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A Study of Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Mutations

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01260181
First received: December 13, 2010
Last updated: August 22, 2017
Last verified: August 2017
  Purpose
This single arm, open-label study will evaluate the efficacy and safety of erlotinib (Tarceva) in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations.

Condition Intervention Phase
Non-Squamous Non-Small Cell Lung Cancer Drug: Erlotinib Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II, Open-Label Study of Erlotinib (Tarceva®) Treatment in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Present Activating Mutations in the Tyrosine Kinase Domain of the Epidermal Growth Factor Receptor

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants with Objective Response (Complete Response [CR]/Partial Response [PR]) Based on Computer Tomography (CT) or Magnetic Resonance Imaging (MRI) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 [ Time Frame: Baseline up to 5 years (assessed at Baseline, every 8 weeks until disease progression or death or end of treatment period [up to 5 years]) ]

Secondary Outcome Measures:
  • Progression Free Survival (PFS) Based on CT or MRI According to RECIST v 1.1 [ Time Frame: Baseline up to 5 years (assessed at Baseline, every 8 weeks until disease progression or death or end of treatment period [up to 5 years]) ]
  • Overall Survival [ Time Frame: Baseline up to 5 years ]
  • Percentage of Participants with Adverse Events [ Time Frame: Baseline up to 5 years ]
  • Percentage of Participants with Epidermal Growth Factor Receptor (EGFR) Mutation in Study Population [ Time Frame: Screening (21 days prior to Day 1) ]
  • Median Time Taken for the First Response Based on RECIST v 1.1 as Determined by the Investigator [ Time Frame: Baseline up to 5 years (assessed at Baseline, every 8 weeks until disease progression or death or end of treatment period [up to 5 years]) ]

Enrollment: 30
Actual Study Start Date: March 31, 2011
Estimated Study Completion Date: December 31, 2018
Estimated Primary Completion Date: December 31, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Erlotinib
Participants will receive erlotinib 150 millgrams (mg) orally daily until disease progression.
Drug: Erlotinib
Erlotinib 150 mg tablet will be given orally daily.

  Eligibility

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

Inclusion Criteria:

  • Locally advanced or metastatic NSCLC with EGFR mutations
  • Measurable disease according to RECIST criteria
  • Adequate hematological, renal and liver function

Exclusion Criteria:

  • Previous chemotherapy or therapy against EGFR for metastatic disease
  • Symptomatic cerebral metastases
  • Pre-existing disease of the lung parenchyma such as lung fibrosis, lymphangitic carcinomatosis
  • History of another malignancy except for carcinoma in-situ of the cervix, adequately treated basal cell skin carcinoma, or radically treated prostate carcinoma with good prognosis
  • Concomitant use of coumarins
  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: NCT01260181

Locations
Portugal
Hospital Infante D. Pedro; Servico de Oncologia Medica
Aveiro, Portugal, 3814-501
Hospital Geral; Servico de Pneumologia
Coimbra, Portugal, 3041-801
IPO de Lisboa; Servico de Pneumologia
Lisboa, Portugal, 1099-023
Hospital Santo Antonio dos Capuchos;Servico de Oncologia Medica
Lisboa, Portugal, 1150-314
Hospital de Santa Maria; Servico de Pneumologia
Lisboa, Portugal, 1600
Hospital Pulido Valente; Servico de Pneumologia
Lisboa, Portugal, 1796-001
IPO do Porto; Servico de Oncologia Medica
Porto, Portugal, 4200-072
Hospital de Sao Joao; Servico de Pneumologia
Porto, Portugal, 4200
CHVNG/E_Unidade 1; Servico de Pneumologia
Vila Nova De Gaia, Portugal, 4434-502
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01260181     History of Changes
Other Study ID Numbers: ML25434
2010-022509-17
Study First Received: December 13, 2010
Last Updated: August 22, 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
Mitogens
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Mitosis Modulators

ClinicalTrials.gov processed this record on September 21, 2017