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

• ClinicalTrials.gov Identifier: NCT00567359
• Recruitment Status: Completed
• First Posted: December 4, 2007
• Results First Posted: December 11, 2018
• Last Update Posted: December 11, 2018
• Sponsor: Massachusetts General Hospital
• Collaborators: Dana-Farber Cancer Institute; Genentech, Inc.
• Information provided by (Responsible Party): Lecia V. Sequist, Massachusetts General Hospital

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.

Condition or disease	Intervention/treatment	Phase
Non-small Cell Lung Cancer	Drug: Erlotinib	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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)
• Study Start Date: December 2007
• Actual Primary Completion Date: December 2017
• Actual Study Completion Date: December 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Erlotinib	Drug: Erlotinib; Oral drug taken daily around the same time. Starting dose is 150mg once daily.; Other Name: Tarceva

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, California

Stanford University

Stanford, California, United States, 94305

United States, Massachusetts

Massachusetts General Hosptial

Boston, Massachusetts, United States, 02114

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02115

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02115

North Shore Medical Center

Peabody, Massachusetts, United States, 01960

United States, Missouri

Washington University School of Medicine

Saint Louis, Missouri, United States, 63110

United States, New York

Memorial Sloan Kettering Cancer Center

New York, 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

  Study Documents (Full-Text)

Documents provided by Lecia V. Sequist, Massachusetts General Hospital:

Study Protocol and Statistical Analysis Plan  [PDF] October 1, 2009

More Information

• Responsible Party: Lecia V. Sequist, Principal Investigator, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT00567359
• Other Study ID Numbers: 07-259
• First Posted: December 4, 2007
• Results First Posted: December 11, 2018
• Last Update Posted: December 11, 2018
• Last Verified: November 2018

Keywords provided by Lecia V. Sequist, Massachusetts General Hospital:

NSCLC; erlotinib; epidermal growth factor receptor; EGFR

Additional relevant MeSH terms:

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Erlotinib Hydrochloride; Antineoplastic Agents; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action