A Study of Erlotinib (Tarceva) in Participants With Non-Small Cell Lung Cancer (NSCLC) (MERIT)

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

NCT02774278

2004-005096-42 (EudraCT Number)

BO18279

Details and patient eligibility

About

This study will assess potentially predictive markers of efficacy in participants with NSCLC receiving oral erlotinib (Tarceva) therapy. The anticipated time on study treatment is until disease progression, unacceptable toxicity or death.

Enrollment: 264 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Advanced NSCLC
• Tumor accessible for biopsy by bronchoscopy
• Disease progression following course of standard chemotherapy, or participants unwilling/unable to undergo chemotherapy

Exclusion criteria

• Unstable systemic disease
• Any other malignancies in the last 5 years
• Brain metastases
• Previous treatment with therapy acting on the epidermal growth factor receptor (EGFR) axis

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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264 participants in 1 patient group

Erlotinib

Experimental group

Description:

Participants will receive erlotinib orally daily until disease progression, unacceptable toxicity or death.

Treatment:

Drug: Erlotinib