Osimertinib Study in Indian Patients

Phase 4

Completed

• Conditions: Non Small Cell Lung Cancer (NSCLC)
• Interventions: Drug: Osimertinib

• Registration Number: NCT03853551
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

This is a prospective, single-arm, multicenter, phase-IV trial investigating the safety of osimertinib in Indian adult patients with locally advanced or metastatic EGFR-T790M mutation-positive NSCLC.

Prior to data collection, all patients must sign an informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements and sponsor policy.

Patients with metastatic EGFR T790M mutation-positive NSCLC, who are eligible to osimertinib treatment as per locally approved prescribing information and ratified by an independent clinical judgment of treating physician will be evaluated for the inclusion into the current phase-IV study based on eligibility criteria. EGFR T790M positivity on plasma or tissue biopsy on PCR-based platform will be considered appropriate test. EGFR T790M must be performed after progressive disease on last line of therapy (on or after EGFR TKI therapy). In order to enroll approximately 60 patients, it is expected that approximately 70 patients will be screened.

Study Timeline

• Study First Submitted: 2019-02-20
• Study First Submitted QC: 2019-02-22
• Study First Posted: 2019-02-25
• Study Start: 2019-04-18
• Primary Completion: 2020-04-15
• Study Completion: 2020-04-15
• Results First Submitted: 2021-03-31
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-10
• Last Update Submitted: 2021-05-10
• Results First Posted: 2021-06-03
• Last Update Posted: 2021-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single	Osimertinib	Single arm

Primary Outcome Measures

Name	Time	Method
Safety of Osimertinib	5 months	Number of Patients with treatment emergent Adverse Events

Trial Locations

Locations (1)

Research Site; 🇮🇳 New Delhi, India