Nonsmall Cell Lung CancerPhase 2NCT03002844
EGFR-TKI With/Without Chemotherapy in NSCLC Patients With Both EGFR Mutation and BIM Deletion Polymorphism
A Phase 2 study testing EGFR-TK Inhibitor, EGFR-TKI and EGFR-TKI and Chemotherapy in people with Nonsmall Cell Lung Cancer and EGFR Gene Mutation, run by Shanghai Pulmonary Hospital, Shanghai, China.
Trial summary
BIM deletion polymorphism might be associated with a poor clinical response to EGFR-TKIs in patients who had NSCLC with EGFR mutations. In the study, the investigators want to use EGFR-TKI with/without chemotherapy as first line treatment in stage IIIB/IV NSCLC patients with both EGFR mutation and BIM deletion… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nonsmall Cell Lung Cancer, EGFR Gene Mutation
- What is being tested?
- EGFR-TK Inhibitor, EGFR-TKI and EGFR-TKI and Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Dec 2018
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic Stage IV Non-Small Cell Lung Cancer (NSCLC)
- Must have measurable or non-measurable disease
- Must be able to comply with study and follow-up procedures
Who cannot join
- Small cell, carcinoid, or mixed small cell lung cancer
- Malignancies within 3 years except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer
- Symptomatic or untreated brain metastases Prior systemic chemotherapy for NSCLC
- Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months prior to Day 1, or serious cardiac arrhythmia requiring medication
- History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications
- Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, or prior surgical procedures affecting absorption
- Pregnancy or lactation
Trial locations and contacts
No sites are listed yet.
About this study
BIM deletion polymorphism might be associated with a poor clinical response to EGFR-TKIs in patients who had NSCLC with EGFR mutations. In the study, the investigators want to use EGFR-TKI with/without chemotherapy as first line treatment in stage IIIB/IV NSCLC patients with both EGFR mutation and BIM deletion polymorphism.
Read the detailed description
BIM deletion polymorphism was a poor clinical response marker to EGFR-TKIs in NSCLC patients who had EGFR mutations. In the study, the investigators want to use EGFR-TKI with chemotherapy as 1 st treatment in stage IIIB/IV NSCLC patients with both EGFR mutation and BIM deletion polymorphism.
- Conditions
- Nonsmall Cell Lung Cancer, EGFR Gene Mutation
- Being tested
- EGFR-TK Inhibitor, EGFR-TKI, EGFR-TKI and Chemotherapy
- 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.
EGFR-TK InhibitorDrug
Also called gefitinib
EGFR-TKI (gefitinib 250mg per day)
EGFR-TKIDrug
Also called gefitinib
EGFR-TKI (gefitinib 250mg per day)
EGFR-TKI and ChemotherapyDrug
Also called EGFR-TKI and pemetrexed/gemcitabine and carboplatin
pemetrexed 500mg per kg q3w/gemcitabine 1000mg per kg q3w and carboplatin AUC=5 q3w
| Study group | Role | What they receive |
|---|---|---|
| EGFR-TKI and Chemotherapy | Experimental | gefitinib with pemetrexed/gemcitabine and carboplatin Receives: Drug: EGFR-TKI; Drug: EGFR-TKI and Chemotherapy |
| EGFR-TK Inhibitor | Experimental | Gefitinib Receives: Drug: EGFR-TK Inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress Free Survival
Measured: up to 12 months
Secondary outcomes (3)
Overall Survival
Measured: up to 24 months
Overall Response Rate
Measured: up to 12 months
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Safety
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionAug 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonsmall 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caicun Zhou, Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- Caicun Zhou, MD, PHD, Principal investigator, Shanghai Pulmonary Hospital, Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03002844
- Sponsor's protocol ID
- ShanghaiPH002
- Status last verified
- Dec 2016
- First submitted
- 14 Dec 2016
- Last updated
- 28 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EGFR-TKI With/Without Chemotherapy in NSCLC Patients With Both EGFR Mutation and BIM Deletion Polymorphism
- ClinicalTrials.gov ID
- NCT03002844
- Acronym / sponsor ID
- ShanghaiPH002
- Conditions
- Nonsmall Cell Lung Cancer, EGFR Gene Mutation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 26 Dec 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.
BIM deletion polymorphism might be associated with a poor clinical response to EGFR-TKIs in patients who had NSCLC with EGFR mutations. In the study, the investigators want to use EGFR-TKI with/without chemotherapy as first line treatment in stage IIIB/IV NSCLC patients with both EGFR mutation and BIM deletion polymorphism.
Detailed description
BIM deletion polymorphism was a poor clinical response marker to EGFR-TKIs in NSCLC patients who had EGFR mutations. In the study, the investigators want to use EGFR-TKI with chemotherapy as 1 st treatment in stage IIIB/IV NSCLC patients with both EGFR mutation and BIM deletion polymorphism.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EGFR-TKI and Chemotherapy | Experimental | Drug: EGFR-TKI, Drug: EGFR-TKI and Chemotherapygefitinib with pemetrexed/gemcitabine and carboplatin |
| EGFR-TK Inhibitor | Experimental | Drug: EGFR-TK InhibitorGefitinib |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent
- Histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic Stage IV Non-Small Cell Lung Cancer (NSCLC)
- Must have measurable or non-measurable disease
- Must be able to comply with study and follow-up procedures
Key exclusion criteria (7 listed)
- Small cell, carcinoid, or mixed small cell lung cancer
- Malignancies within 3 years except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer
- Symptomatic or untreated brain metastases Prior systemic chemotherapy for NSCLC
- Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months prior to Day 1, or serious cardiac arrhythmia requiring medication
- History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications
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-TK InhibitorAlso: gefitinibEGFR-TKI (gefitinib 250mg per day) | Drug | EGFR-TK Inhibitor |
| EGFR-TKIAlso: gefitinibEGFR-TKI (gefitinib 250mg per day) | Drug | EGFR-TKI and Chemotherapy |
| EGFR-TKI and ChemotherapyAlso: EGFR-TKI and pemetrexed/gemcitabine and carboplatinpemetrexed 500mg per kg q3w/gemcitabine 1000mg per kg q3w and carboplatin AUC=5 q3w | Drug | EGFR-TKI and Chemotherapy |
Primary outcome
Progress Free Survival
Time frame: up to 12 months
3 secondary outcomes
Overall Survival
Time frame: up to 24 months
Overall Response Rate
Time frame: up to 12 months
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2016.
- Individual participant dataSharing planned: No
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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.
Caicun Zhou, MD, PHD principal investigator
Shanghai Pulmonary Hospital, Tongji University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EGFR-TK Inhibitor, EGFR-TKI and EGFR-TKI and Chemotherapy in people with Nonsmall Cell Lung Cancer and EGFR Gene Mutation, run by Shanghai Pulmonary Hospital, Shanghai, 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 4 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 28 Dec 2016. 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 Caicun Zhou, MD PHD (8613301825532, caicunzhoudr@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progress Free Survival (time frame: 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 28 Dec 2016.