Non-small-cell Lung CancerPhase 4NCT01926171
Icotinib With Whole Brain Radiation Therapy in NSCLC Patients With Brain Metastases
A Phase 4 study testing Icotinib plus WBRT in people with Non-small-cell Lung Cancer, run by Betta Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of icotinib in combination with whole brain radiotherapy for NSCLC patients with brain metastases. The primary endpoint is objective response rate of intracranial lesions. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small-cell Lung Cancer
- What is being tested?
- Icotinib plus WBRT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Jun 2013to Dec 2016
- Phase
- Phase 4
- 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 non-systematic brain metastases on a Gadolinium-enhanced MRI. More than 2 sites of intracranial metastases, or the longest diameter of the intracranial lesion is more than 3cm.
- No other metastases except for brain metastases.
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.
Trial locations and contacts
1 site in 1 country.
Wei Zhu, MD contact
China1 site, 1 recruiting
- Recruiting
Baotou Central Hospital
Baotou, Inner Mongolia
Wei Zhu, MD
Wei Zhu, MD
About this study
Official title: A Single Center, Open Label, Multicenter Study to Determine the Safety and Efficacy of Icotinib in Combination With Whole Brain Radiation Therapy For NSCLC Patients With Brain Metastases
The purpose of this study is to evaluate the safety and efficacy of icotinib in combination with whole brain radiotherapy for NSCLC patients with brain metastases. The primary endpoint is objective response rate of intracranial lesions.
Read the detailed description
Non-small cell lung cancer (NSCLC) is one of the malignant tumors with the highest incidence of brain metastases. Patients with multiple brain metastasis showed poor prognosis and displayed an untreated median survival of only 3-6 months, and most patients died due to the progression of brain metastases. This study is designed to evaluate the safety and efficacy of icotinib combined with whole brain radiotherapy for NSCLC patients with brain metastases. The primary endpoint is intracranial objective response rate .
- Conditions
- Non-small-cell Lung Cancer
- Being tested
- Icotinib plus WBRT
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Icotinib plus WBRTDrug
Also called Commana, BPI-2009
Standard whole brain radiotherapy is given with 4000cGY/20 times, plus icotinib, which was administered orally three times per day.
| Study group | Role | What they receive |
|---|---|---|
| Icotinib plus WBRT | Experimental | Standard whole brain radiotherapy is given with 4000cGY/20 times, plus concurrent icotinib, which was administered orally three times per day. Receives: Drug: Icotinib plus WBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate of intracranial lesions
Number of participants with an objective response. An objective response (OR) was defined as a patient having a best overall response of either complete response (CR) or partial response (PR) according to RECIST, confirmed at least 28 days following the date of the initial response.
Measured: 8 weeks
Secondary outcomes (3)
Objective response rate of extracranial lesions
Number of participants with an objective response of extracranial lesions. An objective response (OR) was defined as a patient having a best overall response of either complete response (CR) or partial response (PR) according to RECIST, confirmed at least 28 days following the date of the initial response.
Measured: 8 weeks
Progression-free survival of intracranial lesions
All cause progress or mortality
Measured: 3-6 months
Safety and tolerability
All cause adverse events (AEs) and serious adverse events (SAEs)
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2016 (estimated)
- Study completionDec 2016 (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.
- More trials run by Betta Pharmaceuticals 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wei Zhu, MD, Principal investigator, Baotou Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926171
- Sponsor's protocol ID
- BD-IV-49
- Status last verified
- Jul 2015
- First submitted
- 16 Aug 2013
- Last updated
- 15 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open Label, Multicenter Study to Determine the Safety and Efficacy of Icotinib in Combination With Whole Brain Radiation Therapy For NSCLC Patients With Brain Metastases
- ClinicalTrials.gov ID
- NCT01926171
- Acronym / sponsor ID
- BD-IV-49
- Conditions
- Non-small-cell Lung Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 20 Aug 2013 (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 safety and efficacy of icotinib in combination with whole brain radiotherapy for NSCLC patients with brain metastases. The primary endpoint is objective response rate of intracranial lesions.
Detailed description
Non-small cell lung cancer (NSCLC) is one of the malignant tumors with the highest incidence of brain metastases. Patients with multiple brain metastasis showed poor prognosis and displayed an untreated median survival of only 3-6 months, and most patients died due to the progression of brain metastases. This study is designed to evaluate the safety and efficacy of icotinib combined with whole brain radiotherapy for NSCLC patients with brain metastases. The primary endpoint is intracranial objective response rate .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Icotinib plus WBRT | Experimental | Drug: Icotinib plus WBRTStandard whole brain radiotherapy is given with 4000cGY/20 times, plus concurrent icotinib, which was administered orally three times per day. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histological or cytological confirmation of non-small-cell lung cancer (NSCLC).
- Diagnosis of non-systematic brain metastases on a Gadolinium-enhanced MRI. More than 2 sites of intracranial metastases, or the longest diameter of the intracranial lesion is more than 3cm.
- No other metastases except for brain metastases.
Key exclusion criteria (2 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.
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 |
|---|---|---|
| Icotinib plus WBRTAlso: Commana, BPI-2009Standard whole brain radiotherapy is given with 4000cGY/20 times, plus icotinib, which was administered orally three times per day. | Drug | Icotinib plus WBRT |
Primary outcome
Objective response rate of intracranial lesions
Time frame: 8 weeks
Number of participants with an objective response. An objective response (OR) was defined as a patient having a best overall response of either complete response (CR) or partial response (PR) according to RECIST, confirmed at least 28 days following the date of the initial response.
3 secondary outcomes
Objective response rate of extracranial lesions
Time frame: 8 weeks
Progression-free survival of intracranial lesions
Time frame: 3-6 months
Safety and tolerability
Time frame: 6-12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2015.
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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.
Wei Zhu, MD contact
Wei Zhu, MD principal investigator
Baotou Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Icotinib plus WBRT in people with Non-small-cell Lung Cancer, 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 3 inclusion and 2 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 15 Jul 2015. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Wei Zhu, MD (86-18686111667), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate of intracranial lesions (time frame: 8 weeks). 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 15 Jul 2015.