Osimertinib Study in Indian Patients

About this trial

Last updated 5 years ago

Study ID

D5161C00005

Status

Completed

Type

Interventional

Phase

Phase 4

Placebo

Accepting

18 to 99 Years

All Sexes

Trial Timing

Ended 6 years ago

What is this trial about?

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

What are the participation requirements?

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