Status:
COMPLETED
Osimertinib Study in Indian Patients
Lead Sponsor:
AstraZeneca
Conditions:
Non Small Cell Lung Cancer (NSCLC)
Eligibility:
All Genders
18-99 years
Phase:
PHASE4
Brief Summary
This is a prospective, single-arm, multicenter, phase-IV study investigating the safety of osimertinib in Indian adult patients.
Detailed Description
This is a prospective, single-arm, multicenter, phase-IV trial investigating the safety of osimertinib in Indian adult patients with locally advanced or metastatic EGFR-T790M mutation-positive NSCLC. ...
Eligibility Criteria
Inclusion
- Patient of either gender and ≥18 years of age
- Patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an appropriate test, who have progressed on or after EGFR TKI therapy by an independent clinical judgment of treating physician based on locally approved prescribing information
- Each patient must sign an informed consent form (ICF)
Exclusion
- Patient with either the history of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug.
- Pregnant and/or lactating women
- Patients participating in any current or future interventional trial will not be enrolled in the current study
Key Trial Info
Start Date :
April 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03853551
Start Date
April 18 2019
End Date
April 15 2020
Last Update
June 3 2021
Active Locations (7)
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1
Research Site
Hyderabad, India, 500034
2
Research Site
Hyderabad, India, 500096
3
Research Site
Kolkata, India, 700160
4
Research Site
Mumbai, India, 400012