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A Therapeutic Trial of Afatinib in the Neoadjuvant Setting. Molecular Effects of Afatinib: A Window of Opportunity Trial In Early Stage NSCLC

Phase 2
18 Years
90 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

A Therapeutic Trial of Afatinib in the Neoadjuvant Setting. Molecular Effects of Afatinib: A Window of Opportunity Trial In Early Stage NSCLC

Inclusion Criteria:

- Histologically confirmed NSCLC, who are deemed to be surgical candidates by standard
criteria. Patients with all histologies will be allowed to enroll.

Patients with Stage IA to IIIA disease

- 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

- Total bilirubin ≤1.5 mg/dl, SGOT (AST) and SGPT (ALT)≥ 3 x ULN

- Serum creatinine ≤ 1.5 mg/dl

- 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 lung 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.

- Significant or recent acute gastrointestinal disorders with diarrhea as a major
symptom e.g. 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 may not be receiving any other investigational agents.

- History of allergic reactions to anilinoquinazolins like gefitinib, erlotinib or BIBW

- Uncontrolled intercurrent illness that would preclude a patient from undergoing

- Psychiatric illness/social situations that would limit compliance with study

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

The primary endpoint will demonstrate feasibility of neoadjuvant treatment of BIBW 2992 in patients with early stage (IA to IIIA) NSCLC awaiting surgical resection. Feasibility will be assessed based on the ability to complete the treatment for each patient. For our feasibility endpoint we will declare the treatment "completed" if a patient completes at least 14 days of treatment, had a thoracotomy for the planned surgical resection, and 30 days of post operative care.

Outcome Time Frame:

30 days post operative care

Safety Issue:


Principal Investigator

George Simon, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical University of South Carolina Hollings Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

January 2012

Completion Date:

August 2012

Related Keywords:

  • Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Medical University of South Carolina Charleston, South Carolina  29425-0721