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OpenTrials
Completed

NCT Number: NCT00567359

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Stanford University, Stanford, California, United States

Loading trial locations.

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erlotinib

Drug

Oral drug taken daily around the same time. Starting dose is 150mg once daily.

Other names: Tarceva

Primary outcomes

  1. 2-year Disease-free Survival

    Time frame: 2 years

    The number of participants alive and free from disease recurrence 2 years after enrollment. Participants were monitored for disease recurrence with the use of surveillance radiographs. When possible and medically appropriate, tissue biopsies were obtained to prove recurrence.

Secondary outcomes

  1. Number of Participants With Treat Related Serious Adverse Events

    Time frame: From the start of treatment until 30 days after the end of treatment, up 13 months total

    Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 3.0) from the start of treatment until 30 days after the end of treatment. Serious adverse events were defined as adverse events that were grade 3 or greater and deemed to be possibly, probably or definitely related to the study treatment.

  2. Median Overall Survival

    Time frame: From the time of registration until death, up to approximately 9 years

    The median amount of time from the time of registration until death due to any cause

  3. Median Disease Free Survival

    Time frame: From registration to disease recurrence or death, up to approximately 9 years

    The median amount of time measured from the time of registration until the time of disease recurrence or death.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Dana-Farber Cancer Institute
  • Genentech, Inc.

Registry information

Official study 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)

Important dates

Study start
2007
Primary completion
2017
Study completion
2017
First posted
Dec 4, 2007
Registry last updated
Dec 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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