At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 60 enrolled
Drug / intervention
Osimertinibdrug
Likely dose
Not stated in record
Key inclusion· 4
- ✓Metastatic EGFR T790M mutation-positive NSCLC confirmed by appropriate testing
- ✓Disease progression on or after prior EGFR TKI therapy by independent clinical judgment
- ✓Age ≥18 years
- ✓Signed informed consent form
Key exclusion· 3
- ✕History of hypersensitivity to osimertinib excipients or chemically similar drugs
- ✕Pregnant or lactating women
- ✕Concurrent participation in other interventional trials
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Multicenter, Phase-IV Clinical Trial to Assess Safety of Osimertinib in Indian Adult Patients With Metastatic Epidermal Growth Factor Receptor (EGFR) T790M Mutation-positive Non-small Cell Lung Cancer (NSCLC).
In Brief
A Phase 4 clinical trial evaluating Osimertinib for Non Small Cell Lung Cancer (NSCLC). Completed, enrolled 60 participants across 7 sites.
Detailed Summary
This is a prospective, single-arm, multicenter, phase-IV study investigating the safety of osimertinib in Indian adult patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon Small Cell Lung Cancer (NSCLC)
CountriesIndia
Collaborators--
Timeline
Phase 4CompletedFinished
20192020202120222023202420252026
First PostedFeb 2019
Enrollment StartApr 2019
Primary CompletionApr 2020
TodayJul 2026
First PostedFeb 25, 2019
Enrollment StartApr 18, 2019
Primary CompletionApr 15, 2020
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 7.4 years ago
Interventions
Osimertinibdrug
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.