The ATTAIN Study: A Therapeutic Trial of Afatinib In the Neoadjuvant Setting
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: BIBW 2992
Intervention description: 40 mg by mouth daily for a minimum of 14 days, and until the day of surgery.
Intervention MeSH terms: Afatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lung Cancer; Non small cell lung cancer; NSCLC; Adenocarcinoma; Squamous cell carcinoma; BIBW 2992; Afatinib

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.
    

Eligibility criteria:

        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