Osimertinib Study in Indian Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03853551|
Recruitment Status : Completed
First Posted : February 25, 2019
Last Update Posted : August 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer (NSCLC)||Drug: Osimertinib||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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).|
|Actual Study Start Date :||April 18, 2019|
|Actual Primary Completion Date :||April 15, 2020|
|Actual Study Completion Date :||April 15, 2020|
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.
- To assess the safety of osimertinib [ Time Frame: 5 months ]Patient safety and adverse events will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03853551
|New Delhi, Delhi, India, 110029|
|New Delhi, Delhi, India, 110085|
|Mumbai, Maharashtra, India, 400012|
|Mumbai, Maharashtra, India, 400053|
|Hyderabad, Telangana, India, 500034|
|Hyderabad, Telangana, India, 500096|
|Kolkata, West Bengal, India, 7000160|