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

July 1, 2022 updated by: Jiangsu HengRui Medicine Co., Ltd.

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

58

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Recruiting
        • Tongji University, Shanghai Pulmonary Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: famitinib, HS-10296
Drug: famitinib po
Patients would be treated with famitinib po combined with HS-10296 po till progression disease or withdrawal from the study.
Drug: HS-10296 po
Patients would be treated with famitinib po combined with HS-10296 po till progression disease or withdrawal from the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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 Measures

Outcome Measure
Measure Description
Time Frame
Depth of Response (DepOR)
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
Percentage of total target lesion diameter reduced from baseline when at best overall response
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
Duration of Response (DOR)
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
Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
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
Disease Control Rate (DCR)
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)
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)
Time Frame: From the start of treatment to 6 months
Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
From the start of treatment to 6 months
12-month-PFS
Time Frame: From the start of treatment to 12 months
12-month-progression free survival rate
From the start of treatment to 12 months
Progression-Free-Survival (PFS)
Time Frame: up to 2 years
Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
up to 2 years
Number of Participants with Clinically significant toxicity
Time Frame: 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
First cycle (21 days)
Rate of Adverse Events and Serious Adverse Events
Time Frame: 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
From the first drug administration to within 30 days after the last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 25, 2019

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

April 2, 2019

First Submitted That Met QC Criteria

April 3, 2019

First Posted (ACTUAL)

April 5, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 7, 2022

Last Update Submitted That Met QC Criteria

July 1, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMTN-II-203-NSCLC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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