A Study of Tarceva (Erlotinib) as First Line Therapy in Participants With Non-Small Cell Lung Cancer Harbouring Epidermal Growth Factor Receptor (EGFR) Mutations

Hoffmann-La Roche208 enrolled

Overview

This open-label, single arm study will evaluate the safety and efficacy of Tarceva (erlotinib) as first-line therapy in participants with stage IV or recurrent non-small cell lung cancer who harbour epidermal growth factor receptor (EGFR) mutations. All participants will receive Tarceva 150 mg daily orally until disease progression or unacceptable toxicity occurs. At the investigator's discretion, participants may receive Tarceva beyond disease progression.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

208

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Interventions

Erlotinib

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult participants, \>/= 18 years of age * Stage IV or recurrent non-small cell lung cancer (NSCLC) * Presence of mutation(s) in exon 18 through exon 21 of epidermal growth factor receptor (EGFR), (except T790M single mutation only) * Measurable disease (at least one lesion \>= 10 mm in longest diameter) * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Adequate hematological, renal and liver function Exclusion Criteria: * Patients with T790M single mutation only * Prior exposure to agents directed at the human epidermal receptor (HER) axis, e.g. erlotinib, gefitinib, cetuximab, trastuzumab * Prior chemotherapy or systemic anti-cancer therapy for advanced NSCLC disease * Symptomatic or uncontrolled central nervous system (CNS) metastases * Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal or squamous cell carcinoma of the skin, or surgically treated localized prostate cancer, or surgically treated ductal cell carcinoma in situ of the breast * Any significant ophthalmologic abnormality * Pre-existing parenchymal lung disease such as pulmonary fibrosis * Use of coumarins (for anti-coagulation therapy the use of low molecular weight heparin is recommended instead)

Locations (22)

Princess Margaret Hospital; Oncology

Hong Kong, Hong Kong

Queen Elizabeth Hospital; Clinical Oncology

Hong Kong, Hong Kong

Prince of Wales Hosp; Dept. Of Clinical Onc

Shatin, Hong Kong

Seoul National University Bundang Hospital

Gyeonggi-do, South Korea

Gil Hospital. Gachon University

Incheon, South Korea

Asan Medical Center; Medical Oncology

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul St Mary's Hospital

Seoul, South Korea

Yonsei University Severance Hospital; Medical Oncology

Seoul, South Korea

Changhua Christian Hospital; Internal Medicine

Changhua, Taiwan

...and 12 more locations

Outcomes

Primary Outcomes

Progression-free Survival Per RECIST, v. 1.1 (PFS1)

PFS1 was defined as time from first dose until documented progressive disease (PD), assessed per Response Evaluation Criteria in Solid Tumors RECIST, v. 1.1, or death from any cause, whichever occurred first. PD was defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; and the appearance of one or more new lesions.