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

• ClinicalTrials.gov Identifier: NCT01189435
• Recruitment Status: Terminated
• First Posted: August 26, 2010
• Results First Posted: April 21, 2015
• Last Update Posted: November 18, 2015
• Sponsor: Memorial Sloan Kettering Cancer Center
• Information provided by (Responsible Party): Memorial Sloan Kettering Cancer Center

Tracking Information

• First Submitted Date: August 25, 2010
• First Posted Date: August 26, 2010
• Results First Submitted Date: April 7, 2015
• Results First Posted Date: April 21, 2015
• Last Update Posted Date: November 18, 2015
• Study Start Date: August 2010
• Actual Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 5, 2011)

To Examine the Objective Response Rate (ORR) of Single-agent Erlotinib [ Time Frame: 2 years ]

in recurrent EGFR-mutant lung cancer, given to patients who previously received adjuvant erlotinib or gefitinib

Original Primary Outcome Measures (submitted: August 25, 2010)

To Examine the Objective Response Rate (ORR) of Single-agent Erlotinib [ Time Frame: 2 years ]

in recurrent EGFR-mutant lung cancer, given to patients who previously received adjuvant erlotinib

• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (submitted: August 25, 2010)

• To examine the progression free survival (PFS) [ Time Frame: 2 years ]
  of patients receiving single-agent erlotinib for recurrent EGFR-mutant lung cancer following previous adjuvant erlotinib
• To examine overall survival (OS) [ Time Frame: 2 years ]
  of patients receiving single-agent erlotinib for recurrent EGFR-mutant lung cancer following previous adjuvant erlotinib
• To estimate the prevalence of EGFR T790M mutation [ Time Frame: 2 years ]
  in patients who have recurrent lung cancer after stopping adjuvant erlotinib
• To examine the correlation of T790M mutation [ Time Frame: 2 years ]
  with ORR and PFS in patients receiving erlotinib
• To estimate the accuracy of circulating tumor cells (CTCs) [ Time Frame: Within 2 weeks of starting erlotinib ]
  at non-invasively detecting EGFR and T790M mutations in patients with recurrent lung cancer.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Erlotinib Re-Challenge for Recurrent EGFR-mutant Lung Cancer in Patients Who Previously Received Adjuvant Erlotinib or Gefitinib
• Official Title: A Phase 2 Trial of Erlotinib Re-Challenge for Recurrent EGFR-mutant Lung Cancer in Patients Who Previously Received Adjuvant Erlotinib or Gefitinib
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Lung Cancer

Intervention

Drug: erlotinib

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.

Study Arms

Experimental: 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.

Intervention: Drug: erlotinib

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: November 8, 2011): 2
• Original Estimated Enrollment (submitted: August 25, 2010): 21
• Actual Study Completion Date: January 2012
• Actual Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01189435
• Other Study ID Numbers: 10-097
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Memorial Sloan Kettering Cancer Center
• Study Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Not Provided

Investigators

• Principal Investigator: Christopher Azzoli, MD; Memorial Sloan Kettering Cancer Center

• PRS Account: Memorial Sloan Kettering Cancer Center
• Verification Date: October 2015