EGFR-mutant Non-Small Cell Lung CancerPhase 2NCT03904823
A Study of Famitinib in Combination With HS-10296 in Patients With EGFR-mutant NSCLC
A Phase 2 study testing famitinib po and HS-10296 po in people with EGFR-mutant Non-Small Cell Lung Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- EGFR-mutant Non-Small Cell Lung Cancer
- What is being tested?
- famitinib po and HS-10296 po
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2019to Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- Can swallow pills normally.
- Eastern Cooperative Oncology Group (ECOG) performance status 0~1 points, expected survival≥12 weeks.
- Adequate organ function.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji University, Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Caicun Zhou, PhD, 86-021-65115006 ext. 3050, caicunzhoudr@126.com
About this study
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)
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.
- Conditions
- EGFR-mutant Non-Small Cell Lung Cancer
- Being tested
- famitinib po, HS-10296 po
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
famitinib poDrug
Patients would be treated with famitinib po combined with HS-10296 po till progression disease or withdrawal from the study.
HS-10296 poDrug
Patients would be treated with famitinib po combined with HS-10296 po till progression disease or withdrawal from the study.
| Study group | Role | What they receive |
|---|---|---|
| famitinib, HS-10296 | Experimental | Not described Receives: Drug: famitinib po; Drug: HS-10296 po |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Measured: 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 outcomes (8)
Depth of Response (DepOR)
Percentage of total target lesion diameter reduced from baseline when at best overall response
Measured: 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)
Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Measured: 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)
Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Measured: 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)
Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Measured: From the start of treatment to 6 months
12-month-PFS
12-month-progression free survival rate
Measured: From the start of treatment to 12 months
Progression-Free-Survival (PFS)
Based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
Measured: up to 2 years
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
Measured: First cycle (21 days)
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
Measured: From the first drug administration to within 30 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start25 Apr 2019
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGFR-mutant Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Caicun Zhou, PhD, Principal investigator, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03904823
- Sponsor's protocol ID
- FMTN-II-203-NSCLC
- Status last verified
- Jun 2022
- First submitted
- 2 Apr 2019
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03904823
- Acronym / sponsor ID
- FMTN-II-203-NSCLC
- Conditions
- EGFR-mutant Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Apr 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 5 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| famitinib, HS-10296 | Experimental | Drug: famitinib po, Drug: HS-10296 po |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| famitinib poPatients would be treated with famitinib po combined with HS-10296 po till progression disease or withdrawal from the study. | Drug | famitinib, HS-10296 |
| HS-10296 poPatients would be treated with famitinib po combined with HS-10296 po till progression disease or withdrawal from the study. | Drug | famitinib, HS-10296 |
Primary outcome
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)
8 secondary outcomes
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
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
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
Clinical Benefit Ratio (CBR)
Time frame: From the start of treatment to 6 months
12-month-PFS
Time frame: From the start of treatment to 12 months
Progression-Free-Survival (PFS)
Time frame: up to 2 years
Number of Participants with Clinically significant toxicity
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
Related trials for EGFR-mutant Non-Small Cell Lung Cancer
RecruitingPhase 1/2
A Study of VRN110755 in Patients With EGFR-Mutant Non-Small Cell Lung Cancer
EGFR-Mutant Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC
EGFR-mutant Non-small Cell Lung Cancer
RecruitingPhase 3
Osimertinib With or Without Bevacizumab as Initial Treatment for Patients With EGFR-Mutant Lung Cancer
Advanced Lung Non-Squamous Non-Small Cell Carcinoma, Metastatic Lung Non-Squamous Non-Small Cell Carcinoma
RecruitingPhase 2
Osimertinib Plus Stereotactic Radiosurgery/Radiotherapy for EGFR-Mutant Non-Small Cell Lung Cancer With Symptomatic Brain Metastases
Non-Small Cell Lung Cancer, Brain Metastases From Non-small Cell Lung Cancer (NSCLC)
RecruitingPhase 3
Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy for EGFRmt Non-small Cell Lung Cancer (IZABRIGHT-Lung02)
Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caicun Zhou, PhD principal investigator
Shanghai Pulmonary Hospital, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing famitinib po and HS-10296 po in people with EGFR-mutant Non-Small Cell Lung Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Quanren Wang, PhD (+86 18036618570, wangquanren@hrglobe.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2022.