Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer
Treatment erlotinib
Phase phase 3
Sponsor Hoffmann-La Roche
Start date January 2012
End date June 2017
Trial size 30 participants
Trial identifier NCT01667562, ML27860

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Primary purpose treatment
Masking no masking
Arm
(Experimental)
Erlotinib will be administered as a single daily oral dose of 150 milligrams until disease progression, death or unacceptable toxicity.
erlotinib Tarceva
Daily oral doses administered until disease progression or unacceptable toxicity or death.

Primary Outcomes

Measure
Progression-Free Survival as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v 1.1)
time frame: Baseline until disease progression, or death, whichever occurs first (approximately up to 4 years and 9 months)

Secondary Outcomes

Measure
Percentage of Participants with Objective Response as Assessed by RECIST v 1.1
time frame: Baseline until disease progression, or death, whichever occurs first (approximately up to 4 years and 9 months)
Percentage of Participants with Disease Control as Assessed by RECIST v 1.1
time frame: Baseline until disease progression, or death, whichever occurs first (approximately up to 4 years and 9 months)
Percentage of Participants With EGFR Mutations
time frame: Screening up to approximately up to 4 years and 9 months
Percentage of Participants with Adverse Events or Serious Adverse Events
time frame: Baseline up to approximately 4 years and 9 months
Change From Baseline in Quality of Life Score Using The Functional Assessment of Cancer Therapy Lung (FACT-L) at every 6 Week
time frame: Baseline, at every 6 week until disease progression, death or unacceptable toxicity, or end of treatment (whichever occurs first) (approximately 4 years and 9 months)

Eligibility Criteria

All participants at least 18 years old.

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)

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in March 2017.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.