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
famitinib po
HS-10296 po
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for EGFR-mutant Non-Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Tongji University, Shanghai Pulmonary HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

famitinib, HS-10296

Arm Description

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR)
Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)

Secondary Outcome Measures

Depth of Response (DepOR)
Percentage of total target lesion diameter reduced from baseline when at best overall response
Duration of Response (DOR)
Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Disease Control Rate (DCR)
Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Clinical Benefit Ratio (CBR)
Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
12-month-PFS
12-month-progression free survival rate
Progression-Free-Survival (PFS)
Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Number of Participants with Clinically significant toxicity
Number of Participants with Clinically significant toxicity per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0
Rate of Adverse Events and Serious Adverse Events
Rate of Adverse Events and Serious Adverse Events per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0

Full Information

First Posted
April 2, 2019
Last Updated
July 1, 2022
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT03904823
Brief Title
A Study of Famitinib in Combination With HS-10296 in Patients With EGFR-mutant NSCLC
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2019 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
EGFR-mutant Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
famitinib, HS-10296
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
famitinib po
Intervention Description
Patients would be treated with famitinib po combined with HS-10296 po till progression disease or withdrawal from the study.
Intervention Type
Drug
Intervention Name(s)
HS-10296 po
Intervention Description
Patients would be treated with famitinib po combined with HS-10296 po till progression disease or withdrawal from the study.
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
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
Secondary Outcome Measure Information:
Title
Depth of Response (DepOR)
Description
Percentage of total target lesion diameter reduced from baseline when at best overall response
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
Title
Duration of Response (DOR)
Description
Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Time Frame
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
Title
Disease Control Rate (DCR)
Description
Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
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
Title
Clinical Benefit Ratio (CBR)
Description
Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Time Frame
From the start of treatment to 6 months
Title
12-month-PFS
Description
12-month-progression free survival rate
Time Frame
From the start of treatment to 12 months
Title
Progression-Free-Survival (PFS)
Description
Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Time Frame
up to 2 years
Title
Number of Participants with Clinically significant toxicity
Description
Number of Participants with Clinically significant toxicity per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0
Time Frame
First cycle (21 days)
Title
Rate of Adverse Events and Serious Adverse Events
Description
Rate of Adverse Events and Serious Adverse Events per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0
Time Frame
From the first drug administration to within 30 days after the last dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Quanren Wang, PhD
Phone
+86 18036618570
Email
wangquanren@hrglobe.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Weixia Li, Master
Phone
+86 15005136260
Email
liweixia@hrglobe.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caicun Zhou, PhD
Organizational Affiliation
Shanghai Pulmonary Hospital, Shanghai, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tongji University, Shanghai Pulmonary Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caicun Zhou, PhD
Phone
86-021-65115006
Ext
3050
Email
caicunzhoudr@126.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs