TerminatedPhase 2NCT02271906
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedBIBW 2992

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 30, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?M.D. Anderson Cancer Center

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
M.D. Anderson Cancer Center
Interventions being studied
Drug: BIBW 2992
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

1. 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. 2. 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. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 4. Measurable disease by RECIST 1.1 criteria 5. Mediastinoscopy and/or Endoscopic Bronchial Ultrasound (EBUS) and/or Endoscopic Ultrasound (EUS) for complete surgical staging when clinically indicated 6. Serious, active infections must be controlled. Patients may be enrolled while still on antibiotics as long as clinical signs of active infection have resolved. 7. A signed informed consent document (ICD) 8. Patients 18 years or older 9. Able and willing to take oral medications

Reasons someone may not be able to joinExclusion criteria

1. Known preexisting interstitial lung disease, interstitial pulmonary fibrosis, or connective tissue disorder associated lung disease 2. Known N2 nodal disease or distant metastatic disease 3. 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. 4. 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. 5. Active hepatitis B infection, active hepatitis C infection or known HIV carrier. 6. Known or suspected active drug or alcohol abuse 7. 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. 8. 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 9. Patients receiving other investigational agent. 10. History of allergic reactions to anilinoquinazolins like gefitinib, erlotinib, or BIBW2992 11. Uncontrolled intercurrent illness that would preclude a patient from undergoing surgery 12. Psychiatric illness/social situations that would limit compliance with study requirements 13. Pregnant (positive pregnancy test) or lactating 14. Inability to comply with study and/or follow-up procedures 15. Patients who are not surgical candidates or refuse surgery

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Texas MD Anderson Cancer CenterHouston, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 30, 2019. Always confirm current availability with the study team.

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