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A Study of Tarceva (Erlotinib) as First Line Therapy in Patients With Non-Small Cell Lung Cancer Harbouring Epidermal Growth Factor Receptor (EGFR) Mutations

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01310036
First Posted: March 7, 2011
Last Update Posted: May 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
This open-label, single arm study will evaluate the safety and efficacy of Tarceva (erlotinib) as first-line therapy in patients with stage IV or recurrent non-small cell lung cancer who harbour epidermal growth factor receptor (EGFR) mutations. All patients will receive Tarceva 150 mg daily orally until disease progression or unacceptable toxicity occurs. At the investigator's discretion, patients may receive Tarceva beyond disease progression.

Condition Intervention Phase
Non-Squamous Non-Small Cell Lung Cancer Drug: erlotinib [Tarceva] Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Multi-center Study of Erlotinib (Tarceva®) as First Line Therapy Until and Beyond Disease Progression in NSCLC Patients Who Harbour EGFR Mutations

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival by RECIST (PFS1), defined as time from first dose until documented RECIST disease progression or death of any cause at any time, whichever occurs first [ Time Frame: 42 months ]

Secondary Outcome Measures:
  • Progression-free survival by investigator's discretion (PFS2), defined as time from first study dose to off-Tarceva PD assessed by investigator based on overall clinical evaluation not limited to RECIST [ Time Frame: 42 months ]
  • Objective response rate (all patients and patients with EGFR mutation E19del or L858R) [ Time Frame: 42 months ]
  • Disease control rate (all patients and patients with EGFR mutation E19del or L858R) [ Time Frame: 42 months ]
  • Progression-free survival (patients with EGFR mutation E19del or L858R) [ Time Frame: 42 months ]
  • Overall survival (all patients and patients with EGFR mutation E19del or L858R) [ Time Frame: 42 months ]
  • Safety: Incidence of adverse events [ Time Frame: 42 months ]
  • Correlation between EGFR mutations in plasma and clinical outcome (ORR/PFS/OS) [ Time Frame: 42 months ]

Enrollment: 208
Actual Study Start Date: April 30, 2011
Study Completion Date: December 30, 2016
Primary Completion Date: December 30, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: erlotinib [Tarceva]
150 mg orally daily

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Stage IV or recurrent non-small cell lung cancer (NSCLC)
  • Presence of mutation(s) in exon 18 through exon 21 of epidermal growth factor receptor (EGFR), (except T790M single mutation only)
  • Measurable disease (at least one lesion >= 10 mm in longest diameter)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Adequate hematological, renal and liver function

Exclusion Criteria:

  • Patients with T790M single mutation only
  • Prior exposure to agents directed at the human epidermal receptor (HER) axis, e.g. erlotinib, gefitinib, cetuximab, trastuzumab
  • Prior chemotherapy or systemic anti-cancer therapy for advanced NSCLC disease
  • Symptomatic or uncontrolled central nervous system (CNS) metastases
  • Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal or squamous cell carcinoma of the skin, or surgically treated localized prostate cancer, or surgically treated ductal cell carcinoma in situ of the breast
  • Any significant ophthalmologic abnormality
  • Pre-existing parenchymal lung disease such as pulmonary fibrosis
  • Use of coumarins (for anti-coagulation therapy the use of low molecular weight heparin is recommended instead)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01310036


Locations
Hong Kong
Princess Margaret Hospital; Oncology
Hong Kong, Hong Kong
Queen Elizabeth Hospital; Clinical Oncology
Hong Kong, Hong Kong
Prince of Wales Hosp; Dept. Of Clinical Onc
Shatin, Hong Kong
Korea, Republic of
Seoul National University Bundang Hospital
Gyeonggi-do, Korea, Republic of, 13620
Gil Hospital. Gachon University
Incheon, Korea, Republic of, 405-760
Asan Medical Center; Medical Oncology
Seoul, Korea, Republic of, 05505
Samsung Medical Center
Seoul, Korea, Republic of, 06351
Seoul St Mary's Hospital
Seoul, Korea, Republic of, 06591
Yonsei University Severance Hospital; Medical Oncology
Seoul, Korea, Republic of, 120-752
Taiwan
Changhua Christian Hospital; Internal Medicine
Changhua, Taiwan, 500
Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine
Kaohsiung, Taiwan, 00833
Veterans General Hospital; Internal Medicine
Kaohsiung, Taiwan, 813
China Medical University Hospital; Pulmonary and Critical Care Medicine
Taichung, Taiwan, 40447
Taichung Veterans General Hospital; Dept of Internal Medicine
Taichung, Taiwan, 407
National Cheng Kung Uni Hospital; Dept of Hematology and Oncology
Tainan, Taiwan, 704
Chi-Mei Medical Centre; Hematology & Oncology
Tainan, Taiwan, 710
National Taiwan Uni Hospital; Internal Medicine
Taipei, Taiwan, 100
Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology
Taipei, Taiwan, 112
Chang Gung Medical Foundation - Linkou; Chest Dept
Taoyuan, Taiwan, 333
Thailand
Chulalongkorn Hospital; Medical Oncology
Bangkok, Thailand, 10330
Pramongkutklao Hospital; Medicine - Medical Oncology Unit
Bangkok, Thailand, 10400
Songklanagarind Hospital; Department of Internal Medicine, Division of Respiratory
Songkhla, Thailand, 90110
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01310036     History of Changes
Other Study ID Numbers: ML25637
First Submitted: February 18, 2011
First Posted: March 7, 2011
Last Update Posted: May 18, 2017
Last Verified: May 2017

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