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

Primary Purpose

Non-small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Erlotinib
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring NSCLC, erlotinib, epidermal growth factor receptor, EGFR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University
  • Massachusetts General Hosptial
  • Beth Israel Deaconess Medical Center
  • Dana-Farber Cancer Institute
  • North Shore Medical Center
  • Washington University School of Medicine
  • Memorial Sloan Kettering Cancer Center
  • Taussig Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Erlotinib

Arm Description

Outcomes

Primary Outcome Measures

2-year Disease-free Survival
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 Outcome Measures

Number of Participants With Treat Related Serious Adverse Events
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.
Median Overall Survival
The median amount of time from the time of registration until death due to any cause
Median Disease Free Survival
The median amount of time measured from the time of registration until the time of disease recurrence or death.

Full Information

First Posted
November 30, 2007
Last Updated
November 20, 2018
Sponsor
Massachusetts General Hospital
Collaborators
Dana-Farber Cancer Institute, Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00567359
Brief Title
Erlotinib in Patients With Resected, Early Stage NSCLC With Confirmed Mutations in the EGFR
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)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Dana-Farber Cancer Institute, Genentech, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
NSCLC, erlotinib, epidermal growth factor receptor, EGFR

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Erlotinib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Erlotinib
Other Intervention Name(s)
Tarceva
Intervention Description
Oral drug taken daily around the same time. Starting dose is 150mg once daily.
Primary Outcome Measure Information:
Title
2-year Disease-free Survival
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Number of Participants With Treat Related Serious Adverse Events
Description
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.
Time Frame
From the start of treatment until 30 days after the end of treatment, up 13 months total
Title
Median Overall Survival
Description
The median amount of time from the time of registration until death due to any cause
Time Frame
From the time of registration until death, up to approximately 9 years
Title
Median Disease Free Survival
Description
The median amount of time measured from the time of registration until the time of disease recurrence or death.
Time Frame
From registration to disease recurrence or death, up to approximately 9 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lecia V. Sequist, MD, MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Massachusetts General Hosptial
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
North Shore Medical Center
City
Peabody
State/Province
Massachusetts
ZIP/Postal Code
01960
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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