A Window of Opportunity Trial of Afatinib In Early Stage Non-Small Cell Lung Cancer (NSCLC)

NCT ID: NCT01480141

Last Updated: 2013-03-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-08-31

Brief Summary

This study is for patients that have Non-Small Cell Lung Cancer (NSCLC) and he or she will have surgery to remove the tumor. The main purpose of this study is to study how safe and suitable treatment with Afatinib is in participants before surgery to remove the tumor. Another goal of the study is to see if treatment with Afatinib affects the growth and activity of the tumor. Afatinib has not been approved for use by the FDA (Food and Drug Administration) and is experimental.

In some persons, the growth of cancer cells is thought to be stimulated by Epidermal Growth Factor (EGF). This is a protein found in the body which binds to the cell wall to sites called receptors and stimulates cell growth. Some cells have too many receptors and uncontrolled growth and because of this, develop into a cancer tumor. There are several other cancer drugs that bind to these receptors to slow or stop cancer growth such as Gefitinib and erlotinib which are FDA approved and used for the treatment of NSCLC.

The drug Afatinib has been shown to inhibit mutated EGF receptors in clinical trials and may be a candidate for the treatment of NSCLC and a variety of early stage cancers. Participants in this study will take Afatinib by mouth, in pill form, for at least 14 days before having their scheduled surgery to remove their cancer tumor. Participants will be observed for side effects and followed for 30 days after surgery to assess the results after surgery.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Arm Study

Single arm trial where all patients will be treated with afatinib until the day of surgery and for a minimum of two weeks. Patients will receive treatment with afatinib 40mg orally daily.

Group Type: EXPERIMENTAL

BIBW 2992 (Afatinib)

Intervention Type: DRUG

Patients will receive treatment with afatinib 40mg orally daily for a minimum of 2 weeks

Interventions

BIBW 2992 (Afatinib)

Patients will receive treatment with afatinib 40mg orally daily for a minimum of 2 weeks

Intervention Type: DRUG

Eligibility Criteria

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 2992
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

George R. Simon

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

George Simon, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina Hollings Cancer Center

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

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Other Identifiers

101596

Identifier Type: -

Identifier Source: org_study_id