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

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00615758
• Other study ID #: CT/06.03
• Status: Completed
• Phase: Phase 2
• First received: February 1, 2008
• Last updated: December 14, 2009
• Start date: October 2006
• Est. completion date: November 2009

Study information

• Verified date: December 2009
• Source: Hellenic Oncology Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non Small Cell Lung Cancer

Intervention

Drug:
• Erlotinib
Erlotinib at the dose of 150 mg orally once a day continually until progression

Locations

Country	Name	City	State
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	Athens
Greece	"Diabalkaniko" Anticancer Hospital of Thessaloniki	Thessaloniki

Sponsors (2)

Lead Sponsor	Collaborator
Hellenic Oncology Research Group	University Hospital of Crete

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate		Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)	No
Secondary	Overall Survival		1-year OS	No
Secondary	Time to Tumor Progression		1 year TTP	No
Secondary	Quality of life assessment		Assessment every two cycles	No
Secondary	Toxicity assesment		Toxicity assessment on each cycles	Yes