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

ERLOTINIB, A TYROSINE KINASE INHIBITOR OF EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) AS FIRST LINE TREATMENT, IN PATIENTS WITH LOCALLY ADVANCED/METASTATIC NON SMALL CELL LUNG CANCER (NSCLC). A PHASE II STUDY

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

Study Overview

• Status: Completed
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Drug: Erlotinib

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
• Enrollment (Anticipated): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece
    • 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
  • Thessaloniki, Greece
    • "Diabalkaniko" Anticancer Hospital of Thessaloniki

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Tarceva	Drug: Erlotinib; Erlotinib at the dose of 150 mg orally once a day continually until progression; Other Names: Tarceva

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall Response Rate	Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)

Secondary Outcome Measures

Outcome Measure	Time Frame
Quality of life assessment	Assessment every two cycles
Time to Tumor Progression	1 year TTP
Overall Survival	1-year OS
Toxicity assesment	Toxicity assessment on each cycles

Collaborators and Investigators

• Sponsor: Hellenic Oncology Research Group
• Collaborators: University Hospital of Crete
• Investigators: Principal Investigator: Vassilis Georgoulias, MD, University Hospital of Crete; Principal Investigator: Athanasios Pallis, MD, University Hospital of Crete

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: February 1, 2008
• First Submitted That Met QC Criteria: February 1, 2008
• First Posted (Estimate): February 14, 2008

Study Record Updates

• Last Update Posted (Estimate): December 15, 2009
• Last Update Submitted That Met QC Criteria: December 14, 2009
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: Erlotinib; Biological therapy; Tyrosin Kinase Inhibitor therapy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Erlotinib Hydrochloride
• Other Study ID Numbers: CT/06.03