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

NCT00567359 | Completed Phase 2 Results DMC

• 1 other identifier: 07-259
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 8

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.

Conditions

Non-small Cell Lung Cancer

Keywords

NSCLC; erlotinib; epidermal growth factor receptor; EGFR

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (3)

• Number of Participants With Treat Related Serious Adverse Events

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

• Median Overall Survival

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

• Median Disease Free Survival

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

Study Arms (1)

Erlotinib

EXPERIMENTAL

Drug: Erlotinib

Interventions

Erlotinib DRUG

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

Also known as: Tarceva

Erlotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Dana-Farber Cancer Institute: collaborator
• Genentech, Inc.: collaborator

Study Sites (8)

Stanford University

Stanford, California, 94305, United States

Location

Massachusetts General Hosptial

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

North Shore Medical Center

Peabody, Massachusetts, 01960, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Lecia Van Dam Sequist, M.D.
• Organization: Massachusetts General Hospital

LVSEQUIST@PARTNERS.ORG

617-724-4000

Study Officials

• Lecia V. Sequist, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 30, 2007
• First Posted: December 4, 2007
• Study Start: December 1, 2007
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 11, 2018
• Results First Posted: December 11, 2018

Record last verified: 2018-11

Locations

US (8)