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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01310036
First received: February 18, 2011
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This open-label, single arm study will evaluate the safety and efficacy of Tarce va (erlotinib) as first-line therapy in patients with stage IV or recurrent non- small cell lung cancer who harbour epidermal growth factor receptor (EGFR) mutat ions. All patients will receive Tarceva 150 mg daily orally until disease progre ssion or unacceptable toxicity occurs. At the investigator's discretion, patient s may receive Tarceva beyond disease progression.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Objective response rate (all patients and patients with EGFR mutation E19del or L858R) [ Time Frame: 42 months ] [ Designated as safety issue: No ]
  • Disease control rate (all patients and patients with EGFR mutation E19del or L858R) [ Time Frame: 42 months ] [ Designated as safety issue: No ]
  • Progression-free survival (patients with EGFR mutation E19del or L858R) [ Time Frame: 42 months ] [ Designated as safety issue: No ]
  • Overall survival (all patients and patients with EGFR mutation E19del or L858R) [ Time Frame: 42 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 42 months ] [ Designated as safety issue: No ]
  • Correlation between EGFR mutations in plasma and clinical outcome (ORR/PFS/OS) [ Time Frame: 42 months ] [ Designated as safety issue: No ]

Enrollment: 208
Study Start Date: April 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: erlotinib [Tarceva]
150 mg orally daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01310036

Locations
Hong Kong
Hong Kong, Hong Kong
Korea, Republic of
Gyeonggi-do, Korea, Republic of, 463-707
Incheon, Korea, Republic of, 405-760
Seoul, Korea, Republic of, 120-752
Seoul, Korea, Republic of, 137-701
Seoul, Korea, Republic of, 138-736
Seoul, Korea, Republic of, 135-170
Taiwan
Changhua, Taiwan, 500
Kaohsiung, Taiwan, 813
Kaohsiung, Taiwan, 00833
Taichung, Taiwan, 40447
Taichung, Taiwan, 407
Tainan, Taiwan, 704
Tainan, Taiwan, 710
Taipei, Taiwan
Taipei, Taiwan, 100
Taoyuan, Taiwan, 333
Thailand
Bangkok, Thailand, 10400
Songkhla, Thailand, 90110
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01310036     History of Changes
Other Study ID Numbers: ML25637
Study First Received: February 18, 2011
Last Updated: August 4, 2014
Health Authority: Korea: Korea FDA

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014