Non-small Cell Lung CancerPhase 2NCT02726568
High Dose Icotinib With Sequential SRS For NSCLC Patients Harboring EGFR Mutation With Brain Metastases
A Phase 2 study testing Icotinib and SRS in people with Non-small Cell Lung Cancer and Brain Metastases, run by Betta Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
This trail is designed to assess the efficacy and safety of high dose Iconitib combined with SRS for NSCLC patients harboring EGFR mutation with brain metastases. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer, Brain Metastases
- What is being tested?
- Icotinib and SRS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytological confirmation of non-small cell lung cancer (NSCLC);
- Diagnosis of brain metastases on a Gadolinium-enhanced MRI.
- Less than 10 sites of intracranial metastases, or the longest diameter of the intracranial lesion is less than 4cm.
- Positive EGFR mutation（Ex19del or 21L858R）.
- Life expectancy ≥3months.
- Have one or more measurable encephalic lesions according to RECIST.
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- The patient has not received radiotherapy for the head or extracranial target lesions before.
- Adequate hematological function: Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥100 x 109/L.
- Adequate renal function: Serum creatinine ≤1.5 x ULN, or ≥ 50 ml/min.
- Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) and Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases.
- Female subjects should not be pregnant.
- All human subjects should able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
- Written informed consent provided.
Who cannot join
- Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.
- CSF or MRI findings consistent with metastases of spinal cord, meninges or meningeal.
- Allergic to Icotinib.
- Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease.
- Pregnancy or breast-feeding women.
- Participate in the other anti-tumor clinical trials in 4 weeks.
- have quit from the trail before.
- Any other serious underlying medical, psychological and other condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital
Chengdu, Sichuan, 610041
YOU LU, M.D.
YOU LU, M.D.
About this study
Official title: A Phase II Study to Determine the Efficacy and Safety of High Dose Icotinib Combined With Stereotatic Radiosurgery for NSCLC Patients Harboring EGFR Mutation With Brain Metastases
This trail is designed to assess the efficacy and safety of high dose Iconitib combined with SRS for NSCLC patients harboring EGFR mutation with brain metastases.
Read the detailed description
The long-term control of brain metastases becomes a clinical challenge. Whole brain radiotherapy, the standard treatment for patients with multiple brain metastases, can only bring a modest survival improvement around 3-6 months. EGFR-TKIs like icotinib with its proven activity in non-small cell lung cancer may provide clinical benefits to brain metastases patients.
- Conditions
- Non-small Cell Lung Cancer, Brain Metastases
- Being tested
- Icotinib, SRS
- Keywords
- EGFR-TKI, NSCLC, Icotinib, SRS, radiotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IcotinibDrug
375 mg Tid (1125 mg per day) until intracranial PD.
SRSRadiation
If intracranial PD, then the subjects get stereotatic radiosurgery （30Gy/3f) combined with Icotinib 375mg Tid.
| Study group | Role | What they receive |
|---|---|---|
| Icotinib 375mg Tid | Experimental | The human subject gets icotinib 375mg, Tid until intracranial PD or intolerable toxicity reaction. Receives: Drug: Icotinib; Radiation: SRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
intracranial progression-free survival
Measured: from date of randomization until the date of first documented intracranial progression, assessed up to 12 months.
Secondary outcomes (5)
progress-free survival
Measured: from date of randomization until the date of extracranial progression, assessed up to 18 months.
overall survival
Measured: from date of randomization until the date of death, assessed up to 36 months.
objective response rate
Measured: from date of randomization until the date of progression, assessed up to 12 months.
disease control rate
Measured: from date of randomization until the date of progression, assessed up to 18 months.
Quality of life measured by FACT-L/LCS 4.0 and FACT-Br
Measured: from date of randomization until the date of death from any cause, assessed up to 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2021 (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 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- YOU LU, M.D., Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726568
- Sponsor's protocol ID
- BD-IC-IV-65
- Status last verified
- Feb 2019
- First submitted
- 29 Mar 2016
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Determine the Efficacy and Safety of High Dose Icotinib Combined With Stereotatic Radiosurgery for NSCLC Patients Harboring EGFR Mutation With Brain Metastases
- ClinicalTrials.gov ID
- NCT02726568
- Acronym / sponsor ID
- BD-IC-IV-65
- Conditions
- Non-small Cell Lung Cancer, Brain Metastases
- Keywords
- EGFR-TKI, NSCLC, Icotinib, SRS, radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 1 Apr 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.
This trail is designed to assess the efficacy and safety of high dose Iconitib combined with SRS for NSCLC patients harboring EGFR mutation with brain metastases.
Detailed description
The long-term control of brain metastases becomes a clinical challenge. Whole brain radiotherapy, the standard treatment for patients with multiple brain metastases, can only bring a modest survival improvement around 3-6 months. EGFR-TKIs like icotinib with its proven activity in non-small cell lung cancer may provide clinical benefits to brain metastases patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Icotinib 375mg Tid | Experimental | Drug: Icotinib, Radiation: SRSThe human subject gets icotinib 375mg, Tid until intracranial PD or intolerable toxicity reaction. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histological or cytological confirmation of non-small cell lung cancer (NSCLC);
- Diagnosis of brain metastases on a Gadolinium-enhanced MRI.
- Less than 10 sites of intracranial metastases, or the longest diameter of the intracranial lesion is less than 4cm.
- Positive EGFR mutation（Ex19del or 21L858R）.
- Life expectancy ≥3months.
Key exclusion criteria (8 listed)
- Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.
- CSF or MRI findings consistent with metastases of spinal cord, meninges or meningeal.
- Allergic to Icotinib.
- Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease.
- Pregnancy or breast-feeding women.
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 |
|---|---|---|
| Icotinib375 mg Tid (1125 mg per day) until intracranial PD. | Drug | Icotinib 375mg Tid |
| SRSIf intracranial PD, then the subjects get stereotatic radiosurgery （30Gy/3f) combined with Icotinib 375mg Tid. | Radiation | Icotinib 375mg Tid |
Primary outcome
intracranial progression-free survival
Time frame: from date of randomization until the date of first documented intracranial progression, assessed up to 12 months.
5 secondary outcomes
progress-free survival
Time frame: from date of randomization until the date of extracranial progression, assessed up to 18 months.
overall survival
Time frame: from date of randomization until the date of death, assessed up to 36 months.
objective response rate
Time frame: from date of randomization until the date of progression, assessed up to 12 months.
disease control rate
Time frame: from date of randomization until the date of progression, assessed up to 18 months.
Quality of life measured by FACT-L/LCS 4.0 and FACT-Br
Time frame: from date of randomization until the date of death from any cause, assessed up to 36 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- Individual participant dataSharing planned: Undecided
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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.
YOU LU, M.D. principal investigator
West China Hospital
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 Icotinib and SRS in people with Non-small Cell Lung Cancer and Brain Metastases, run by Betta Pharmaceuticals 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 13 inclusion and 8 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 19 Feb 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 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 YOU LU, M.D. (0086-28-85423571, radyoulu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intracranial progression-free survival (time frame: from date of randomization until the date of first documented intracranial progression, assessed up to 12 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 19 Feb 2019; AzTrials last refreshed its copy on 31 Oct 2026.