TerminatedPhase 2NCT02271906

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

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.

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

StatusTerminated
PhasePhase 2
U.S. locations1
SponsorM.D. Anderson Cancer Center
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

Inclusion 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 Exclusion 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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