A Study of Tarceva (Erlotinib) in Patients With Advanced and/or Metastatic Non-small Cell Lung Cancer With EGFR Positive Mutation (BIOTEC)

Non-Squamous Non-Small Cell Lung Cancer Clinical Trial

Official title:

Biomarkers Impact On the Response to Treatment With Erlotinib in First Line Non-small Cell Lung Cancer With EGFR Positive Mutation - BIOTEC

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01153984
• Other study ID #: ML22606
• Secondary ID: 2009-017063-42
• Status: Completed
• Phase: Phase 2
• First received: June 16, 2010
• Last updated: August 1, 2016
• Start date: June 2011
• Est. completion date: July 2015

Study information

• Verified date: August 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: National Medicines Agency
• Study type: Interventional

Clinical Trial Summary

This open-label, single-arm, multi-center study will evaluate the effect of Tarceva (erlotinib) on progression-free survival and the incidence and type of biomarkers in patients with advanced and/or metastatic non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) positive mutations. Eligible patients will receive Tarceva 150mg po daily. The anticipated time on study treatment is until progression or unacceptable toxicity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >=18 years of age

• Histological documented adenocarcinoma, locally advanced - stage IIIB, metastatic - stage IV or recurrent non-squamous non-small cell lung cancer (NSCLC)

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1

• Life expectancy >=12 weeks

• Evidence of disease with at least one measurable disease criteria as evaluated by Response Evaluation Criteria in Solid Tumors (RECIST)

• Adequate haematological, liver and renal function

Exclusion Criteria:

• Known hypersensitivity to erlotinib or any of its excipients

• Squamous non-small cell or small cell tumors or absence of histological report

• Neoadjuvant/adjuvant chemotherapy within 6 months prior to enrolment

• Prior exposure to inhibitors of Epidermal Growth Factor Receptor (EGFR)

• Prior chemotherapy or treatment with another systemic anti-cancer agent for the treatment of the patient's current stage of disease

• Any significant ophthalmologic abnormality, especially severe dry eye syndrome, keratoconjunctivitis sicca, Sjögrens syndrome, severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions

• Radical radiotherapy with curative intent within 28 days prior to enrolment

• Any active non-controlled systemic disease

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• erlotinib [Tarceva]
erlotinib [Tarceva] 150mg po daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of progression-free survival by Eastern Cooperative Oncology Group (ECOG) performance status and Response Evaluation Criteria in Solid Tumors (RECIST)		From baseline until 40 months	No
Secondary	Evaluation of time to disease progression by Eastern Cooperative Oncology Group (ECOG) performance status and Response Evaluation Criteria in Solid Tumors (RECIST)		From baseline up to 40 months	No
Secondary	Evaluation of objective response rate by Eastern Cooperative Oncology Group (ECOG) performance status and Response Evaluation Criteria in Solid Tumors (RECIST)		From baseline up to 40 months	No
Secondary	Evaluation of 1-year survival rate by Eastern Cooperative Oncology Group (ECOG) performance status and Response Evaluation Criteria in Solid Tumors (RECIST)		From baseline up to 40 months	No
Secondary	Assessment of the localization of disease progression by Eastern Cooperative Oncology Group (ECOG) performance status and Response Evaluation Criteria in Solid Tumors (RECIST)		From baseline up to 40 months	No
Secondary	Evaluation of patient's profile based on gender, age, incidence of mutations, smoking status		From baseline up to 40 months	No
Secondary	Collection of local epidemiological data		At Screening (prior to Day-14) and at Baseline (Day-14 to -1)	No