NCT01320501

Experience of Erlotinib in Patients With Advanced Non-Small Cell Lung Cancer

Real Life Experience of Erlotinib in Patients With Advanced Non-Small Cell Lung Cancer in the Middle Eastern Countries (REALME)

• Status: Suspended
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: National Guard Health Affairs · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An open-label, prospective, single-arm, multi-center phase IV clinical trial of TarcevaTM as single agent

Detailed description

Advanced NSCLC remains largely fatal, with the positive impact of chemotherapy limited by intrinsic and acquired resistance, manifested clinically by early progression and transient responses. Current chemotherapy regimens have limited efficacy with a magnitude of survival benefit that is still modest, and lead to significant toxicity, with many patients unable to receive this kind of treatment, even in first line setting. There is, therefore, a great need to provide patients with less toxic agents such as the novel targeted therapies, with the potential to improve the efficacy and maintain a good quality of life with little associated toxicity. TarcevaTM has shown benefit as single agent in pretreated patients who have progressed despite platinum-based chemotherapy as summarized in section 1.2 with minimal toxicity compared to chemotherapy, and also is currently assessed as first line treatment in advanced NSCLC with promising preliminary efficacy results. As previously described, TarcevaTM has recently been shown to prolong survival in a large, randomized, placebo-controlled Phase III trial including 731 NSCLC patients no longer candidates for further chemotherapy. This is the first and so far the only evidence of definitive clinical benefit provided by an EGFR inhibitor in cancer patients. TarcevaTM is the standard of care for second and third line treatment for lung cancer in USA and Europe. However, the experience with this agent in the Middle Eastern population is very limited. The rationale for this program is to evaluate the pattern of TarcevaTM use in patients with advanced (inoperable stage III or IV) NSCLC who have failed standard treatment, or patients who can not receive other systemic anticancer therapy, or patients who are not medically suitable for chemotherapy (e.g., poor performance status). This will also enable us to study the efficacy and safety of TarcevaTM in this population, as there may be differences in the pharmacogenomic of this population and the previously studied population.

Conditions

• Non-small Cell Lung Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Erlotinib	All patients will receive: TarcevaTM 150mg/day PO.

Timeline

• Start date: 2009-10-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2011-03-22
• Last updated: 2016-05-13

Locations

1 site across 1 country: Saudi Arabia