Lung CancerPhase 2NCT02271906
The ATTAIN Study: A Therapeutic Trial of Afatinib In the Neoadjuvant Setting
A Phase 2 study testing BIBW 2992 in people with Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if it is tolerable for patients with NSCLC to receive afatinib before surgery. The safety of this drug will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- BIBW 2992
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2015to 16 Aug 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
- Histologically confirmed NSCLC, who are deemed to be surgical candidates by standard criteria. Patients with all types of NSCLC (e.g., adenocarcinoma, squamous cell carcinoma) will be allowed to enroll.
- Patients with Stage IA to IIB disease. Select patients with resectable stage IIIA disease (T3N1, T4N0, T4N1) will also be eligible if approved by the PI.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Measurable disease by RECIST 1.1 criteria
- Mediastinoscopy and/or Endoscopic Bronchial Ultrasound (EBUS) and/or Endoscopic Ultrasound (EUS) for complete surgical staging when clinically indicated
- Serious, active infections must be controlled. Patients may be enrolled while still on antibiotics as long as clinical signs of active infection have resolved.
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- A signed informed consent document (ICD)
- Patients 18 years or older
- Able and willing to take oral medications
Who cannot join
- Known preexisting interstitial lung disease, interstitial pulmonary fibrosis, or connective tissue disorder associated lung disease
- Known N2 nodal disease or distant metastatic disease
- History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to randomization.
- Patients with any of the following lab values at screening should be excluded: Absolute neutrophil count (ANC) < 1500 / mm^3; Platelet count < 100,000 / mm^3; Serum creatinine >/= 1.5 times the upper normal limit or calculated/measured creatinine clearance </= 60 mL/min; Bilirubin >/=1.5mg/dL (> 26 mol/L, SI unit equivalent); Aspartate amino transferase (AST) or Alanine amino transferase (ALT) >/= three (3) times the upper limit of normal.
- Active hepatitis B infection, active hepatitis C infection or known HIV carrier.
- Known or suspected active drug or alcohol abuse
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- Significant or recent acute gastrointestinal disorders with diarrhea as a major symptom for example Crohn's disease, malabsorption or CTC grade >/= 2 diarrhea of any etiology.
- Baseline (< 1 month before treatment) cardiac left ventricular function with resting ejection fraction of less than 50% measured by multigated blood pool imaging of the heart (MUGA scan) or echocardiogram
- Patients receiving other investigational agent.
- History of allergic reactions to anilinoquinazolins like gefitinib, erlotinib, or BIBW2992
- Uncontrolled intercurrent illness that would preclude a patient from undergoing surgery
- Psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant (positive pregnancy test) or lactating
- Inability to comply with study and/or follow-up procedures
- Patients who are not surgical candidates or refuse surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
The goal of this clinical research study is to learn if it is tolerable for patients with NSCLC to receive afatinib before surgery. The safety of this drug will also be studied.
Read the detailed description
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take afatinib by mouth 1 time a day for at least 14 days before your surgery. You should take it at least 1 hour before or 2 hours after a meal. You will sign a separate consent form that describes the surgery and its risks in more detail.
You will keep a diary of when you take the pills. You should bring the diary to each visit, along with your pill bottle so the study staff can count any remaining pills.
Some side effects, such as diarrhea and skin rash, will occur in almost all patients. If you have severe side effects, your dose may be lowered.
Study Visits:
One (1) time a week while you are taking afatinib:
- You will have a physical exam.
- Blood (about 3 teaspoons) will be drawn for routine tests.
Within a week before your surgery:
- You will have a physical exam.
- Blood (about 3 teaspoons) will be drawn for routine tests.
- You will have a PET-CT scan to check the status of the disease.
- You will have a MUGA scan to check your heart function.
On the day of surgery, blood (about 3 teaspoons) will be drawn for research tests, including looking for tumor cells that may be in the blood.
Leftover tissue from surgery will be used for biomarker testing.
Length of Treatment:
You will take your last dose of study drug within 24 hours before your surgery. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over after the follow-up visit.
Follow-Up:
At about 30 days after surgery:
- You will have a physical exam.
- Blood (about 3 teaspoons) will be drawn for routine tests.
It is possible that the study staff will call you instead of the visit above. You will be asked how you are doing. The call should last about 5 minutes.
If you are having side effects from the study drug at the time of the follow-up visit or call, you may have additional follow-up if the doctor thinks it is needed. The follow-up tests, procedures, and schedule will be the doctor's decision depending on the side effects.
This is an investigational study. Afatinib is FDA approved and commercially available to be the first treatment for patients with a specific type of NSCLC that has spread. It is currently being used for research purposes only. The study doctor can explain how the study drug is designed to work.
Up to 20 participants will be enrolled in this study. All will take part at MD Anderson.
- Conditions
- Lung Cancer
- Being tested
- BIBW 2992
- Keywords
- Lung Cancer, Non small cell lung cancer, NSCLC, Adenocarcinoma, Squamous cell carcinoma, BIBW 2992, Afatinib
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIBW 2992Drug
40 mg by mouth daily for a minimum of 14 days, and until the day of surgery.
| Study group | Role | What they receive |
|---|---|---|
| BIBW 2992 | Experimental | BIBW 2992 40 mg by mouth daily for a minimum of 14 days, and until the day of surgery. Receives: Drug: BIBW 2992 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Treatment "Completed"
A patient is declared to have the treatment "completed" if he completes at least 14 days of neoadjuvant treatment, had a thoracotomy for the planned surgical resection, and 30 days of post operative care.
Measured: From the start of neoadjuvant treatment to 30 days post operative care
Secondary outcomes (1)
Number of Participants With a Change in Standard Uptake Value (SUV) From Pre to Post Operative PET-CT
To determine whether pre-operative Afatinib treatment affects metabolic tumor labeling, as measured by PET-CT scanning.
Measured: From the start of neoadjuvant treatment to follow-up, up to 30 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study start1 Jul 2015
- Primary completion16 Aug 2017
- Study completion16 Aug 2017
Why it stopped: Poor Accrual
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 Lung CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- George Simon, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02271906
- Sponsor's protocol ID
- 2013-0305
- Other IDs
- NCI-2015-00357
- Status last verified
- Apr 2019
- First submitted
- 17 Oct 2014
- Last updated
- 30 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ATTAIN Study: A Therapeutic Trial of Afatinib In the Neoadjuvant Setting
- ClinicalTrials.gov ID
- NCT02271906
- Acronym / sponsor ID
- 2013-0305
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer, Non small cell lung cancer, NSCLC, Adenocarcinoma, Squamous cell carcinoma, BIBW 2992, Afatinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor Accrual
- Enrolment
- 2 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 16 Aug 2017 (actual)
- Study completion
- 16 Aug 2017 (actual)
- First posted
- 22 Oct 2014 (estimated)
- Results
- Posted 30 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if it is tolerable for patients with NSCLC to receive afatinib before surgery. The safety of this drug will also be studied.
Detailed description
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take afatinib by mouth 1 time a day for at least 14 days before your surgery. You should take it at least 1 hour before or 2 hours after a meal. You will sign a separate consent form that describes the surgery and its risks in more detail.
You will keep a diary of when you take the pills. You should bring the diary to each visit, along with your pill bottle so the study staff can count any remaining pills.
Some side effects, such as diarrhea and skin rash, will occur in almost all patients. If you have severe side effects, your dose may be lowered.
Study Visits:
One (1) time a week while you are taking afatinib:
- You will have a physical exam.
- Blood (about 3 teaspoons) will be drawn for routine tests.
Within a week before your surgery:
- You will have a physical exam.
- Blood (about 3 teaspoons) will be drawn for routine tests.
- You will have a PET-CT scan to check the status of the disease.
- You will have a MUGA scan to check your heart function.
On the day of surgery, blood (about 3 teaspoons) will be drawn for research tests, including looking for tumor cells that may be in the blood.
Leftover tissue from surgery will be used for biomarker testing.
Length of Treatment:
You will take your last dose of study drug within 24 hours before your surgery. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over after the follow-up visit.
Follow-Up:
At about 30 days after surgery:
- You will have a physical exam.
- Blood (about 3 teaspoons) will be drawn for routine tests.
It is possible that the study staff will call you instead of the visit above. You will be asked how you are doing. The call should last about 5 minutes.
If you are having side effects from the study drug at the time of the follow-up visit or call, you may have additional follow-up if the doctor thinks it is needed. The follow-up tests, procedures, and schedule will be the doctor's decision depending on the side effects.
This is an investigational study. Afatinib is FDA approved and commercially available to be the first treatment for patients with a specific type of NSCLC that has spread. It is currently being used for research purposes only. The study doctor can explain how the study drug is designed to work.
Up to 20 participants will be enrolled in this study. All will take part at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIBW 2992 | Experimental | Drug: BIBW 2992BIBW 2992 40 mg by mouth daily for a minimum of 14 days, and until the day of surgery. |
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 NSCLC, who are deemed to be surgical candidates by standard criteria. Patients with all types of NSCLC (e.g., adenocarcinoma, squamous cell carcinoma) will be allowed to enroll.
- Patients with Stage IA to IIB disease. Select patients with resectable stage IIIA disease (T3N1, T4N0, T4N1) will also be eligible if approved by the PI.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Measurable disease by RECIST 1.1 criteria
- Mediastinoscopy and/or Endoscopic Bronchial Ultrasound (EBUS) and/or Endoscopic Ultrasound (EUS) for complete surgical staging when clinically indicated
Key exclusion criteria (15 listed)
- Known preexisting interstitial lung disease, interstitial pulmonary fibrosis, or connective tissue disorder associated lung disease
- Known N2 nodal disease or distant metastatic disease
- History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to randomization.
- Patients with any of the following lab values at screening should be excluded: Absolute neutrophil count (ANC) < 1500 / mm^3; Platelet count < 100,000 / mm^3; Serum creatinine >/= 1.5 times the upper normal limit or calculated/measured creatinine clearance </= 60 mL/min; Bilirubin >/=1.5mg/dL (> 26 mol/L, SI unit equivalent); Aspartate amino transferase (AST) or Alanine amino transferase (ALT) >/= three (3) times the upper limit of normal.
- Active hepatitis B infection, active hepatitis C infection or known HIV carrier.
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 |
|---|---|---|
| BIBW 299240 mg by mouth daily for a minimum of 14 days, and until the day of surgery. | Drug | BIBW 2992 |
Primary outcome
Number of Patients With Treatment "Completed"
Time frame: From the start of neoadjuvant treatment to 30 days post operative care
A patient is declared to have the treatment "completed" if he completes at least 14 days of neoadjuvant treatment, had a thoracotomy for the planned surgical resection, and 30 days of post operative care.
1 secondary outcome
Number of Participants With a Change in Standard Uptake Value (SUV) From Pre to Post Operative PET-CT
Time frame: From the start of neoadjuvant treatment to follow-up, up to 30 days post surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
George Simon, MD principal investigator
M.D. Anderson Cancer Center
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 BIBW 2992 in people with Lung Cancer, run by M.D. Anderson Cancer Center at 1 site 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 15 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 30 Apr 2019. 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 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 30 Apr 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?
Number of Patients With Treatment "Completed" (time frame: From the start of neoadjuvant treatment to 30 days post operative care). 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 30 Apr 2019.