Spots Global Cancer Trial Database for Osimertinib Study in Indian Patients

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Trial Identification

Brief Title: Osimertinib Study in Indian Patients

Official Title: 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).

Study ID: NCT03853551

Conditions

Non Small Cell Lung Cancer (NSCLC)

Interventions

Osimertinib

Study Description

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.