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Report for Clinical Trial NCT03853551

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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).

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

NCT03853551 Non Small Cell Lung Cancer (NSCLC)
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

1 Interventions

Name: Osimertinib

Description: 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.
Type: Drug
Group Labels: 1

Single


Primary Outcomes

Description: Patient safety and adverse events will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE)

Measure: To assess the safety of osimertinib

Time: 5 months

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 T790M

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).. Osimertinib Study in Indian Patients This is a prospective, single-arm, multicenter, phase-IV study investigating the safety of osimertinib in Indian adult patients. --- T790M ---

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. --- T790M ---

2. Pregnant and/or lactating women 3. Patients participating in any current or future interventional trial will not be enrolled in the current study 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. --- T790M ---

2. Pregnant and/or lactating women 3. Patients participating in any current or future interventional trial will not be enrolled in the current study Non Small Cell Lung Cancer (NSCLC) Lung Neoplasms Carcinoma, Non-Small-Cell Lung 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. --- T790M ---

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. --- T790M ---

EGFR T790M positivity on plasma or tissue biopsy on PCR-based platform will be considered appropriate test. --- T790M ---

EGFR T790M must be performed after progressive disease on last line of therapy (on or after EGFR TKI therapy). --- T790M ---



HPO Nodes


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