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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 25, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 5, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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