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.
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: February 18, 2011
Last updated: April 2, 2016
Last verified: April 2016
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
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 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: erlotinib [Tarceva]
150 mg orally daily


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

Hong Kong
Hong Kong, Hong Kong, 852
Hong Kong, Hong Kong
Shatin, Hong Kong
Korea, Republic of
Gyeonggi-do, Korea, Republic of, 13620
Incheon, Korea, Republic of, 405-760
Seoul, Korea, Republic of, 05505
Seoul, Korea, Republic of, 06351
Seoul, Korea, Republic of, 06591
Seoul, Korea, Republic of, 120-752
Changhua, Taiwan, 500
Kaohsiung, Taiwan, 00833
Kaohsiung, Taiwan, 813
Taichung, Taiwan, 407
Taichung, Taiwan, 40447
Tainan, Taiwan, 704
Tainan, Taiwan, 710
Taipei, Taiwan, 100
Taipei, Taiwan
Taoyuan, Taiwan, 333
Bangkok, Thailand, 10330
Bangkok, Thailand, 10400
Songkhla, Thailand, 90110
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

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: April 2, 2016
Health Authority: Korea: Korea FDA

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

ClinicalTrials.gov processed this record on May 03, 2016