Erlotinib in Patients With Resected, Early Stage NSCLC With Confirmed Mutations in the EGFR

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Genentech, Inc.
Information provided by (Responsible Party):
Lecia V. Sequist, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00567359
First received: November 30, 2007
Last updated: February 2, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Non-small Cell Lung Cancer
Drug: Erlotinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Adjuvant Erlotinib in Patients With Resected, Early Stage Non-Small Cell Lung Cancer (NSCLC) With Confirmed Mutations in the Epidermal Growth Factor Receptor (EGFR)

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • To determine the 2-year disease-free survival of patients with resected, early stage NSCLC who have activating mutations in the EGFR gene, after treatment with adjuvant erlotinib. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the safety and tolerability of 2 years of adjuvant erlotinib. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • To determine overall survival of this patient sample. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2007
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Erlotinib
    Oral drug taken daily around the same time.
    Other Name: Tarceva
Detailed Description:
  • Erlotinib is a pill taken daily and participants may continue to receive erlotinib for up to two years, as long as the cancer does not return and they do not experience any unacceptable side effects.
  • While participants are receiving erlotinib, they will be asked to return to the clinic for study visits to monitor the status of their disease and their general health. For the first 5 months of erlotinib, they will return to the clinic monthly. After that they will return to the clinic every three months.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567359

Locations
United States, California
Stanford University
Stanford, California, United States, 94305
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hosptial
Boston, Massachusetts, United States, 02114
North Shore Medical Center
Peabody, Massachusetts, United States, 01960
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New York
Memorial Sloan Kettering Cancer Center
New York City, New York, United States, 10021
United States, Ohio
Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
Genentech, Inc.
Investigators
Principal Investigator: Lecia V. Sequist, MD, MPH Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Lecia V. Sequist, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00567359     History of Changes
Other Study ID Numbers: 07-259
Study First Received: November 30, 2007
Last Updated: February 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
NSCLC
erlotinib
epidermal growth factor receptor
EGFR

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Erlotinib
Mitogens
Enzyme Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on October 20, 2014