NSCLCPhase 3AFLCNCT03428022
Apatinib Combined With EGFR-TKI for Advanced Slow-progressed EGFR-TKI Resistant NSCLC
A Phase 3 study testing Apatinib（Tab. 500mg/d） combined with EGFR-TKI（as previously） in people with NSCLC and Apatinib, run by Shenzhen People's Hospital at 1 site in China.
Trial summary
Patients with advanced non-small cell lung cancer (NSCLC) who progress slowly after Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors（EGFR-TKI）resistance will be treated with Apatinib and EGFR-TKI. The primary objective is the disease progression free survival of the patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Apatinib（Tab. 500mg/d） combined with EGFR-TKI（as previously）
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2017to 31 Dec 2020
- Phase
- Phase 3
- 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
- Pathologically confirmed advanced (stage IV) non-squamous, non-small cell lung cancer with measurable lesions
- Electronics Coordinating Grop（ECOG）score：0-2
- Expected survival over 3months
- Hemoglobin(HB)≥90 gram(g)/liter(L)；absolute neutrophil count(ANC)≥1.5×109/L；platelet(PLT)≥80×109/L；total-bilirubin（T-BIL）<1.5 upper limit of normal value（ULN）；alanine aminotransferase（ALT）and aspartate aminotransferase（AST）<2.5 ULN；Cr≤1.25ULN
Who cannot join
- Brain metastases, meningococcal meningitis, patients with spinal cord compression with evidence of imaging (computed tomography（CT） / magnetic resonance imaging （MRI）, et cetera（etc.）);
- Uncontrolled hypertension (systolic blood pressure（BP）≥140 millimeter mercury column（mmHg） or diastolic BP ≥90 mmHg, despite optimal drug therapy);
- Hemorrhoid dysfunction (inernational standard ratio(INR)> 1.5 or prothrombin time (PT)> ULN + 4 seconds or activated partial thromboplastin(APTT)> 1.5 ULN) with bleeding tendency or undergoing thrombolytic or anticoagulant therapy;
- Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or the like;
- Patients underwent major surgery or severe traumatic injury, fracture or ulcer in 4 weeks before study;
- Urine routine urine protein ≥ +++, or confirmed 24 hours urinary protein content ≥ 1.0 g;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020
CAO HUA, MD, 0086-755-22942406, caohua1206@hotmail.com
About this study
Official title: Apatinib Combined With Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors Used for the Advanced Slow-progressed Non Small Cell Lung Cancer Patients With EGFR-TKI Resistance
Patients with advanced non-small cell lung cancer (NSCLC) who progress slowly after Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors（EGFR-TKI）resistance will be treated with Apatinib and EGFR-TKI. The primary objective is the disease progression free survival of the patients.
Read the detailed description
Patients with advanced non-small cell lung cancer (NSCLC) who had treated with Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors（EGFR-TKI） and progressed slowly because of resistance are underwent with apatinib mesylate and continuous EGFR-TKI. The primary objective is the disease progression free survival of the patients. The secondary goals are overall survival, duration of response, objective response rates, disease control rates, quality of life scores and drug safety. Currently such patients are treated with EGFR-TKI continuously, but 3 months later, the disease will be progressed rapidly. This study will bring a new treatment that are more effective, less toxic and more convenient for NSCLC-patients with EGFR-TKI resistance.
- Being tested
- Apatinib（Tab. 500mg/d） combined with EGFR-TKI（as previously）
- Keywords
- Apatinib, EGFR-TKI resistance, slowly progress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apatinib（Tab. 500mg/d） combined with EGFR-TKI（as previously）Drug
Patients with advanced non-small cell lung cancer (NSCLC) who had treated with EGFR-TKI and progressed slowly because of resistance are underwent with apatinib mesylate and continuous EGFR-TKI.
| Study group | Role | What they receive |
|---|---|---|
| Apatinib combined with EGFR-TKI | Experimental | Apatinib（Tablet（Tab. ）500millgram（mg）/day（d）） combined with EGFR-TKI（as previously） Receives: Drug: Apatinib（Tab. 500mg/d） combined with EGFR-TKI（as previously） |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
the disease progression free survival of patients
Measured: 3 months
Secondary outcomes (2)
OS
overall survival
Measured: 8 months
ORR
objective response rates
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start1 Dec 2017
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cao，Hua, Shenzhen People's Hospital
- Investigators
- CAO HUA, MD, Principal investigator, Shenzhen People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03428022
- Sponsor's protocol ID
- AFLC
- Acronym
- AFLC
- Status last verified
- Apr 2019
- First submitted
- 15 Jan 2018
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apatinib Combined With Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors Used for the Advanced Slow-progressed Non Small Cell Lung Cancer Patients With EGFR-TKI Resistance
- ClinicalTrials.gov ID
- NCT03428022
- Acronym / sponsor ID
- AFLC / AFLC
- Keywords
- Apatinib, EGFR-TKI resistance, slowly progress
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Shenzhen People's HospitalUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 9 Feb 2018 (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.
Patients with advanced non-small cell lung cancer (NSCLC) who progress slowly after Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors（EGFR-TKI）resistance will be treated with Apatinib and EGFR-TKI. The primary objective is the disease progression free survival of the patients.
Detailed description
Patients with advanced non-small cell lung cancer (NSCLC) who had treated with Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors（EGFR-TKI） and progressed slowly because of resistance are underwent with apatinib mesylate and continuous EGFR-TKI. The primary objective is the disease progression free survival of the patients. The secondary goals are overall survival, duration of response, objective response rates, disease control rates, quality of life scores and drug safety. Currently such patients are treated with EGFR-TKI continuously, but 3 months later, the disease will be progressed rapidly. This study will bring a new treatment that are more effective, less toxic and more convenient for NSCLC-patients with EGFR-TKI resistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apatinib combined with EGFR-TKI | Experimental | Drug: Apatinib（Tab. 500mg/d） combined with EGFR-TKI（as previously）Apatinib（Tablet（Tab. ）500millgram（mg）/day（d）） combined with EGFR-TKI（as previously） |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pathologically confirmed advanced (stage IV) non-squamous, non-small cell lung cancer with measurable lesions
- Electronics Coordinating Grop（ECOG）score：0-2
- Expected survival over 3months
- Hemoglobin(HB)≥90 gram(g)/liter(L)；absolute neutrophil count(ANC)≥1.5×109/L；platelet(PLT)≥80×109/L；total-bilirubin（T-BIL）<1.5 upper limit of normal value（ULN）；alanine aminotransferase（ALT）and aspartate aminotransferase（AST）<2.5 ULN；Cr≤1.25ULN
Key exclusion criteria (6 listed)
- Brain metastases, meningococcal meningitis, patients with spinal cord compression with evidence of imaging (computed tomography（CT） / magnetic resonance imaging （MRI）, et cetera（etc.）);
- Uncontrolled hypertension (systolic blood pressure（BP）≥140 millimeter mercury column（mmHg） or diastolic BP ≥90 mmHg, despite optimal drug therapy);
- Hemorrhoid dysfunction (inernational standard ratio(INR)> 1.5 or prothrombin time (PT)> ULN + 4 seconds or activated partial thromboplastin(APTT)> 1.5 ULN) with bleeding tendency or undergoing thrombolytic or anticoagulant therapy;
- Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or the like;
- Patients underwent major surgery or severe traumatic injury, fracture or ulcer in 4 weeks before study;
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 |
|---|---|---|
| Apatinib（Tab. 500mg/d） combined with EGFR-TKI（as previously）Patients with advanced non-small cell lung cancer (NSCLC) who had treated with EGFR-TKI and progressed slowly because of resistance are underwent with apatinib mesylate and continuous EGFR-TKI. | Drug | Apatinib combined with EGFR-TKI |
Primary outcome
PFS
Time frame: 3 months
the disease progression free survival of patients
2 secondary outcomes
OS
Time frame: 8 months
ORR
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
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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.
CAO HUA, MD principal investigator
Shenzhen People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Apatinib（Tab. 500mg/d） combined with EGFR-TKI（as previously） in people with NSCLC and Apatinib, run by Shenzhen People's Hospital 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 4 inclusion and 6 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 4 Apr 2019. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 CAO HUA, MD (0086-755-22942406, caohua1206@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 3 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 4 Apr 2019.