Phase II, Open-label Study of Erlotinib (Tarceva®) Treatment in Patients With Locally Advanced, Metastatic or Recurrent Non-small Cell Lung Cancer Who Present Activating Mutations in the Tyrosine Kinase Domain of the Epidermal Growth Factor Receptor

Hoffmann-La Roche0 sites6 target enrollmentJanuary 2012

ConditionsNon-Squamous Non-Small Cell Lung Cancer

Interventionserlotinib [Tarceva]

Drugserlotinib [Tarceva]

Overview

Phase: Phase 2
Intervention: erlotinib [Tarceva]
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
Enrollment: 6
Primary Endpoint: Progression-free Survival (Tumour Assessments According to RECIST Criteria)
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This open-label study will assess the efficacy and safety of Tarceva (Erlotinib) in patients with locally advanced, metastatic or recurrent non-small cell lung cancer who have not received previous chemotherapy for their disease and who present epidermal growth factor receptor mutations. Patients will receive Tarceva 150 mg orally daily until disease progression or unacceptable toxicity occurs.

Registry

clinicaltrials.gov

Start Date

January 2012

End Date

January 2014

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult patients, \>/= 18 years of age
•Locally advanced (Stage IIIB), metastatic (Stage IV) or recurrent non-small cell lung cancer with mutations in the tyrosine kinase domain of the epidermal growth factor receptor (EGFR)
•At least one measurable lesion according to RECIST criteria
•European Cooperative Oncology Group (ECOG) performance status 0-2
•Adequate hematological, liver and renal function
•Patients with stable cerebral metastases who have received surgical or radiotherapy will be eligible

Exclusion Criteria

•Previous chemotherapy or therapy against EGFR for metastatic disease (neoadjuvant or adjuvant therapy after radical surgery is allowed if finalized \>/= 6 months before entering the study)
•History of another neoplasm except for carcinoma in situ of the cervix, adequately treated basal cell skin carcinoma, radically treated prostate carcinoma with good prognosis (Gleason \</= 6), or another curatively treated neoplasm without evidence of disease in the last 5 years
•Symptomatic cerebral metastases
•Any significant ophthalmologic abnormality
•Use of coumarins
•Pregnant or breast-feeding women
•Pre-existing parenchymal lung disease such as pulmonary fibrosis, lymphangiosis and carcinomatosis (if this is the only presence of the disease)

Arms & Interventions

Single Arm

Intervention: erlotinib [Tarceva]

Outcomes

Primary Outcomes

Progression-free Survival (Tumour Assessments According to RECIST Criteria)

Time Frame: Until participants had disease progression, unacceptable toxicity or died; approximately 24 months.

Progression free survival is (PFS) defined as the time from the first dose of Erlotinib to the date of first occurrence of disease progression or death.

Secondary Outcomes

Objective Response Rate (Investigator Assessed)(Visit 4, Visit 6, Visit 10 and Visit 22; (up to approximately 24 months))
Safety: Incidence of Adverse Events(Until participants had disease progression, unacceptable toxicity, or died; approximately 24 months.)
Overall Survival(Until participants had disease progression, unacceptable toxicity, or died; approximately 24 months.)