Back to results

The ATTAIN Study: A Therapeutic Trial of Afatinib In the Neoadjuvant Setting

Primary Purpose

Lung Cancer

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

BIBW 2992

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Lung Cancer, Non small cell lung cancer, NSCLC, Adenocarcinoma, Squamous cell carcinoma, BIBW 2992, Afatinib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
A signed informed consent document (ICD)
Patients 18 years or older
Able and willing to take oral medications

Exclusion Criteria:

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
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

Sites / Locations

University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BIBW 2992

Arm Description

BIBW 2992 40 mg by mouth daily for a minimum of 14 days, and until the day of surgery.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT02271906

First Posted

October 17, 2014

Last Updated

April 8, 2019

Sponsor

M.D. Anderson Cancer Center

Collaborators

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT02271906

Brief Title

The ATTAIN Study: A Therapeutic Trial of Afatinib In the Neoadjuvant Setting

Official Title

The ATTAIN Study: A Therapeutic Trial of Afatinib In the Neoadjuvant Setting

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Terminated

Why Stopped

Poor Accrual

Study Start Date

July 1, 2015 (Actual)

Primary Completion Date

August 16, 2017 (Actual)

Study Completion Date

August 16, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Anderson Cancer Center

Collaborators

Boehringer Ingelheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

Keywords

Lung Cancer, Non small cell lung cancer, NSCLC, Adenocarcinoma, Squamous cell carcinoma, BIBW 2992, Afatinib

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BIBW 2992

Arm Type

Experimental

Arm Description

BIBW 2992 40 mg by mouth daily for a minimum of 14 days, and until the day of surgery.

Intervention Type

Drug

Intervention Name(s)

BIBW 2992

Intervention Description

40 mg by mouth daily for a minimum of 14 days, and until the day of surgery.

Primary Outcome Measure Information:

Title

Number of Patients With Treatment "Completed"

Description

Time Frame

From the start of neoadjuvant treatment to 30 days post operative care

Secondary Outcome Measure Information:

Title

Number of Participants With a Change in Standard Uptake Value (SUV) From Pre to Post Operative PET-CT

Description

To determine whether pre-operative Afatinib treatment affects metabolic tumor labeling, as measured by PET-CT scanning.

Time Frame

From the start of neoadjuvant treatment to follow-up, up to 30 days post surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. A signed informed consent document (ICD) Patients 18 years or older Able and willing to take oral medications Exclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

George Simon, MD

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Texas MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.mdanderson.org

Description

University of Texas MD Anderson Cancer Center Website

Learn more about this trial

The ATTAIN Study: A Therapeutic Trial of Afatinib In the Neoadjuvant Setting

We'll reach out to this number within 24 hrs