Erlotinib in Patients With Resected, Early Stage NSCLC With Confirmed Mutations in the EGFR
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Erlotinib
Intervention description: Oral drug taken daily around the same time. Starting dose is 150mg once daily.
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NSCLC; erlotinib; epidermal growth factor receptor; EGFR

Summary:

      In this research study erlotinib will be given to eligible participants whose lung cancer has
      been removed by surgery. Eligible patients have adenocarcinoma, a type of non-small lung
      cancer, and must have 1 or more of the following characteristics: be female, be of Asian or
      Pacific Rim descent and/or be a never smoker. The potential participant's tumor will be
      examined for Epidermal growth factor (EGFR) mutations. EGFR is a protein that is
      overexpressed in most non-small cell lung cancers. Some EGFR has been found to have specific
      mutations and the participant must have one of these mutations in his tumor.

      Erlotinib blocks this protein and may control tumor growth and increase survival. Previous
      research has shown that erlotinib is most effective for people who have these specific
      mutations in the EGFR.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically confirmed diagnosis of NSCLC of adenocarcinoma histology

          -  Stage IA-B, IIA-B, or IIIA by the American Joint Committee on Cancer 7th edition
             staging criteria

          -  Patients must have undergone surgical resection with curative intent within 6 months
             of enrollment

          -  Sufficient tumor tissue available for EGFR mutation analysis

          -  At least ONE of the following patient characteristics: previously detected deletion 19
             or L858R EGFR mutation, female sex, history of never smoking, or Asian/Pacific Rim
             ethnicity (to be enrolled in the screening portion of trial).

          -  18 years of age or older

          -  Tumor samples must have either exon 19 deletion mutations or the exon 21 L858R point
             mutation

          -  ECOG Performance status of 0,1, or 2

          -  Adequate organ function as outlined in protocol

        Exclusion Criteria:

          -  Radiographic evidence of recurrent NSCLC prior to erlotinib treatment

          -  Confirmed T790M resistance mutation in the primary tumor sample

          -  Prior exposure to EGFR tyrosine kinase inhibitors

          -  Known hypersensitivity to erlotinib, gefitinib, or any closely related drug

          -  Pregnant or breastfeeding women

          -  Any evidence of clinically active interstitial lung disease

          -  Current use of enzyme-inducing anti-epileptic drugs, including carbamazepine,
             oxcarbazepine, phenytoin, fosphenytoin, phenobarbital, and primidone

          -  Evidence of any other significant clinical disorder or laboratory finding that makes
             it undesirable for the patient to participate in the study

          -  Use of any non-FDA approved or investigational agent within 2 weeks of enrolling onto
             the trial, or failure to recover from the side effects of any of these agents