An Expanded Access Program of Tarceva (Erlotinib) in Participants With Advanced Non-Small Cell Lung Cancer (NSCLC)

Roche

Status and phase: Completed; Phase 4

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: Erlotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00949910

2004-000564-28 (EudraCT Number)

MO18109

INC-9042 (Other Identifier)

Details and patient eligibility

About

This study will provide treatment with erlotinib to participants with advanced NSCLC who have received at least one course of standard chemotherapy or radiation therapy, or who are not medically suitable for either. Efficacy and safety will be monitored throughout the study.

Enrollment: 6,586 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults greater than or equal to (≥) 18 years of age
• Histologically or cytologically documented inoperable, locally advanced, metastatic, or recurrent NSCLC
• Previous treatment with no more than 2 prior chemotherapy regimens

Exclusion criteria

• Previous systemic anti-cancer therapy with human epidermal growth factor receptor 1 (HER1)/epidermal growth factor receptor (EGFR) inhibitors
• Inability to take oral medication
• Any other malignancies within 5 years

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6,586 participants in 1 patient group

Erlotinib

Experimental group

Description:

Erlotinib will be given as a single agent in this expanded access program (EAP) to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Treatment will continue until unacceptable toxicity, disease progression, or withdrawal for any other reason.

Treatment:

Drug: Erlotinib