Non-Small Cell Lung CancerPhase 2NCT03754530
Icotinib Combined With Radiation Therapy For NSCLC Patients With Brain Metastases and EGFR Mutation
A Phase 2 study testing Icotinib and WBRT or SRS in people with Non-Small Cell Lung Cancer and Brain Metastases, run by Betta Pharmaceuticals Co., Ltd..
Trial summary
The purpose of this study is to evaluate the efficacy of icotinib in combination with radiotherapy for NSCLC patients with brain metastases. The primary endpoint is PFS 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, Brain Metastases
- What is being tested?
- Icotinib and WBRT or SRS
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2018to 1 Dec 2021
- 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) with brain metastases
- Histological or cytological confirmation of EGRF positive sensitive mutation
- Diagnosis of brain metastases on a Gadolinium-enhanced MRI
Who cannot join
- Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux
- Previous usage of radiation with brain
- CSF or MRI findings consistent with metastases of spinal cord, meninges or meningeal.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multi-center, Open Label Study to Determine the Timelines and Effeciency of Icotinib in Combination With Radiation Therapy For NSCLC Patients With Brain Metastases and EGFR Mutation
The purpose of this study is to evaluate the efficacy of icotinib in combination with radiotherapy for NSCLC patients with brain metastases. The primary endpoint is PFS 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 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. Some research showed that Icotinib alone can improve the efficiency of NSCLC with brain metastases, but there is still unknow about the result about combination with EGFR-TKI and radiotherapy. This study is designed to evaluate the efficacy of icotinib combined with radiotherapy for NSCLC patients with brain metastases.
- Conditions
- Non-Small Cell Lung Cancer, Brain Metastases
- Being tested
- Icotinib, WBRT or SRS
- Keywords
- NSCLC brain metastases
- 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
Also called WBRT or SRS
orally three times per day
WBRT or SRSRadiation
Also called Icotinib
>3 with WBRT;<=3 with SRS
| Study group | Role | What they receive |
|---|---|---|
| Icotinib | Experimental | icotinib is administered orally three times per day. Until emerge the progression of the intracranial disease, then is given radiotherapy(>3 with WBRT or <=3 with SRS) after PD Receives: Drug: Icotinib |
| Icotinib plus radiation therapy | Experimental | Standard whole brain radiotherapy (WBRT) is given with 30GY/10 times(>3), or SRS(<=3) plus concurrent icotinib, which was administered orally three times per day. Until the disease progresses. Receives: Drug: Icotinib; Radiation: WBRT or SRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival of intracranial lesions
Number of participants with progress of intracranial lesions
Measured: 10 months
Secondary outcomes (2)
Progression-free survival
Number of participants with progress of any places in body
Measured: 8 months
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start1 Dec 2018 (estimated)
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Dec 2021 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li jiancheng, Study director, Fujian oncology hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03754530
- Sponsor's protocol ID
- 2018-007-02
- Status last verified
- Nov 2018
- First submitted
- 31 Oct 2018
- Last updated
- 27 Nov 2018
- 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 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open Label Study to Determine the Timelines and Effeciency of Icotinib in Combination With Radiation Therapy For NSCLC Patients With Brain Metastases and EGFR Mutation
- ClinicalTrials.gov ID
- NCT03754530
- Acronym / sponsor ID
- 2018-007-02
- Conditions
- Non-Small Cell Lung Cancer, Brain Metastases
- Keywords
- NSCLC brain metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 27 Nov 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.
The purpose of this study is to evaluate the efficacy of icotinib in combination with radiotherapy for NSCLC patients with brain metastases. The primary endpoint is PFS 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 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. Some research showed that Icotinib alone can improve the efficiency of NSCLC with brain metastases, but there is still unknow about the result about combination with EGFR-TKI and radiotherapy. This study is designed to evaluate the efficacy of icotinib combined with radiotherapy for NSCLC patients with brain metastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Icotinib | Experimental | Drug: Icotinibicotinib is administered orally three times per day. Until emerge the progression of the intracranial disease, then is given radiotherapy(>3 with WBRT or <=3 with SRS) after PD |
| Icotinib plus radiation therapy | Experimental | Drug: Icotinib, Radiation: WBRT or SRSStandard whole brain radiotherapy (WBRT) is given with 30GY/10 times(>3), or SRS(<=3) plus concurrent icotinib, which was administered orally three times per day. Until the disease progresses. |
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) with brain metastases
- Histological or cytological confirmation of EGRF positive sensitive mutation
- Diagnosis of brain metastases on a Gadolinium-enhanced MRI
Key exclusion criteria (3 listed)
- Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux
- Previous usage of radiation with brain
- 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 |
|---|---|---|
| IcotinibAlso: WBRT or SRSorally three times per day | Drug | Icotinib, Icotinib plus radiation therapy |
| WBRT or SRSAlso: Icotinib>3 with WBRT;<=3 with SRS | Radiation | Icotinib plus radiation therapy |
Primary outcome
Progression-free survival of intracranial lesions
Time frame: 10 months
Number of participants with progress of intracranial lesions
2 secondary outcomes
Progression-free survival
Time frame: 8 months
Objective response rate of intracranial lesions
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
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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.
Li jiancheng study director
Fujian oncology hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Icotinib and WBRT or SRS in people with Non-Small Cell Lung Cancer and Brain Metastases, run by Betta Pharmaceuticals Co., Ltd..
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 3 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 27 Nov 2018. 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 Li jiancheng (86+13906900190 ext. 8613906900190, jianchengli6@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival of intracranial lesions (time frame: 10 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 27 Nov 2018.