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

Roche

Status and phase: Completed; Phase 2

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Treatments: Drug: Erlotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01310036

ML25637

Details and patient eligibility

About

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.

Enrollment: 208 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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208 participants in 1 patient group

Erlotinib

Experimental group

Description:

Erlotinib 150 mg daily

Treatment:

Drug: Erlotinib