Osimertinib Study in Indian Patients

Sponsor
AstraZeneca
Study ID
NCT03853551
Phase
PHASE4
Status
Completed

Conditions

  • Non Small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Osimertinib — DRUG
    Osimertinib is an oral, potent, selective, irreversible inhibitor of both epidermal growth factor receptor - Tyrosine kinase inhibitors (EGFR-TKI) sensitizing and resistance mutations in nonsmall cell lung cancer (NSCLC) with a significant selectivity margin over wild-type EGFR.

Study Details

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

Key Dates

Start date
Apr 18, 2019
Status verified
May 2021
Primary completion
Apr 15, 2020
Completion
Apr 15, 2020

Study Design

Enrollment
60 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single
    Single arm

Primary Outcome Measure

Safety of Osimertinib [ Time Frame: 5 months ]

Related Studies