Experience of Erlotinib in Patients With Advanced Non-Small Cell Lung Cancer (REALME)
An open-label, prospective, single-arm, multi-center phase IV clinical trial of TarcevaTM as single agent
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Real Life Experience of Erlotinib in Patients With Advanced Non-Small Cell Lung Cancer in the Middle Eastern Countries (REALME)|
- To evaluate the pattern of use of TarcevaTM in Middle Eastern patients with advanced NSCLC [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- To evaluate the activity and tolerability of TarcevaTM in this patient population [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
To evaluate the activity and tolerability of TarcevaTM in this patient population, assessing:
- Best response (as per investigator's assessment).
- Progression-Free Survival (PFS).
- Overall Survival (OS).
- Safety (Serious Adverse Events (SAEs), AEs leading to premature withdrawal, unexpected and expected TarcevaTM related AEs).
- To assess the degree of association (correlation) of EGFR expression rate (HER1) and other markers potentially predictive for response.
|Study Start Date:||October 2009|
|Estimated Study Completion Date:||October 2014|
|Estimated Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
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.
|King Abdul Aziz Medical City for National Guard Health Affairs||Recruiting|
|Riyadh, Saudi Arabia, 11426|
|Contact: Abdularahman Jazieh, MD,MPH 0096612520088 ext 14688 email@example.com|
|Contact: Oncology Research, Bsc. 0096612520088 ext 14601 firstname.lastname@example.org|
|Principal Investigator: Abdul Rahman Jazieh, MD<MPH|
|Principal Investigator:||Abdulrahman Jazieh, MD/MPH||King Abdul Aziz Medical City for National Guard|