A Study to Assess Biomarkers Impact on Participants Response to Erlotinib Treatment for First-line Non-Small Cell Lung Cancer With Endothelial Growth Factor Receptor (EGFR) Activating Mutations (BIOTEC)

Roche

Status and phase: Completed; Phase 2

Conditions: Carcinoma，Non-Small-Cell Lung

Treatments: Drug: Erlotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01153984

2009-017063-42

ML22606

Details and patient eligibility

About

This open-label, single-arm, multi-center study will evaluate the progression-free survival in participants with histologically documented, advanced and/or metastatic chemotherapy naive, non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) positive mutations and receiving erlotinib treatment. The anticipated time on study treatment is until disease progression, unacceptable toxicity, withdrawal due to any reason or death.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histological documented adenocarcinoma, locally advanced - Stage IIIB, metastatic - Stage IV or recurrent non-squamous NSCLC
• Activated EGFR mutation positive status (Exons 19 and 21) for treatment phase
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Life expectancy greater than or equal to (≥) 12 weeks
• Evidence of disease with at least one measurable disease evaluation on Response Evaluation Criteria in Solid Tumors (RECIST)
• Adequate hematological , liver and renal function

Exclusion criteria

• Known hypersensitivity to erlotinib or any of its excipients
• Squamous non-small cell or small cell tumors or absence of histological report
• Neoadjuvant/adjuvant chemotherapy within 6 months prior to enrollment
• Prior exposure to inhibitors of EGFR
• Prior chemotherapy or treatment with another systemic anti-cancer agent for the treatment of the participant's current stage of disease
• Any significant ophthalmologic abnormality, especially severe dry eye syndrome, keratoconjunctivitis sicca, Sjögren syndrome, severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions
• Radical radiotherapy with curative intent within 28 days prior to enrollment
• Any active non-controlled systemic disease

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Erlotinib

Experimental group

Description:

Participants will receive 150 milligrams (mg) erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.

Treatment:

Drug: Erlotinib