Phase 4
N=60
Osimertinib Study in Indian Patients
Non Small Cell Lung Cancer (NSCLC)
Bottom Line
View on ClinicalTrials.gov: NCT03853551 ↗Enrolled (actual)
60
Serious AEs
11.7%
Results posted
Jun 2021
Primary outcome: Primary: Safety of Osimertinib — 60 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Osimertinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety of Osimertinib |
60 | — |
Summary
This is a prospective, single-arm, multicenter, phase-IV study investigating the safety of osimertinib in Indian adult patients.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03853551). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.