Neo-adjuvant Trial With AZD9291 in EGFRm+ Stage IIIA/B NSCLC
- Registration Number
- NCT02824952
- Lead Sponsor
- Shaare Zedek Medical Center
- Brief Summary
Patients will receive AZD9291 at a dose of 80 mg once daily. Systemic evaluation will be done by PET-CT scan after 6 weeks.
In responding patients AZD9291 will be given orally 80 mg daily for 12 weeks. Non-responding patients will receive AZD9291 for the period of 6 or 12 weeks (according to the results of response assessment at each time-point).
- Detailed Description
Patients will receive AZD9291 at a dose of 80 mg once daily. Systemic evaluation will be done by PET-CT scan after 6 weeks.
In responding patients AZD9291 will be given orally 80 mg daily for 12 weeks. Non-responding patients will receive AZD9291 for the period of 6 or 12 weeks (according to the results of response assessment at each time-point). All the patients will be followed for 2 years.
The imaging modality used for RECIST v1.1 assessments will be PET-CT scan.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Tagrisso 80 mg Tagrisso 80 mg of Tagrisso(AZD9291) will be given every day for 6 or 12 weeks.
- Primary Outcome Measures
Name Time Method Overall Response Rate as defined by RECIST 1.1 12 weeks assessed by PET-CT
- Secondary Outcome Measures
Name Time Method Comparing GTV (Gross tumor volume) before and after the neoadjuvant therapy 2 years Comparing GTV (Gross tumor volume) before and after the neoadjuvant therapy
mPFS measured by Kaplan-Meier method. 2 years mPFS measured by Kaplan-Meier method.
Trial Locations
- Locations (1)
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Shaare Zedek Medical Center🇮🇱Jerusalem, IsraelNir Peled, MD PhD FCCPContactnirp@szmc.org.il