Trial Information

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

Status: Recruiting

Protocol Number: MO18109

Sponsor: F Hoffmann-La Roche Ltd/Inc/AG

Company Division: Pharmaceutical

Official Scientific Title: An open-label, expanded-access study of the effect of Tarceva on treatment response in patients with advanced stage IIIB/IV non-small-cell lung cancer

Brief Summary: This study will provide treatment with Tarceva to patients with advanced NSCLC who have received >=1 course of standard chemotherapy or radiation therapy, or who are not medically suitable for either. Efficacy and safety will be monitored throughout the study. The anticipated time on study treatment is as long as the patient is, in the investigator's opinion, benefiting from the therapy and the target sample size is 500+ individuals. Target sample size is 7041.

Study Phase: IV

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Non-Randomized
• Masking: Open Label
• Control: Uncontrolled
• Assignment: Single Group
• Endpoints: Safety/Efficacy

Study Type:

Condition: Non-Small Cell Lung Cancer

Intervention Type: Drug

Intervention Name: erlotinib[Tarceva]

Primary Outcome: 1. Patient access

Key Secondary Outcomes: 1. Efficacy: Response rate, time to progression, survival Safety: Serious adverse events, adverse events leading to premature withdrawal, rash related to therapy, laboratory assessments

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: November, 2004

Trial Registration Date: 06/24/2005

Date Last Updated: 06/17/2008

Link To Trial Results

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Trial listings updated: July 7, 2008 at 2:38:46 PM