NSCLCPhase 2NCT02226757
Paclitaxel-trastuzumab in EGFR-mutated NSCLC Patients
A Phase 2 study testing Paclitaxel-trastzumab in people with NSCLC and HER2-expression, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
This study is a pilot study in EGFR-mutated NSCLC patients who have progressed on standard-dose TKIs. Tumor biopsies will be evaluated for HER2-expression. In case of HER2 expression, patients can participate in the trial after obtaining informed consent. Patients will be treated with weekly paclitaxel-trastuzumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC, HER2-expression, EGFR-mutation
- What is being tested?
- Paclitaxel-trastzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2014to Aug 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed stage IV non-squamous NSCLC patients.
- Patients must have been detected with an activating EGFR mutation at baseline and must have yet progressed on erlotinib, gefitinib or afatinib monotherapy in daily dose of 150 mg, 250 mg or 40 mg respectively. (Patients with unknown mutation status that have exhibited a response to these agents or stable disease for at least 6 months while on treatment with gefitinib or erlotinib are also eligible).
- Rebiopsy after having acquired resistance to TKI-treatment must have been performed and HER2-overexpression (positive immunohistochemistry staining) must have been detected.
- There must be at least one measurable disease site, according to RECIST 1.1 criteria.
- WHO performance status 0-2.
- Willing and able to comply with the study prescriptions.
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- 18 years or older.
- Not pregnant or breast feeding and willing to take adequate contraceptive measures during the study.
- Ability to give written informed consent before patient registration.
Who cannot join
- No uncontrolled infectious disease.
- No other active malignancy.
- No major surgery (excluding diagnostic procedures like e.g. mediastinoscopy or VATS biopsy) in the previous 4 weeks.
- No treatment with investigational drugs.
- No known hypersensitivity to trastuzumab-paclitaxel
- No symptomatic brain metastases.
- History of coronary artery disease, NYHA class III or IV and Left Ventricular Ejection Fraction (LVEF) of <45%.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
VU University medical Center
Amsterdam, 1007MB
Justine Kuiper, MD, +31204442214, jl.kuiper@vumc.nl
About this study
Official title: Paclitaxel-trastuzumab in EGFR-mutated NSCLC Patients After Progression on TKI-treatment; a Pilot-study
This study is a pilot study in EGFR-mutated NSCLC patients who have progressed on standard-dose TKIs. Tumor biopsies will be evaluated for HER2-expression. In case of HER2 expression, patients can participate in the trial after obtaining informed consent.
Patients will be treated with weekly paclitaxel-trastuzumab.
- Conditions
- NSCLC, HER2-expression, EGFR-mutation
- Being tested
- Paclitaxel-trastzumab
- Keywords
- NSCLC, HER2-expression, EGFR-mutation, Trastuzumab, Paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel-trastzumabDrug
Trastuzumab
- Dose:
- First dose: 4 mg/kg IV
- Subsequent doses: 2 mg/kg every week IV.
- The patient must be monitored for at least 6 hours after the start of the first infusion and for at least 2 hours after the start of subsequent infusions.
Paclitaxel
- Dose: 60 mg/m2 IV in 30 minutes, every week, after trastuzumab
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel-trastuzumab | Experimental | Paclitaxel-trastuzumab weekly Receives: Drug: Paclitaxel-trastzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Measured: 6 weeks
Secondary outcomes (3)
Disease control rate
Measured: 6 weeks
progression-free survival
Measured: 2 years
Toxicity
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. dr. E.F. Smit, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02226757
- Sponsor's protocol ID
- HER2-targeting in EGFR-mutated
- Status last verified
- Aug 2014
- First submitted
- 2 Jun 2014
- Last updated
- 27 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paclitaxel-trastuzumab in EGFR-mutated NSCLC Patients After Progression on TKI-treatment; a Pilot-study
- ClinicalTrials.gov ID
- NCT02226757
- Acronym / sponsor ID
- HER2-targeting in EGFR-mutated
- Conditions
- NSCLC, HER2-expression, EGFR-mutation
- Keywords
- NSCLC, HER2-expression, EGFR-mutation, Trastuzumab, Paclitaxel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Aug 2016 (estimated)
- First posted
- 27 Aug 2014 (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 study is a pilot study in EGFR-mutated NSCLC patients who have progressed on standard-dose TKIs. Tumor biopsies will be evaluated for HER2-expression. In case of HER2 expression, patients can participate in the trial after obtaining informed consent.
Patients will be treated with weekly paclitaxel-trastuzumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel-trastuzumab | Experimental | Drug: Paclitaxel-trastzumabPaclitaxel-trastuzumab weekly |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed stage IV non-squamous NSCLC patients.
- Patients must have been detected with an activating EGFR mutation at baseline and must have yet progressed on erlotinib, gefitinib or afatinib monotherapy in daily dose of 150 mg, 250 mg or 40 mg respectively. (Patients with unknown mutation status that have exhibited a response to these agents or stable disease for at least 6 months while on treatment with gefitinib or erlotinib are also eligible).
- Rebiopsy after having acquired resistance to TKI-treatment must have been performed and HER2-overexpression (positive immunohistochemistry staining) must have been detected.
- There must be at least one measurable disease site, according to RECIST 1.1 criteria.
- WHO performance status 0-2.
Key exclusion criteria (7 listed)
- No uncontrolled infectious disease.
- No other active malignancy.
- No major surgery (excluding diagnostic procedures like e.g. mediastinoscopy or VATS biopsy) in the previous 4 weeks.
- No treatment with investigational drugs.
- No known hypersensitivity to trastuzumab-paclitaxel
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 |
|---|---|---|
| Paclitaxel-trastzumabTrastuzumab * Dose: * First dose: 4 mg/kg IV * Subsequent doses: 2 mg/kg every week IV. * The patient must be monitored for at least 6 hours after the start of the first infusion and for at least 2 hours after the start of subsequent infusions. Paclitaxel - Dose: 60 mg/m2 IV in 30 minutes, every week, after trastuzumab | Drug | Paclitaxel-trastuzumab |
Primary outcome
Objective response rate
Time frame: 6 weeks
3 secondary outcomes
Disease control rate
Time frame: 6 weeks
progression-free survival
Time frame: 2 years
Toxicity
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel-trastzumab in people with NSCLC and HER2-expression, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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 9 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 Aug 2014. 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 Netherlands. 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 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 Justine Kuiper, MD (0031204442214, jl.kuiper@vumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: 6 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 27 Aug 2014.