Non-Small Cell Lung CancerPhase 3NCT02714010
EGFR-TKI Concurrent With/Without WBRT in Brain Metastasis From NSCLC
A Phase 3 study testing EGFR-TKI and whole brain radiotherapy in people with Non-Small Cell Lung Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
This is a multi-center phase III randomized controlled study, designing to access whether the efficacy of EGFR-TKI alone on patients with brain metastasis from non-small cell lung cancer (NSCLC) harboring EGFR mutant type is not inferior to EGFR-TKI concurrent with whole brain radiotherapy (WBRT), the primary end… 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?
- EGFR-TKI and whole brain radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 601 participants
- Where
- 1 siteChina
- Study dates
- Aug 2015to Dec 2022
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who was confirmed non-small cell lung cancer (NSCLC) by histology or cytology, harboring EGFR mutant type (19 and/or 21 exon mutation).
- Patients who was confirmed with asymptomatic, treatment naive brain metastasis (didn't receive any treatment after diagnosed with brain metastasis) by MRI, couldn't receive operation or stereotactic radiosurgery（SRS）.
- Appraisable disease, that is there must be at least one lesion with the longest diameter>10mm in brain (by brain MRI).
- Adult patients (18 to 75 years old). Eastern Cooperative Oncology Group（ECOG） performance status 0 to 2. Life expectancy of at least 12 weeks. Haemoglobin > 10g/dl, absolute neutrophil count (ANC) > 1.5 x 10^9/L, platelets > 100 x 10^9/L; total bilirubin < 1.5x upper limit of normal (ULN). Alanine aminotransferase（ALT） and aspartate aminotransferase（AST）< 1.5x ULN in the absence of liver metastases, or < 5x ULN in case of liver metastases. Creatinine clearance > 60ml/min (calculated according to Cockcroft-gault formula).
- Patients should be contraceptive during the period of the trial.
Who cannot join
- Patients who had received brain radiotherapy or EGFR-TKI before.
- Patients who can't receive WBRT.
- Uncontrolled intracranial hypertension after steroid or dehydration therapy.
- Patients who take phenytoin, Carbamazepine, Rifampicin, Barbital, or St John's Wort which will interfere with the metabolism of TKI.
- Patients with interstitial lung disease, significant ocular disease, or serious uncontrolled systematic disease.
- Patients who can't take oral tablets, with active peptic ulcer diseases.
- Pregnancy or breast-feeding women.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University of cancer center
Guangzhou, Guangdong, 510000
li-kun chen, doctor, 13798019964
About this study
Official title: Whole Brain Radiotherapy Concurrent With EGFR-TKI Versus EGFR-TKI Alone in the Treatment of Non-small Cell Lung Cancer Patients With Brain Metastasis
This is a multi-center phase III randomized controlled study, designing to access whether the efficacy of EGFR-TKI alone on patients with brain metastasis from non-small cell lung cancer (NSCLC) harboring EGFR mutant type is not inferior to EGFR-TKI concurrent with whole brain radiotherapy (WBRT), the primary end point is intracranial PFS (iPFS), while secondary outcomes included overall survival (OS), objective response rate (ORR), evaluation of cognitive function, quality of life (QoL) and adverse events.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- EGFR-TKI, whole brain radiotherapy
- Keywords
- EGFR-TKI, whole brain radiotherapy, brain metastasis, non-small cell lung cancer
- 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.
EGFR-TKIDrug
Also called Gefitinib/Tarceva/Icotinib
Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid
whole brain radiotherapyRadiation
Also called WBRT
30Gy/10F
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Patients take EGFR-TKI alone till tumor progression Receives: Drug: EGFR-TKI |
| Arm 2 | Active comparator | Patients take EGFR-TKI concurrent with whole brain radiotherapy (WBRT) till tumor progression, WBRT started within the first week of taking TKI Receives: Drug: EGFR-TKI; Radiation: whole brain radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
intracranial PFS (iPFS)
Compare intracranial PFS (iPFS) of two arms
Measured: up to 41 months
Secondary outcomes (2)
overall survival (OS)
Measured: up to 77 months
objective response rate (ORR)
Measured: up to 41 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study startAug 2015
- 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.
- More trials run by Sun Yat-sen UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 601 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li-kun Chen, Sun Yat-sen University
- Investigators
- li-kun Chen, Principal investigator, associate chief physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02714010
- Sponsor's protocol ID
- GASTO1014
- Status last verified
- Oct 2017
- First submitted
- 29 Nov 2015
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Brain Radiotherapy Concurrent With EGFR-TKI Versus EGFR-TKI Alone in the Treatment of Non-small Cell Lung Cancer Patients With Brain Metastasis
- ClinicalTrials.gov ID
- NCT02714010
- Acronym / sponsor ID
- GASTO1014
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- EGFR-TKI, whole brain radiotherapy, brain metastasis, non-small cell lung cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 601 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 21 Mar 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 is a multi-center phase III randomized controlled study, designing to access whether the efficacy of EGFR-TKI alone on patients with brain metastasis from non-small cell lung cancer (NSCLC) harboring EGFR mutant type is not inferior to EGFR-TKI concurrent with whole brain radiotherapy (WBRT), the primary end point is intracranial PFS (iPFS), while secondary outcomes included overall survival (OS), objective response rate (ORR), evaluation of cognitive function, quality of life (QoL) and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: EGFR-TKIPatients take EGFR-TKI alone till tumor progression |
| Arm 2 | Active comparator | Drug: EGFR-TKI, Radiation: whole brain radiotherapyPatients take EGFR-TKI concurrent with whole brain radiotherapy (WBRT) till tumor progression, WBRT started within the first week of taking TKI |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who was confirmed non-small cell lung cancer (NSCLC) by histology or cytology, harboring EGFR mutant type (19 and/or 21 exon mutation).
- Patients who was confirmed with asymptomatic, treatment naive brain metastasis (didn't receive any treatment after diagnosed with brain metastasis) by MRI, couldn't receive operation or stereotactic radiosurgery（SRS）.
- Appraisable disease, that is there must be at least one lesion with the longest diameter>10mm in brain (by brain MRI).
- Adult patients (18 to 75 years old). Eastern Cooperative Oncology Group（ECOG） performance status 0 to 2. Life expectancy of at least 12 weeks. Haemoglobin > 10g/dl, absolute neutrophil count (ANC) > 1.5 x 10^9/L, platelets > 100 x 10^9/L; total bilirubin < 1.5x upper limit of normal (ULN). Alanine aminotransferase（ALT） and aspartate aminotransferase（AST）< 1.5x ULN in the absence of liver metastases, or < 5x ULN in case of liver metastases. Creatinine clearance > 60ml/min (calculated according to Cockcroft-gault formula).
- Patients should be contraceptive during the period of the trial.
Key exclusion criteria (7 listed)
- Patients who had received brain radiotherapy or EGFR-TKI before.
- Patients who can't receive WBRT.
- Uncontrolled intracranial hypertension after steroid or dehydration therapy.
- Patients who take phenytoin, Carbamazepine, Rifampicin, Barbital, or St John's Wort which will interfere with the metabolism of TKI.
- Patients with interstitial lung disease, significant ocular disease, or serious uncontrolled systematic disease.
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 |
|---|---|---|
| EGFR-TKIAlso: Gefitinib/Tarceva/IcotinibGefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid | Drug | Arm 1, Arm 2 |
| whole brain radiotherapyAlso: WBRT30Gy/10F | Radiation | Arm 2 |
Primary outcome
intracranial PFS (iPFS)
Time frame: up to 41 months
Compare intracranial PFS (iPFS) of two arms
2 secondary outcomes
overall survival (OS)
Time frame: up to 77 months
objective response rate (ORR)
Time frame: up to 41 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
Related trials for Non-Small Cell Lung Cancer
RecruitingPhase 3
A Study to Learn About the Study Medicine Called PF-08046054/SGN-PDL1V Versus Docetaxel in Adult Participants With Previously-Treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC)
Non-small Cell Carcinoma, Non-Small Cell Lung Cancer Metastatic
RecruitingObservational study
Real-World Outcomes of Sevabertinib in HER2-Mutant Advanced NSCLC: A Bidirectional Cohort Study
HER2-mutant Advanced Non-Small Cell Lung Cancer
Active, not recruitingPhase 2
CAN-2409 Plus Prodrug With Standard of Care Immune Checkpoint Inhibitor for Stage III/IV NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 2
Hotspot Stereotactic Ablative Radiotherapy Versus Traditional Stereotactic Ablative Radiotherapy for the Treatment of Early-Stage Non-Small Cell Lung Cancer
Early Stage Lung Non-Small Cell Carcinoma, Stage I Lung Cancer AJCC v8
RecruitingObservational study
Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols
Multiple Myeloma, Lymphoma, Non-Hodgkin
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-kun Chen principal investigator
associate chief physician
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 EGFR-TKI and whole brain radiotherapy in people with Non-Small Cell Lung Cancer, run by Sun Yat-sen University 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 5 inclusion and 7 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 Oct 2017. 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 li-kun Chen (13798019964, chenlk@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intracranial PFS (iPFS) (time frame: up to 41 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 Oct 2017; AzTrials last refreshed its copy on 6 Nov 2026.