Clinical trial NCT01667562: A Study of Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Official title: Phase IIIb, Open-Label Study of Erlotinib (Tarceva®) Treatment in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Present Activating Mutations in the Tyrosine Kinase Domain of the Epidermal Growth Factor Receptor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-08-17
Enrollment: 375
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This open-label, multi-center study will evaluate the progression-free survival and safety of erlotinib in participants with locally advanced or metastatic non-small cell lung cancer with activating mutations in the tyrosine kinase domain of the epidermal growth factor receptor (EGFR). Participants will receive daily oral doses of erlotinib until disease progression or unacceptable toxicity.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of locally advanced or metastatic non-small cell lung cancer with activating mutations in the tyrosine kinase domain of the EGFR
* Measurable disease according to RECIST
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Life expectancy greater than or equal to (\>/=) 12 weeks
* Adequate hematological, liver and renal function
* Participants with asymptomatic and stable cerebral metastases receiving medical treatment

Exclusion Criteria:

* Previous chemotherapy or treatment against EGFR for metastatic disease
* Treatment with an investigational agent less than 3 weeks before enrollment
* History of neoplasm other than non-small cell lung cancer (except carcinoma in situ of the uterine cervix, basal cell skin carcinoma, or prostate carcinoma)
* Participants with symptomatic cerebral metastases
* Any significant ophthalmologic abnormality
* Unstable systemic disease
* Coumarins use
* Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding contraindicating the use of an investigational drug
* Participants with pre-existing parenchymal lung disease such as pulmonary fibrosis, lymphangiosis carcinomatosis
* Participants with known infection with human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV)

Primary outcomes:
measure: Progression-Free Survival as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v 1.1)
timeFrame: Baseline until disease progression, or death, whichever occurs first (approximately up to 4 years and 9 months)
Secondary outcomes:
measure: Proportion of Participants With Objective Response as Assessed by RECIST v 1.1
timeFrame: Baseline until disease progression, or death, whichever occurs first (approximately up to 4 years and 9 months)
measure: Proportion of Participants With Disease Control as Assessed by RECIST v 1.1
timeFrame: Baseline until disease progression, or death, whichever occurs first (approximately up to 4 years and 9 months)
measure: Proportion of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations
timeFrame: Screening up to approximately 7 days
measure: Percentage of Participants With Adverse Events
timeFrame: Baseline up to approximately 4 years and 9 months
measure: Change From Baseline to End of Study in Quality of Life Score Using The Functional Assessment of Cancer Therapy Lung (FACT-L)
timeFrame: Baseline and end of study (approximately 4 years and 9 months)
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Clinic for Pulmonology, Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: Clinical Center Bezanijska Kosa; Oncology
city: Nis
country: Serbia
facility: Clinical Center Nis; Clinic for pulmonary diseases Knez Selo
city: Sremska Kamenica
country: Serbia
facility: Institute for pulmonary diseases of Vojvodina
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: