Erlotinib as 1st Line Treatment in NSCLC Stage IIIB/IV

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. Identifier: NCT00615758
Recruitment Status : Completed
First Posted : February 14, 2008
Last Update Posted : December 15, 2009
University Hospital of Crete
Information provided by:
Hellenic Oncology Research Group

Brief Summary:
To evaluate the efficacy and toxicity of erlotinib as first line treatment in patients with locally advanced/metastatic (stages IIIB/IV) NSCLC, with clinical predictors of response to tyrosine kinase inhibitors (erlotinib, gefitinib), such as female gender, never-smoking status and adenocarcinoma histology. Furthermore, erlotinib-sensitivity will be correlated with the presence of EGFR mutations in exons 18, 19 and 21, in this population

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: Erlotinib Phase 2

Detailed Description:
A randomized, placebo-controlled phase III trial of erlotinib versus placebo, with more than 700 patients demonstrated that therapy with this tyrosine kinase inhibitor (TKI) prolongs survival after first or second line therapy in patients with advanced NSCLC. Statistically significant and clinically relevant differences were observed for overall and progression free survival in favour of erlotinib. Moreover, several clinical factors had been correlated with response to gefitinib or erlotinib, including never smoking status, female gender, Asian ethnicity and adenocarcinoma histology (especially bronchioalveolar carcinoma).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2006
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Drug: Erlotinib
Erlotinib at the dose of 150 mg orally once a day continually until progression
Other Name: Tarceva

Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) ]

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 1-year OS ]
  2. Time to Tumor Progression [ Time Frame: 1 year TTP ]
  3. Quality of life assessment [ Time Frame: Assessment every two cycles ]
  4. Toxicity assesment [ Time Frame: Toxicity assessment on each cycles ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically or cytologically confirmed, unresectable locally advanced (stage IIIB with pleural effusion) and/or metastatic (stage IV) NSCLC
  • No previous therapy for advanced/metastatic NSCLC is allowed
  • age >18 years
  • bidimensionally measurable disease
  • non-smokers (or ex-smokers with less than 5 pack-years smoking history)
  • adenocarcinoma histology
  • performance status (WHO) 0-3
  • adequate liver (serum bilirubin <1.5 times the upper normal limit (UNL); AST and ALT <2.5 times the UNL in the absence of demonstrable liver metastases, or <5 times the UNL in the presence of liver metastases); adequate renal function (serum creatinine <1.5 times the UNL); and bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) function
  • previous radiotherapy, either in the adjuvant setting or for the treatment of metastatic disease is allowed provided that the measurable lesions are outside the radiation fields
  • patient able to take oral medication
  • tissue sample for tumour mutational analysis is required

Exclusion Criteria:

  • serious chronic skin conditions (e.g. psoriasis, eczema) that would preclude study participation
  • active infection
  • history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
  • malnutrition (loss of ≥ 20% of the original body weight)
  • performance status: 4
  • psychiatric illness or social situation that would preclude study compliance
  • pregnant or lactating women

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 identifier (NCT number): NCT00615758

401 Military Hospital, Medical Oncology Unit
Athens, Greece
Air Forces Military Hospital, Dep of Medical Oncology
Athens, Greece
IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens, Greece
Sotiria" General Hospital, 2nd Dep of Pulmonary Diseases
Athens, Greece
"Diabalkaniko" Anticancer Hospital of Thessaloniki
Thessaloniki, Greece
Sponsors and Collaborators
Hellenic Oncology Research Group
University Hospital of Crete
Principal Investigator: Vassilis Georgoulias, MD University Hospital of Crete
Principal Investigator: Athanasios Pallis, MD University Hospital of Crete

Responsible Party: V.Georgoulias, Hellenic Oncology Research Group Identifier: NCT00615758     History of Changes
Other Study ID Numbers: CT/06.03
First Posted: February 14, 2008    Key Record Dates
Last Update Posted: December 15, 2009
Last Verified: December 2009

Keywords provided by Hellenic Oncology Research Group:
Biological therapy
Tyrosin Kinase Inhibitor therapy

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