Non-small Cell Lung CancerPhase 2NCT00567359
Erlotinib in Patients With Resected, Early Stage NSCLC With Confirmed Mutations in the EGFR
A Phase 2 study testing Erlotinib in people with Non-small Cell Lung Cancer, run by Massachusetts General Hospital at 8 sites in United States.
Trial summary
In this research study erlotinib will be given to eligible participants whose lung cancer has been removed by surgery. Eligible patients have adenocarcinoma, a type of non-small lung cancer, and must have 1 or more of the following characteristics: be female, be of Asian or Pacific Rim descent and/or be a never… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Erlotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 8 sitesUnited States
- Study dates
- Dec 2007to Dec 2017
- 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
- Pathologically confirmed diagnosis of NSCLC of adenocarcinoma histology
- Stage IA-B, IIA-B, or IIIA by the American Joint Committee on Cancer 7th edition staging criteria
- Patients must have undergone surgical resection with curative intent within 6 months of enrollment
- Sufficient tumor tissue available for EGFR mutation analysis
- At least ONE of the following patient characteristics: previously detected deletion 19 or L858R EGFR mutation, female sex, history of never smoking, or Asian/Pacific Rim ethnicity (to be enrolled in the screening portion of trial).
- 18 years of age or older
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- Tumor samples must have either exon 19 deletion mutations or the exon 21 L858R point mutation
- ECOG Performance status of 0,1, or 2
- Adequate organ function as outlined in protocol
Who cannot join
- Radiographic evidence of recurrent NSCLC prior to erlotinib treatment
- Confirmed T790M resistance mutation in the primary tumor sample
- Prior exposure to EGFR tyrosine kinase inhibitors
- Known hypersensitivity to erlotinib, gefitinib, or any closely related drug
- Pregnant or breastfeeding women
- Any evidence of clinically active interstitial lung disease
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- Current use of enzyme-inducing anti-epileptic drugs, including carbamazepine, oxcarbazepine, phenytoin, fosphenytoin, phenobarbital, and primidone
- Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
- Use of any non-FDA approved or investigational agent within 2 weeks of enrolling onto the trial, or failure to recover from the side effects of any of these agents
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Massachusetts General Hosptial
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Taussig Cancer Center
Cleveland, Ohio, 44195
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
North Shore Medical Center
Peabody, Massachusetts, 01960
Washington University School of Medicine
St Louis, Missouri, 63110
Stanford University
Stanford, California, 94305
About this study
Official title: A Phase II Trial of Adjuvant Erlotinib in Patients With Resected, Early Stage Non-Small Cell Lung Cancer (NSCLC) With Confirmed Mutations in the Epidermal Growth Factor Receptor (EGFR)
In this research study erlotinib will be given to eligible participants whose lung cancer has been removed by surgery. Eligible patients have adenocarcinoma, a type of non-small lung cancer, and must have 1 or more of the following characteristics: be female, be of Asian or Pacific Rim descent and/or be a never smoker. The potential participant's tumor will be examined for Epidermal growth factor (EGFR) mutations. EGFR is a protein that is overexpressed in most non-small cell lung cancers. Some EGFR has been found to have specific mutations and the participant must have one of these mutations in his tumor.
Erlotinib blocks this protein and may control tumor growth and increase survival. Previous research has shown that erlotinib is most effective for people who have these specific mutations in the EGFR.
Read the detailed description
- Erlotinib is a pill taken daily and participants may continue to receive erlotinib for up to two years, as long as the cancer does not return and they do not experience any unacceptable side effects.
- While participants are receiving erlotinib, they will be asked to return to the clinic for study visits to monitor the status of their disease and their general health. For the first 5 months of erlotinib, they will return to the clinic monthly. After that they will return to the clinic every three months.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Erlotinib
- Keywords
- NSCLC, erlotinib, epidermal growth factor receptor, EGFR
- 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
Oral drug taken daily around the same time. Starting dose is 150mg once daily.
| Study group | Role | What they receive |
|---|---|---|
| Erlotinib | Experimental | Not described Receives: Drug: Erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year Disease-free Survival
The number of participants alive and free from disease recurrence 2 years after enrollment. Participants were monitored for disease recurrence with the use of surveillance radiographs. When possible and medically appropriate, tissue biopsies were obtained to prove recurrence.
Measured: 2 years
Secondary outcomes (3)
Number of Participants With Treat Related Serious Adverse Events
Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 3.0) from the start of treatment until 30 days after the end of treatment. Serious adverse events were defined as adverse events that were grade 3 or greater and deemed to be possibly, probably or definitely related to the study treatment.
Measured: From the start of treatment until 30 days after the end of treatment, up 13 months total
Median Overall Survival
The median amount of time from the time of registration until death due to any cause
Measured: From the time of registration until death, up to approximately 9 years
Median Disease Free Survival
The median amount of time measured from the time of registration until the time of disease recurrence or death.
Measured: From registration to disease recurrence or death, up to approximately 9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionDec 2017
- Study completionDec 2017
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 Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Genentech, Inc.
- Responsible party
- Principal investigator, Lecia V. Sequist, Massachusetts General Hospital
- Investigators
- Lecia V. Sequist, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00567359
- Sponsor's protocol ID
- 07-259
- Status last verified
- Nov 2018
- First submitted
- 30 Nov 2007
- Last updated
- 11 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Adjuvant Erlotinib in Patients With Resected, Early Stage Non-Small Cell Lung Cancer (NSCLC) With Confirmed Mutations in the Epidermal Growth Factor Receptor (EGFR)
- ClinicalTrials.gov ID
- NCT00567359
- Acronym / sponsor ID
- 07-259
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- NSCLC, erlotinib, epidermal growth factor receptor, EGFR
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Genentech, Inc.
- Study start
- Dec 2007
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 4 Dec 2007 (estimated)
- Results
- Posted 11 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this research study erlotinib will be given to eligible participants whose lung cancer has been removed by surgery. Eligible patients have adenocarcinoma, a type of non-small lung cancer, and must have 1 or more of the following characteristics: be female, be of Asian or Pacific Rim descent and/or be a never smoker. The potential participant's tumor will be examined for Epidermal growth factor (EGFR) mutations. EGFR is a protein that is overexpressed in most non-small cell lung cancers. Some EGFR has been found to have specific mutations and the participant must have one of these mutations in his tumor.
Erlotinib blocks this protein and may control tumor growth and increase survival. Previous research has shown that erlotinib is most effective for people who have these specific mutations in the EGFR.
Detailed description
- Erlotinib is a pill taken daily and participants may continue to receive erlotinib for up to two years, as long as the cancer does not return and they do not experience any unacceptable side effects.
- While participants are receiving erlotinib, they will be asked to return to the clinic for study visits to monitor the status of their disease and their general health. For the first 5 months of erlotinib, they will return to the clinic monthly. After that they will return to the clinic every three months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erlotinib | Experimental | Drug: Erlotinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Pathologically confirmed diagnosis of NSCLC of adenocarcinoma histology
- Stage IA-B, IIA-B, or IIIA by the American Joint Committee on Cancer 7th edition staging criteria
- Patients must have undergone surgical resection with curative intent within 6 months of enrollment
- Sufficient tumor tissue available for EGFR mutation analysis
- At least ONE of the following patient characteristics: previously detected deletion 19 or L858R EGFR mutation, female sex, history of never smoking, or Asian/Pacific Rim ethnicity (to be enrolled in the screening portion of trial).
Key exclusion criteria (9 listed)
- Radiographic evidence of recurrent NSCLC prior to erlotinib treatment
- Confirmed T790M resistance mutation in the primary tumor sample
- Prior exposure to EGFR tyrosine kinase inhibitors
- Known hypersensitivity to erlotinib, gefitinib, or any closely related drug
- Pregnant or breastfeeding 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 |
|---|---|---|
| ErlotinibAlso: TarcevaOral drug taken daily around the same time. Starting dose is 150mg once daily. | Drug | Erlotinib |
Primary outcome
2-year Disease-free Survival
Time frame: 2 years
The number of participants alive and free from disease recurrence 2 years after enrollment. Participants were monitored for disease recurrence with the use of surveillance radiographs. When possible and medically appropriate, tissue biopsies were obtained to prove recurrence.
3 secondary outcomes
Number of Participants With Treat Related Serious Adverse Events
Time frame: From the start of treatment until 30 days after the end of treatment, up 13 months total
Median Overall Survival
Time frame: From the time of registration until death, up to approximately 9 years
Median Disease Free Survival
Time frame: From registration to disease recurrence or death, up to approximately 9 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Lecia V. Sequist, MD, MPH principal investigator
Massachusetts General Hospital
8 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 Non-small Cell Lung Cancer, run by Massachusetts General Hospital at 8 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 9 inclusion and 9 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: finished, as of the sponsor's last update on 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 11 Dec 2018). 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?
2-year Disease-free Survival (time frame: 2 years). 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 11 Dec 2018.