Epidermal Growth Factor ReceptorPhase 2NCT02770014
Rapid Plasma Genotyping For Early Initiation Of Erlotinib In EGFR Mutant Lung Cancer
A Phase 2 study testing Erlotinib in people with Epidermal Growth Factor Receptor and Non-Small Cell Lung Cancer, run by Dana-Farber Cancer Institute at 3 sites in United States.
Trial summary
Patient with Non-Small Cell Lung Cancer (NSCLC) that might have a genetic change (mutation) in the Epidermal Growth Factor Receptor (EGFR) are invited to take part in this study. This research study is evaluating a new blood test that is capable of detecting an EGFR mutation in cancer without a biopsy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epidermal Growth Factor Receptor, Non-Small Cell Lung Cancer
- What is being tested?
- Erlotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2016to 19 Jun 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 or cytologically confirmed metastatic NSCLC including recurrent disease
- EGFR genotype must not be known. However, pending EGFR tumor genotyping is allowed.
- --Participants with positive or pending EGFR mutation on plasma genotyping performed at the central lab are eligible for enrollment, and will not need to repeat initial plasma genotyping on study.
- Tissue must be available for genotyping or biopsy planned to obtain tissue for genotyping. Biopsy requirement may be waived if not technically feasible and plasma genotyping reveals an eligible EGFR mutation (exon 19 del/L858R). Determination of technical feasibility must be made independently of plasma genotyping results.
- Participants must possess at least two of the following clinical characteristics which enrich for EGFR mutations:
- smoked less than 10 pack years
Show all 24Show fewer
- Asian race.
- Adenocarcinoma (including adenosquamous carcinoma) on histology or cytology.
- Participants must have measurable disease with at least one lesion that can be accurately measured in longest dimension as >2 cm with conventional imaging techniques or >1 cm with a spiral CT scan per RECIST v1.1.
- Participants must have progressive, advanced cancer as defined by one of the following:
- Newly diagnosed, untreated advanced disease
- Newly diagnosed, untreated metastatic recurrence of earlier stage disease (previous treatment of early stage disease allowed).
- Clinical determination of progressive disease on previous systemic therapy as evidenced by plan to change treatment. Any number of prior therapies are acceptable excluding previous EGFR kinase inhibitors.
- Age 18 years or older.
- ECOG performance status 0-2.
- Participant must be able to understand and give consent to participate in the study.
- Patient must be a candidate for systemic therapy with erlotinib based on clinical assessment. Patients must meet the following criteria before beginning therapy (Note: these are not required for initial study enrollment and plasma genotyping):
- ECOG performance status of 0-2
- Platelets >75
- AST \& ALT < 3x the upper limit of normal
- Creatinine clearance > 30 mL/min by Cockroft-Gault
- No other contraindication to erlotinib
- Female participants of child-bearing age must agree to use adequate contraception (hormonal, barrier or abstinence) for the duration of the study while receiving erlotinib and undergo a pregnancy test. Any evidence or suspicion of pregnancy should be reported to the treating physician immediately.
- Male participants must agree to use adequate contraception for the duration of the study while receiving erlotinib
Who cannot join
- Participants must not have had chemotherapy within the past 10 days.
- Participants must not have had prior treatment with an EGFR kinase inhibitor, EGFR directed therapy or investigational agent.
- Participants must not have residual adverse events from previous therapy greater than CTCAE v4.0 grade 2 at the time of registration.
- Participants must not have symptomatic brain metastases or brain metastases requiring steroids. Asymptomatic brain metastases not requiring steroids are acceptable.
- Participant must not have a history of allergy to erlotinib.
- Second primary cancer which is active and requiring treatment.
- Participants must not be pregnant or breastfeeding
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Patient with Non-Small Cell Lung Cancer (NSCLC) that might have a genetic change (mutation) in the Epidermal Growth Factor Receptor (EGFR) are invited to take part in this study.
This research study is evaluating a new blood test that is capable of detecting an EGFR mutation in cancer without a biopsy.
Read the detailed description
This research study is a Phase II clinical trial. This research study will determine if a rapid blood test can be used to detect EGFR mutations in patients with newly diagnosed lung cancer and use that information to rapidly start patients on a pill-based therapy.
This blood test has not previously been used to select patients for treatment with Erlotinib without confirming this finding on a biopsy.
- Being tested
- Erlotinib
- Keywords
- Non-Small Cell Lung Cancer, Epidermal Growth Factor Receptor
- 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.
ErlotinibDrug
Also called Tarceva
| Study group | Role | What they receive |
|---|---|---|
| EGFR mutation Positive, Treatment With Erlotinib | Experimental | Eligible EGFR mutations include exon 19 deletion or exon 21 L858R mutation. Erlotinib will be initially dosed at a pre-determine dosage daily, and it will be given on a 6-week cycle with treatment administered on an outpatient basis Receives: Drug: Erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
Number of participants who were alive with evidence of complete or partial response, evaluated using RECIST 1.1 criteria. Patients that underwent rapid plasma genotyping and had an EGFR mutation and who were treated with erlotinib were included in this calculation.
Measured: From date of erlotinib initiation until the date of first documented disease progression or date of death from any cause, whichever came first. ORR was assessed up to 21 months after erlotinib initiation.
Secondary outcomes (2)
Turnaround Time
The turnaround time from study registration to treatment initiation was recorded for the plasma genotyping strategy versus standard tumor genotyping. For rapid plasma genotyping, turnaround time is the time between ordering plasma genotyping and obtaining results; this time period was compared to the turnaround time of obtaining the tumor genotyping results.
Measured: Maximum 38 days
Positive Predictive Value (PPV) And False Negative Rate Of Plasma Genotyping
Concordance between results of plasma genotyping and tumor genotyping, among patients with tissue available for standard genotyping
Measured: PPV and False Negative Rate can be assessed when plasma and tissue results are available for each patient; average plasma result turnaround time was 4 days, versus average of 20 days for tissue result turnaround time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study startJun 2016
- Primary completion16 Apr 2019
- Study completion19 Jun 2019
Why it stopped: Terminated due to Osimertinib approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Epidermal Growth Factor ReceptorStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Inc
- Responsible party
- Principal investigator, Geoffrey Oxnard, MD, Dana-Farber Cancer Institute
- Investigators
- Geoffrey R Oxnard, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02770014
- Sponsor's protocol ID
- 16-093
- Status last verified
- Nov 2019
- First submitted
- 10 May 2016
- Last updated
- 22 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Plasma Genotyping For Early Initiation Of Erlotinib In EGFR Mutant Lung Cancer
- ClinicalTrials.gov ID
- NCT02770014
- Acronym / sponsor ID
- 16-093
- Keywords
- Non-Small Cell Lung Cancer, Epidermal Growth Factor Receptor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to Osimertinib approval
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Astellas Pharma Inc
- Study start
- Jun 2016
- Primary completion
- 16 Apr 2019 (actual)
- Study completion
- 19 Jun 2019 (actual)
- First posted
- 12 May 2016 (estimated)
- Results
- Posted 22 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patient with Non-Small Cell Lung Cancer (NSCLC) that might have a genetic change (mutation) in the Epidermal Growth Factor Receptor (EGFR) are invited to take part in this study.
This research study is evaluating a new blood test that is capable of detecting an EGFR mutation in cancer without a biopsy.
Detailed description
This research study is a Phase II clinical trial. This research study will determine if a rapid blood test can be used to detect EGFR mutations in patients with newly diagnosed lung cancer and use that information to rapidly start patients on a pill-based therapy.
This blood test has not previously been used to select patients for treatment with Erlotinib without confirming this finding on a biopsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EGFR mutation Positive, Treatment With Erlotinib | Experimental | Drug: ErlotinibEligible EGFR mutations include exon 19 deletion or exon 21 L858R mutation. Erlotinib will be initially dosed at a pre-determine dosage daily, and it will be given on a 6-week cycle with treatment administered on an outpatient basis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Histologically or cytologically confirmed metastatic NSCLC including recurrent disease
- EGFR genotype must not be known. However, pending EGFR tumor genotyping is allowed.
- --Participants with positive or pending EGFR mutation on plasma genotyping performed at the central lab are eligible for enrollment, and will not need to repeat initial plasma genotyping on study.
- Tissue must be available for genotyping or biopsy planned to obtain tissue for genotyping. Biopsy requirement may be waived if not technically feasible and plasma genotyping reveals an eligible EGFR mutation (exon 19 del/L858R). Determination of technical feasibility must be made independently of plasma genotyping results.
- Participants must possess at least two of the following clinical characteristics which enrich for EGFR mutations:
Key exclusion criteria (7 listed)
- Participants must not have had chemotherapy within the past 10 days.
- Participants must not have had prior treatment with an EGFR kinase inhibitor, EGFR directed therapy or investigational agent.
- Participants must not have residual adverse events from previous therapy greater than CTCAE v4.0 grade 2 at the time of registration.
- Participants must not have symptomatic brain metastases or brain metastases requiring steroids. Asymptomatic brain metastases not requiring steroids are acceptable.
- Participant must not have a history of allergy to erlotinib.
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 |
|---|---|---|
| ErlotinibAlso: Tarceva | Drug | EGFR mutation Positive, Treatment With Erlotinib |
Primary outcome
Overall Response Rate
Time frame: From date of erlotinib initiation until the date of first documented disease progression or date of death from any cause, whichever came first. ORR was assessed up to 21 months after erlotinib initiation.
Number of participants who were alive with evidence of complete or partial response, evaluated using RECIST 1.1 criteria. Patients that underwent rapid plasma genotyping and had an EGFR mutation and who were treated with erlotinib were included in this calculation.
2 secondary outcomes
Turnaround Time
Time frame: Maximum 38 days
Positive Predictive Value (PPV) And False Negative Rate Of Plasma Genotyping
Time frame: PPV and False Negative Rate can be assessed when plasma and tissue results are available for each patient; average plasma result turnaround time was 4 days, versus average of 20 days for tissue result turnaround time.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Geoffrey R Oxnard, MD principal investigator
Dana-Farber Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Erlotinib in people with Epidermal Growth Factor Receptor and Non-Small Cell Lung Cancer, run by Dana-Farber Cancer Institute at 3 sites in United States.
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 24 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: stopped early, as of the sponsor's last update on 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Yes. Results are posted in the registry (first posted 22 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (time frame: From date of erlotinib initiation until the date of first documented disease progression or date of death from any cause, whichever came first. ORR was assessed up to 21 months after erlotinib initiation.). 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 22 Nov 2019.