Osimertinib Study in Indian Patients

• Status: Completed
• Trial end date: 2020-04-15
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, single-arm, multicenter, phase-IV study investigating the safety of osimertinib in Indian adult patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Osimertinib

Criteria

Inclusion Criteria:

1. Patient of either gender and ≥18 years of age

2. 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

3. Each patient must sign an informed consent form (ICF)

Exclusion Criteria:

1. 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.

2. Pregnant and/or lactating women

3. Patients participating in any current or future interventional trial will not be enrolled in the current study