NCT02824952

Neo-adjuvant Trial With AZD9291 in EGFRm+ Stage IIIA/B NSCLC

Neo-adjuvant Trial With AZD9291 in EGFRm+ Stage IIIA/B NSCLC - a Phase 2 Open-label Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Shaare Zedek Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer, Non-small Cell

Interventions

Type	Name	Description
DRUG	Tagrisso	taking orally everyday for 6 or 12 weeks.

Timeline

• Start date: 2018-11-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2016-07-07
• Last updated: 2021-11-18

Locations

1 site across 1 country: Israel