Advanced EGFR-TKI-resistant Non-Small Cell Lung CancerPhase 2NCT02815007
Chidamide With EGFR-TKI for Advanced EGFR-TKI-resistant Non-Small Cell Lung Cancer
A Phase 2 study testing Chidamide with EGFR-TKI in people with Advanced EGFR-TKI-resistant Non-Small Cell Lung Cancer, run by Yuankai Shi.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Chidamide with EGFR-TKI for Advanced EGFR-TKI-resistant Non-Small Cell Lung Cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced EGFR-TKI-resistant Non-Small Cell Lung Cancer
- What is being tested?
- Chidamide with EGFR-TKI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Jun 2018
- 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
- Stage IIIB/IV non-small cell lung carcinoma with EGFR 19/21 point mutation, verified by histology or cytology.
- Achieved remission (CR or PR) over previous EGFR-TKI treatment; or achieved stable disease (SD) ≥ 6 months over previous EGFR-TKI treatment; disease progression emerged during the following EGFR-TKI treatment (within the past 30 days); no other treatment employed after the withdrawn of EGFR-TKI.
- Age ≥18 years, male or female;
- Has at least 1 measurable focus according to RECIST criteria 1.1, which has not been treated by radiotherapy.
- General condition should be ECOG 0-2, expected survival ≥ 3 months.
- Organ functions should fit the following:
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- Bone marrow: absolute neutrophil count ≥1.5 × 109/L, platelet ≥100 × 109/L, Hb ≥ 90g/L; Liver: Total bilirubin ≤ 1.5 times of the normal maximum, ALT and AST≤ 2.5 times of the normal maximum. (ALT/AST≤ 5 times of the normal maximum for patients with infiltrative liver disease) Coagulation: INR or PT ˂ 1.5 folds of the normal maximum; Serum creatinine ˂ 1.5 folds of the normal maximum; creatinine clearance rate ≥50ml/min (calculated by Cockroft-Gault10 formula), for underweight patients, or whose results differ largely from the two formula, other methods for creatinine clearance rate calculation should be employed, like the EDTA method, inulin clearance method or 24 hour urine analysis.
- For patients with metastatic brain disease, their symptoms should be well controlled by regional therapy (surgery or radiotherapy), and no need for hormone maintenance therapy.
- For fertile women, urine or blood pregnancy test should be negative within 7 days prior to the treatment, all patients (male and female) should have contraceptive measures during the whole treatment period and 4 weeks after the treatment; willing to sign the written consent and be enrolled in the trial, and adhere to the treatment and follow up protocol.
Who cannot join
- Non-small cell lung carcinoma that has not been treated by EGFR-TKI.
- Patients that have taken other un-authorized medicine or medicine from other trials within 30 days before the 1st day of this trial.
- Patients with active hemorrhage or new thrombotic disorders, or those who is taking anti-coagulation drugs or those with hemorrhagic tendencies.
- History of surgery of visceral organs within 6 weeks before the trial.
- Patients' organ conditions:
- Metastatic brain/ meningeal disorders (except for those whose symptoms are well controlled by regional therapy, and no need for hormone maintenance therapy).
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- Patients with history of mesenchymal lung disease, drug-induced mesenchymal disease, hormone-required radiation pneumonia, idiopathic lung fibrosis in baseline CT scan, uncontrolled massive pleural effusion or pericardial effusion.
- Patients with evidence of severe or uncontrolled systemic disease (like unstable or non-compensated respiratory/cardiac/hepatic/renal disease), according to the judgment of the researchers.
- Any unstable systemic disease (including ˃ CTCAE 2 active clinical infection, level IV hypertension, unstable angina pectoris, congestive heart failure, QT interval ˃450ms, HIV infection, metabolic liver or kidney disease); History of any malignant tumor within 5 years prior to the trial. Definitive history of neural or mental disorders, including seizure or dementia.
- Patients with xenogenic organ transplantation, patients had severe injury or massive surgery 4 weeks prior to the 1st dosage admission of medicine in the trial.
- Women during pregnancy or lactation.
- Allergic constitution, like those who are allergic to ≥2 foods or drugs, or allergic to the components of the medicine used in the trial;
- Any condition that impairs the patients' ability to swallow, and any condition that impairs drug absorption or drug kinetic parameters, including any kind of gastrointestinal resection or surgery;
- Patients with drug abuse, or any medical, psychological, social conditions that may impair trial process or the evaluation of the results of the trial;
- Any condition that may influence the safety or compliance of the patients.
- Patients that the researchers think are not appropriate for regimen in the trial.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Chidamide With EGFR-TKI for Advanced EGFR-TKI-resistant Non-Small Cell Lung Cancer: An Open-label, Single-armed Phase II Trial
The purpose of this study is to evaluate the efficacy and safety of Chidamide with EGFR-TKI for Advanced EGFR-TKI-resistant Non-Small Cell Lung Cancer
Read the detailed description
(1)The efficacy of the regimen is evaluated by objective remission rate, disease control rate, progress free survival, duration of remission, overall survival, time to progression.
Safety is monitored by vital signs, blood routine test, liver function, kidney function and electrolytes level, ECG, and cardiac ultrasonography.
All the data is documented by CRF form, and carefully preserved.
- Being tested
- Chidamide with EGFR-TKI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chidamide with EGFR-TKIDrug
Also called Epidaza，HBI-8000
Chidamide and EGFR-TKI, dosage described in arm description.
| Study group | Role | What they receive |
|---|---|---|
| Chidamide with EGFR-TKI | Experimental | Chidamide: Per Os, 30mg (5mg*6), twice a week, time interval between 2 medications should be ≥3 days, medicine taken 30 minutes after breakfast.
EGFR-TKI:
Taken according to the instruction book Receives: Drug: Chidamide with EGFR-TKI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Remission Rate
Measured: through study completion, an average of 15 months
Disease Control Rate
Measured: through study completion, an average of 15 months
Secondary outcomes (11)
Progression free survival
Measured: through study completion, an average of 15 months
Duration of Remission
Measured: through study completion, an average of 15 months
Overall Survival
Measured: through study completion, an average of 15 months
Time to Progression
Measured: through study completion, an average of 15 months
Vital signs
Measured: Every 2 weeks for the first 6 months, every month for the remaining 6 months
Serum alanine aminotransferase level
Measured: Every 2 weeks for the first 6 months, every month for the remaining 6 months
Serum aspartate transaminase level
Measured: Every 2 weeks for the first 6 months, every month for the remaining 6 months
Serum creatinine level
Measured: Every 2 weeks for the first 6 months, every month for the remaining 6 months
Serum urea nitrogen level
Measured: Every 2 weeks for the first 6 months, every month for the remaining 6 months
Serum electrolytes level
Measured: Every 2 weeks for the first 6 months, every month for the remaining 6 months
Serum brain natriuretic peptide (BNP) level
Measured: Every 2 weeks for the first 6 months, every month for the remaining 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionMar 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced EGFR-TKI-resistant Non-Small Cell Lung CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuankai Shi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yuankai Shi, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Yuankai Shi, Doctor, Principal investigator, Cancer institute and hospital, Chinese academy of medical sciencees
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02815007
- Sponsor's protocol ID
- CancerIHCAMS
- Status last verified
- Jun 2016
- First submitted
- 19 Jun 2016
- Last updated
- 28 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chidamide With EGFR-TKI for Advanced EGFR-TKI-resistant Non-Small Cell Lung Cancer: An Open-label, Single-armed Phase II Trial
- ClinicalTrials.gov ID
- NCT02815007
- Acronym / sponsor ID
- CancerIHCAMS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Yuankai ShiUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 28 Jun 2016 (estimated)
- 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 purpose of this study is to evaluate the efficacy and safety of Chidamide with EGFR-TKI for Advanced EGFR-TKI-resistant Non-Small Cell Lung Cancer
Detailed description
(1)The efficacy of the regimen is evaluated by objective remission rate, disease control rate, progress free survival, duration of remission, overall survival, time to progression.
Safety is monitored by vital signs, blood routine test, liver function, kidney function and electrolytes level, ECG, and cardiac ultrasonography.
All the data is documented by CRF form, and carefully preserved.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chidamide with EGFR-TKI | Experimental | Drug: Chidamide with EGFR-TKIChidamide: Per Os, 30mg (5mg*6), twice a week, time interval between 2 medications should be ≥3 days, medicine taken 30 minutes after breakfast. EGFR-TKI: Taken according to the instruction book |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Stage IIIB/IV non-small cell lung carcinoma with EGFR 19/21 point mutation, verified by histology or cytology.
- Achieved remission (CR or PR) over previous EGFR-TKI treatment; or achieved stable disease (SD) ≥ 6 months over previous EGFR-TKI treatment; disease progression emerged during the following EGFR-TKI treatment (within the past 30 days); no other treatment employed after the withdrawn of EGFR-TKI.
- Age ≥18 years, male or female;
- Has at least 1 measurable focus according to RECIST criteria 1.1, which has not been treated by radiotherapy.
- General condition should be ECOG 0-2, expected survival ≥ 3 months.
Key exclusion criteria (16 listed)
- Non-small cell lung carcinoma that has not been treated by EGFR-TKI.
- Patients that have taken other un-authorized medicine or medicine from other trials within 30 days before the 1st day of this trial.
- Patients with active hemorrhage or new thrombotic disorders, or those who is taking anti-coagulation drugs or those with hemorrhagic tendencies.
- History of surgery of visceral organs within 6 weeks before the trial.
- Patients' organ conditions:
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 |
|---|---|---|
| Chidamide with EGFR-TKIAlso: Epidaza，HBI-8000Chidamide and EGFR-TKI, dosage described in arm description. | Drug | Chidamide with EGFR-TKI |
Primary outcome
Objective Remission Rate
Time frame: through study completion, an average of 15 months
Disease Control Rate
Time frame: through study completion, an average of 15 months
11 secondary outcomes
Progression free survival
Time frame: through study completion, an average of 15 months
Duration of Remission
Time frame: through study completion, an average of 15 months
Overall Survival
Time frame: through study completion, an average of 15 months
Time to Progression
Time frame: through study completion, an average of 15 months
Vital signs
Time frame: Every 2 weeks for the first 6 months, every month for the remaining 6 months
Serum alanine aminotransferase level
Time frame: Every 2 weeks for the first 6 months, every month for the remaining 6 months
Serum aspartate transaminase level
Time frame: Every 2 weeks for the first 6 months, every month for the remaining 6 months
Serum creatinine level
Time frame: Every 2 weeks for the first 6 months, every month for the remaining 6 months
Serum urea nitrogen level
Time frame: Every 2 weeks for the first 6 months, every month for the remaining 6 months
Serum electrolytes level
Time frame: Every 2 weeks for the first 6 months, every month for the remaining 6 months
Serum brain natriuretic peptide (BNP) level
Time frame: Every 2 weeks for the first 6 months, every month for the remaining 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2016.
- Individual participant dataSharing planned: Undecided
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Phase 1/2 Study of Silevertinib (BDTX-1535) in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations
Non-Small Cell Lung Cancer, Advanced Non-Small Cell Squamous 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.
Yuankai Shi, Doctor principal investigator
Cancer institute and hospital, Chinese academy of medical sciencees
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chidamide with EGFR-TKI in people with Advanced EGFR-TKI-resistant Non-Small Cell Lung Cancer, run by Yuankai Shi.
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 16 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 28 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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 Yuankai Shi, Doctor (86-015821531560, drshiyuankai@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Remission Rate (time frame: through study completion, an average of 15 months). The study lists 2 primary outcomes in all. 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 28 Jun 2016; AzTrials last refreshed its copy on 7 Nov 2026.