Non Small Cell Lung CancerPhase 2NCT01746251
Adjuvant Afatinib in Stage I-III NSCLC With EGFR Mutation
A Phase 2 study testing Afatinib in people with Non Small Cell Lung Cancer, run by Massachusetts General Hospital at 4 sites in United States.
Trial summary
This research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is still being studied. 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?
- Afatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2013to Nov 2021
- 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
- Pathologically confirmed diagnosis of non-small cell lung cancer with EGFR mutation
- Complete surgical resection, pathologic stage IA-B, IIA-B, IIIA-B by AJCC 7th Edition staging criteria
- Surgical resection with curative intent was at least 6 months prior to enrollment
- At least 3 weeks have passed since completion of adjuvant chemotherapy or radiotherapy
Who cannot join
- Pregnant or breastfeeding
- History of allergic reactions attributed to compounds of similar chemical composition to afatinib
- Prior exposure to EGFR tyrosine kinase inhibitor
- Evidence of clinically active interstitial lung disease
- Radiographic evidence of recurrent NSCLC prior to afatinib treatment
- Receipt of any experimental treatment within 30 days of start of treatment with afatinib until the end of treatment visit
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- Use of potent P-gp inhibitors and potent P-gp inducers must be avoided during treatment with afatinib
- Individuals with a history of a different malignancy (except: synchronous or metachronous primary non-small cell lung cancers of lower stage than the cancer for which adjuvant treatment is currently being prescribed; disease free for at least 3 years; cervical cancer in situ; basal or squamous cell carcinoma of the skin)
- HIV positive on combination antiretroviral therapy
- Uncontrolled intercurrent illness
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Massachusetts General Hospital
Boston, Massachusetts, 02115
Memorial Sloan Kettering
New York, New York, 10065
Stanford University
Palo Alto, California, 94304
About this study
Official title: Randomized Phase II Study Comparing Concise Versus Prolonged Afatinib as Adjuvant Therapy for Patients With Resected Stage I-III NSCLC With EGFR Mutation
This research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is still being studied. It also means that the FDA has not yet approved afatinib for use in patients.
In this research study the investigators are looking to see if taking afatinib after surgery works better when taken over a short period of time, compared to a long period of time.
Read the detailed description
In order to determine if one is eligible to participate in this study they would be asked to undergo some screening tests or procedures. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that one does not take part in the research study. If the patient has had some of these tests or procedures recently, they may or may not have to be repeated. These tests and procedures include: a medical history, performance status, physical exam and vital signs including height and weight, an assessment of your tumor, routine blood tests, pregnancy test, electrocardiogram, echocardiogram and/or multigated acquisition scan. If these tests show that a patient is eligible to participate in the research study, they will begin the study treatment. If one does not meet the eligibility criteria, they will not be able to participate in this research study.
Because no one knows which of the study options is best, the patients will be "randomized" into one of the study groups. They will take afatinib by mouth every day for either 3 months (short course) or for 2 years (long course). Randomization means that one is put into a group by chance. It is like flipping a coin. Neither the patient, nor the research doctor will choose what group the patient will be in. You will have a 50/50 chance of being placed in any group.
Regardless of which study group one is put in, all patients will take Afatinib by mouth every day. The first cycle will last 28 days. All cycles after that will last 25-31 days. Patients will take their medication (tablets) by mouth once a day, at about the same time each day. They should take Afatinib with a glass of water. Afatinib treatment will continue until the assigned course is completed, or until there are side effects that cannot be tolerated, or one decides to stop study treatment, of if the lung cancer returns.
Patients will be asked to come to the clinic at the following time points:
- Day 1 and 8 of Cycle 1
- Day 1 of Cycles 2, 3 and 4
- Off treatment visit-28 days after the last dose of study drug
If one is assigned to the long course, one will also need to come in for clinic visits on Day 1 of Cycles 7, 10, 13, 16, 19, 22 and 25. If one is assigned to the short course, one does not need to come in for these additional clinic visits.
The following tests and procedures will be done to monitor for side effects of afatinib.
- Routine blood tests-about 2 tablespoons of blood
- Performance status
- Physical exam and vital signs, including height and weight
The following tests and procedures will be done to monitor for recurrence of lung cancer. These visits are the same, regardless of whether one is taking a short course, or a long course of afatinib. There will be clinic visits once every 6 months for 3 years (months 7, 13, 19, 25, 31, 37 and 49), and then one more visit 1 year later. The following tests and procedures will be done at these follow up visits: a CT scan of the chest, routine blood tests, performance status and a physical exam, including height and weight.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Afatinib
- Keywords
- EGFR mutation, Resected
- 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.
AfatinibDrug
| Study group | Role | What they receive |
|---|---|---|
| Concise Afatinib | Active comparator | Afatinib oral daily dose for 3 months Receives: Drug: Afatinib |
| Prolonged Afatinib | Active comparator | Afatinib oral daily dose for 2 years Receives: Drug: Afatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival
The primary objective of this study is to demonstrate that prolonged adjuvant therapy with afatinib will improve recurrence free survival (RFS) compared to a concise adjuvant course in patients with resected stage I-III non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutation.
Measured: 2 years
Secondary outcomes (3)
Number of patients with adverse events
To determine the safety and tolerability of adjuvant afatinib
Measured: 2 years
Molecular genotype of recurrent cancers
We aim to collect clinical data from patients with recurrent NSCLC after treatment with adjuvant afatinib, including molecular characteristics of recurrent cancer analyzed as part of routine care, and time to treatment failure for patients treated with alternative chemotherapies for recurrent lung cancer.
Measured: 2 years
overall survival
To estimate overall survival
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 posted10 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionNov 2020 (estimated)
- Study completionNov 2021 (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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Responsible party
- Principal investigator, Lecia V. Sequist, Massachusetts General Hospital
- Investigators
- Lecia Sequist, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01746251
- Sponsor's protocol ID
- 12-504
- Status last verified
- Jul 2020
- First submitted
- 27 Nov 2012
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Study Comparing Concise Versus Prolonged Afatinib as Adjuvant Therapy for Patients With Resected Stage I-III NSCLC With EGFR Mutation
- ClinicalTrials.gov ID
- NCT01746251
- Acronym / sponsor ID
- 12-504
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- EGFR mutation, Resected
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Study start
- Jan 2013
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 10 Dec 2012 (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 research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is still being studied. It also means that the FDA has not yet approved afatinib for use in patients.
In this research study the investigators are looking to see if taking afatinib after surgery works better when taken over a short period of time, compared to a long period of time.
Detailed description
In order to determine if one is eligible to participate in this study they would be asked to undergo some screening tests or procedures. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that one does not take part in the research study. If the patient has had some of these tests or procedures recently, they may or may not have to be repeated. These tests and procedures include: a medical history, performance status, physical exam and vital signs including height and weight, an assessment of your tumor, routine blood tests, pregnancy test, electrocardiogram, echocardiogram and/or multigated acquisition scan. If these tests show that a patient is eligible to participate in the research study, they will begin the study treatment. If one does not meet the eligibility criteria, they will not be able to participate in this research study.
Because no one knows which of the study options is best, the patients will be "randomized" into one of the study groups. They will take afatinib by mouth every day for either 3 months (short course) or for 2 years (long course). Randomization means that one is put into a group by chance. It is like flipping a coin. Neither the patient, nor the research doctor will choose what group the patient will be in. You will have a 50/50 chance of being placed in any group.
Regardless of which study group one is put in, all patients will take Afatinib by mouth every day. The first cycle will last 28 days. All cycles after that will last 25-31 days. Patients will take their medication (tablets) by mouth once a day, at about the same time each day. They should take Afatinib with a glass of water. Afatinib treatment will continue until the assigned course is completed, or until there are side effects that cannot be tolerated, or one decides to stop study treatment, of if the lung cancer returns.
Patients will be asked to come to the clinic at the following time points:
- Day 1 and 8 of Cycle 1
- Day 1 of Cycles 2, 3 and 4
- Off treatment visit-28 days after the last dose of study drug
If one is assigned to the long course, one will also need to come in for clinic visits on Day 1 of Cycles 7, 10, 13, 16, 19, 22 and 25. If one is assigned to the short course, one does not need to come in for these additional clinic visits.
The following tests and procedures will be done to monitor for side effects of afatinib.
- Routine blood tests-about 2 tablespoons of blood
- Performance status
- Physical exam and vital signs, including height and weight
The following tests and procedures will be done to monitor for recurrence of lung cancer. These visits are the same, regardless of whether one is taking a short course, or a long course of afatinib. There will be clinic visits once every 6 months for 3 years (months 7, 13, 19, 25, 31, 37 and 49), and then one more visit 1 year later. The following tests and procedures will be done at these follow up visits: a CT scan of the chest, routine blood tests, performance status and a physical exam, including height and weight.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concise Afatinib | Active comparator | Drug: AfatinibAfatinib oral daily dose for 3 months |
| Prolonged Afatinib | Active comparator | Drug: AfatinibAfatinib oral daily dose for 2 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pathologically confirmed diagnosis of non-small cell lung cancer with EGFR mutation
- Complete surgical resection, pathologic stage IA-B, IIA-B, IIIA-B by AJCC 7th Edition staging criteria
- Surgical resection with curative intent was at least 6 months prior to enrollment
- At least 3 weeks have passed since completion of adjuvant chemotherapy or radiotherapy
Key exclusion criteria (10 listed)
- Pregnant or breastfeeding
- History of allergic reactions attributed to compounds of similar chemical composition to afatinib
- Prior exposure to EGFR tyrosine kinase inhibitor
- Evidence of clinically active interstitial lung disease
- Radiographic evidence of recurrent NSCLC prior to afatinib treatment
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 |
|---|---|---|
| Afatinib | Drug | Concise Afatinib, Prolonged Afatinib |
Primary outcome
Recurrence-free survival
Time frame: 2 years
The primary objective of this study is to demonstrate that prolonged adjuvant therapy with afatinib will improve recurrence free survival (RFS) compared to a concise adjuvant course in patients with resected stage I-III non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutation.
3 secondary outcomes
Number of patients with adverse events
Time frame: 2 years
Molecular genotype of recurrent cancers
Time frame: 2 years
overall survival
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 7 Jul 2020.
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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 Sequist, MD, MPH principal investigator
Massachusetts General Hospital
4 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 Afatinib in people with Non Small Cell Lung Cancer, run by Massachusetts General Hospital at 4 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 4 inclusion and 10 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 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Results are not available in the source record.
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?
Recurrence-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 7 Jul 2020.