Phase II Trial to Correlate Radiographic Response Induced By Gefitinib With Mutations in the Protein-Tyrosine Kinase Domain of the EGF Receptor Gene
Condition: Lung Cancer; Non-small Cell Lung Cancer; Bronchioloalveolar Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Gefitinib
Intervention description: Patients will receive gefitinib 250 mg po daily for at least 21 days preoperatively (depending on the timing of the surgery). Treatment with gefitinib will be stopped 2 days before the date of surgery.
Patients who have had at least a minor response to gefitinib therapy preoperatively (> 25% reduction in tumor measured bidimensionally) and / or have mutations in the protein-tyrosine kinase domain of the EGF receptor gene identified will continue on the study and will resume gefitinib treatment after at least 7 days from surgery providing adequate wound healing has occurred.
Patients who are determined to be candidates for adjuvant chemotherapy and/or radiation therapy by their treating physician may receive treatment with adjuvant chemotherapy and/or radiation therapy. The post-operative gefitinib will be started after completion of the chemotherapy and/or radiation therapy.
Intervention MeSH terms: Gefitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lung Cancer; Non-small cell lung cancer; Gefitnib; Cancer; NSCLC; bronchioloalveolar cancer; smoker

Summary:

      The purpose of this research study is to:

        -  see if gefitinib pills can shrink Stage 1 or 2 non-small cell lung cancers before
           surgery

        -  see if your non-small cell lung cancer has a mutation in a certain part of the EGFR gene

        -  see if patients whose tumor does shrink with gefitinib treatment are more likely to have
           a mutation in a certain part of the EGFR gene

        -  see if the pattern of protein expression in the blood is related to the tumor's
           sensitivity or resistance to gefitinib treatment.

        -  see if expression of certain genes in the tumor are related to the tumor's sensitivity
           or resistance to gefitinib treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologic confirmation of malignancy at Memorial Sloan-Kettering

          -  Patients must have previously untreated stage I or II NSCLC (T11-2N0M0, T1-2N1M0,
             T3N0M0) and 1 of the following features: never smoker or < 15 pack year smoking
             history and/or bronchioloalveolar cancer (either pure BAC, BAC with focal invasion or
             adenocarcinoma with BAC features)

          -  Patients must have been determined to be operable and resectable by the treating
             thoracic surgeon.

          -  Age >18 years.

          -  Measurable indicator lesions

          -  Ability to understand and the willingness to sign a written informed consent document.

        Exclusion Criteria:

          -  Pregnant or lactating women or women of childbearing potential not using effective
             contraception. Men participating in the trial must also use effective contraception
             when sexually active.

          -  Patients may not be receiving any other investigational agents.

          -  Any history of or evidence of interstitial lung disease (patients with chronic stable
             radiographic changes who are asymptomatic need not be excluded).