Non Small Cell Lung CancerPhase 3SMARTNCT04058704
A Study to Determine the Efficiency For Brain Metastasis NSCLC Patients Treated With Icotinib Alone or Combined With Radiation Therapy
A Phase 3 study testing Icotinib and SRS/WBRT/HA-WBRT/SMART in people with Non Small Cell Lung Cancer and Brain Metastases, run by Betta Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy of icotinib alone or in combination with radiation therapy for NSCLC patients harboring EGFR mutation with brain metastases. The primary endpoint is overall survival . 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/WBRT/HA-WBRT/SMART
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 296 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2018to 31 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
- Histological or cytological confirmation of non-small-cell lung cancer (NSCLC)
- Positive EGFR mutation（Ex19del or 21L858R）
- Primary diagnosis of brain metastases
- Have one or more measurable encephalic lesions according to RECIST
- Extracranial transfer organ≤3
- ECGO:0-2
Show all 12Show fewer
- 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 : gefitinib, erlotinib, icotinib，or any other TKI
- 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
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
Chen Ming, chenming@zjcc.org.cn
Wang Jin, wangjin@zjcc.org.cn
About this study
Official title: A Multi-center, Prospective Study to Determine the Efficiency of Icotinib Combined With Radiation Therapy Early Intervention or Late Intervention For NSCLC Patients With Brain Metastases and EGFR(Epidermal Growth Factor Receptor) Mutation
The purpose of this study is to evaluate the efficacy of icotinib alone or in combination with radiation therapy for NSCLC patients harboring EGFR mutation with brain metastases. The primary endpoint is overall survival .
Read the detailed description
Non-small cell lung cancer (NSCLC) is one of the malignant tumors with the highest incidence of brain metastases, and most patients died due to the progression of brain metastases. Some research show that icotinib combined with radiation therapy can improve the efficiency of NSCLC with brain metastases, but there is still controversial about the timing of radiation therapy intervention . This study is a prospective, multi-center, randomized, controlled trial of icotinib combined with early intervention or late intervention radiation therapy for NSCLC patients harboring EGFR mutation with brain metastases. They will be treated with icotinib and divided into 2 groups. Group 1: the radiation therapy will start within 1 month after icotinib treatment; Group2: the patients will be treated with icotinib first, radiation therapy intervene if disease progress.
- Conditions
- Non Small Cell Lung Cancer, Brain Metastases
- Being tested
- Icotinib, SRS/WBRT/HA-WBRT/SMART
- Keywords
- EGFR-TKI, NSCLC, Icotinib, 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
125mg Tid/375mg per day
SRS/WBRT/HA-WBRT/SMARTRadiation
>3 with WBRT/HA-WBRT/SMART or 1-3 with SRS
| Study group | Role | What they receive |
|---|---|---|
| Early intervention | Experimental | Icotinib is administered orally three times per day. Radiation therapy (SRS/ WBRT/ HA-WBRT/SMART) start in 1 month since take icotinib orally. Receives: Drug: Icotinib; Radiation: SRS/WBRT/HA-WBRT/SMART |
| Late intervention | Experimental | Icotinib is administered orally three times per day. Until emerge the progression of the disease, then is given radiation therapy (SRS/WBRT/HA-WBRT/SMART) Receives: Drug: Icotinib; Radiation: SRS/WBRT/HA-WBRT/SMART |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: from date of randomization until the date of death, assessed up to 36 months.
Secondary outcomes (5)
Progression-free survival of intracranial lesions
Measured: from date of randomization until the date of progression, assessed up to 10 months
disease control rate of intracranial lesions
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
measured by FACT-L/LCS 4.0
Measured: from date of randomization until the date of death from any cause, assessed up to 36 months
Neurocognitive function changes measured by MMSE
measured by MMSE
Measured: from date of randomization until the date of death from any cause, assessed up to 36 months
Observing acute and late toxicity assessed by CTCAE v4.0
Assessed by CTCAE v4.0
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 posted15 Aug 2019
- Study start20 Jul 2018
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 296 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chen Ming, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04058704
- Sponsor's protocol ID
- BD-IC-IV99
- Acronym
- SMART
- Status last verified
- Aug 2019
- First submitted
- 11 Aug 2019
- Last updated
- 15 Aug 2019
- 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 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Prospective Study to Determine the Efficiency of Icotinib Combined With Radiation Therapy Early Intervention or Late Intervention For NSCLC Patients With Brain Metastases and EGFR(Epidermal Growth Factor Receptor) Mutation
- ClinicalTrials.gov ID
- NCT04058704
- Acronym / sponsor ID
- SMART / BD-IC-IV99
- Conditions
- Non Small Cell Lung Cancer, Brain Metastases
- Keywords
- EGFR-TKI, NSCLC, Icotinib, radiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 296 participants (estimated)
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Jul 2018 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 15 Aug 2019 (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 alone or in combination with radiation therapy for NSCLC patients harboring EGFR mutation with brain metastases. The primary endpoint is overall survival .
Detailed description
Non-small cell lung cancer (NSCLC) is one of the malignant tumors with the highest incidence of brain metastases, and most patients died due to the progression of brain metastases. Some research show that icotinib combined with radiation therapy can improve the efficiency of NSCLC with brain metastases, but there is still controversial about the timing of radiation therapy intervention . This study is a prospective, multi-center, randomized, controlled trial of icotinib combined with early intervention or late intervention radiation therapy for NSCLC patients harboring EGFR mutation with brain metastases. They will be treated with icotinib and divided into 2 groups. Group 1: the radiation therapy will start within 1 month after icotinib treatment; Group2: the patients will be treated with icotinib first, radiation therapy intervene if disease progress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early intervention | Experimental | Drug: Icotinib, Radiation: SRS/WBRT/HA-WBRT/SMARTIcotinib is administered orally three times per day. Radiation therapy (SRS/ WBRT/ HA-WBRT/SMART) start in 1 month since take icotinib orally. |
| Late intervention | Experimental | Drug: Icotinib, Radiation: SRS/WBRT/HA-WBRT/SMARTIcotinib is administered orally three times per day. Until emerge the progression of the disease, then is given radiation therapy (SRS/WBRT/HA-WBRT/SMART) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histological or cytological confirmation of non-small-cell lung cancer (NSCLC)
- Positive EGFR mutation（Ex19del or 21L858R）
- Primary diagnosis of brain metastases
- Have one or more measurable encephalic lesions according to RECIST
- Extracranial transfer organ≤3
Key exclusion criteria (7 listed)
- Previous usage of EGFR-TKI : gefitinib, erlotinib, icotinib，or any other TKI
- 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 |
|---|---|---|
| Icotinib125mg Tid/375mg per day | Drug | Early intervention, Late intervention |
| SRS/WBRT/HA-WBRT/SMART>3 with WBRT/HA-WBRT/SMART or 1-3 with SRS | Radiation | Early intervention, Late intervention |
Primary outcome
Overall Survival
Time frame: from date of randomization until the date of death, assessed up to 36 months.
5 secondary outcomes
Progression-free survival of intracranial lesions
Time frame: from date of randomization until the date of progression, assessed up to 10 months
disease control rate of intracranial lesions
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
Time frame: from date of randomization until the date of death from any cause, assessed up to 36 months
Neurocognitive function changes measured by MMSE
Time frame: from date of randomization until the date of death from any cause, assessed up to 36 months
Observing acute and late toxicity assessed by CTCAE v4.0
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 15 Aug 2019.
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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.
Chen Ming principal investigator
Zhejiang Cancer Hospital
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 Icotinib and SRS/WBRT/HA-WBRT/SMART 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 12 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 15 Aug 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 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 Chen Ming (+86 18758875572, chenming@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: from date of randomization until the date of death, assessed up to 36 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 15 Aug 2019.