Overview

This trial is active, not recruiting.

Condition non-squamous non-small cell lung cancer
Treatment erlotinib [tarceva]
Phase phase 3
Sponsor Hoffmann-La Roche
Start date January 2012
End date October 2016
Trial size 12 participants
Trial identifier NCT01667562, ML27860

Summary

This open-label, multi-center study will evaluate the progression-free survival and safety of Tarceva (erlotinib) in patients 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). Patients will receive daily oral doses of Tarceva until disease progression or unacceptable toxicity.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
erlotinib [tarceva]
Daily oral doses of 150 mg administered until disease progression or unacceptable toxicity

Primary Outcomes

Measure
Progression-free survival
time frame: Approximately 2 years

Secondary Outcomes

Measure
Response rate
time frame: Approximately 2 years
Safety: incidence of adverse events
time frame: Approximately 2 years
Incidence of epidermal growth factor receptor mutations in patients
time frame: Approximately 2 years
Quality of life
time frame: Approximately 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Adult patients, >/= 18 years of age - Diagnosis of locally advanced or metastatic non-small cell lung cancer with activating mutations in the tyrosine kinase domain of the epidermal growth factor receptor (EGFR) - Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - Life expectancy >/=12 weeks - Adequate hematological, liver and renal function Exclusion Criteria: - Previous chemotherapy or treatment against EGFR for metastatic disease - Treatment with an investigational agent less than 3 weeks before enrolment - 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) - Patients with symptomatic cerebral metastases - Any significant ophthalmologic abnormality - Unstable systemic disease

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 (ESSENCE)
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.