Erlotinib Re-Challenge for Recurrent EGFR-mutant Lung Cancer in Patients Who Previously Received Adjuvant Erlotinib or Gefitinib

Study Overview
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Brief Summary
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The purpose of this study is to measure the ability of erlotinib to effectively treat recurrent lung cancer which carries an EGFR mutation lung cancer after prior treatment with erlotinib or gefitinib received in the post-surgical or post-radiation setting.

Official Title
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A Phase 2 Trial of Erlotinib Re-Challenge for Recurrent EGFR-mutant Lung Cancer in Patients Who Previously Received Adjuvant Erlotinib or Gefitinib

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: erlotinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A history of stage I-IIIB NSCLC Previously underdone definitive surgery or radiation Received prior adjuvant treatment or neoadjuvant with erlotinib or gefitinib for a total of at least 3 months at any time Stopped adjuvant erlotinib or neoadjuvant at least 2 months prior to date of first imaging demonstrating recurrence Pathologic evidence of recurrent lung cancer, confirmed at MSKCC EGFR sensitizing mutation (point mutation in exons 18 or 21, or deletion in exon 19) must be documented in the primary or recurrent tumor Tissue from their recurrent tumor must be submitted for EGFR mutation testing, and to evaluate for the presence of the T790M mutation (results do not need to have been reported to be eligible) Measurable disease by RECIST; if received prior irradiation, then must have a target lesion outside the irradiated field Signed informed consent Age > or = to 21 years old Persons of reproductive potential must agree to use an adequate method of contraception throughout treatment and for at least 4 weeks after study drug is stopped Exclusion Criteria: Prior progressive disease while receiving erlotinib or gefitinib therapy Patients with known pre-existing interstitial lung disease Total bilirubin greater than 1.8 mg/dl, excepting patients known to have Gilbert's syndrome AST or ALT greater than five times the upper limit of normal Pregnant or lactating women Medically unfit for erlotinib therapy as determined by treating oncologist

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: erlotinib<br>This will be a single institution, single-arm, two-stage, open-label study of erlotinib in the treatment of patients with recurrent EGFR-mutant lung cancer following completion of adjuvant erlotinib or gefitinib therapy. | Drug: erlotinib<br>* After baseline evaluation, patients will initiate treatment with erlotinib 150 mg daily, or at maximum previous tolerated dose. Initial response assessment will be done during the fourth week of therapy, during the eighth week of therapy, and then every 8 weeks thereafter. Patients will continue on therapy until disease progression by RECIST.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Examine the Objective Response Rate (ORR) of Single-agent Erlotinib | in recurrent EGFR-mutant lung cancer, given to patients who previously received adjuvant erlotinib or gefitinib | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OSI-774, TARCEVA (ERLOTINIB), Lung, recurrent, 10-097, Gefitinib