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

Phase 2

Terminated

• Conditions: Lung Cancer
• Interventions: Drug: erlotinib

• Registration Number: NCT01189435
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-25
• Study First Submitted QC: 2010-08-25
• Study First Posted: 2010-08-26
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Results First Submitted: 2015-04-07
• Results First Submitted QC: 2015-04-07
• Results First Posted: 2015-04-21
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-17
• Last Update Posted: 2015-11-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
erlotinib	erlotinib	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States