A Study of Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (ESSENCE)

Roche

Status and phase: Completed; Phase 3

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: Erlotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01667562

ML27860

Details and patient eligibility

About

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.

Enrollment: 375 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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375 participants in 2 patient groups

Erlotinib

Experimental group

Description:

Erlotinib will be administered as a single daily oral dose of 150 milligrams until disease progression, death or unacceptable toxicity.

Treatment:

Drug: Erlotinib

Diagnostic Phase

No Intervention group

Description:

Participants with advanced or metastatic NSCLC were tested for EGFR mutations. Participants who did not have an EGFR mutation were excluded from the study.