A prospective, multicentre study to see the safety of Osimertinib in Indian adult patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive nonsmall cell lung cancer.
- Conditions
- Health Condition 1: null- Metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive nonsmall cell lung cancer (NSCLC)Health Condition 2: C341- Malignant neoplasm of upper lobe,bronchus or lung
- Registration Number
- CTRI/2018/10/015941
- Lead Sponsor
- AstraZeneca Pharma India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
1 Patient of either sex 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 (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study. Patients must be willing and able to adhere to the prohibitions and restrictions specified in this protocol, as referenced in the informed consent form (ICF).
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
- Not specified
- Primary Outcome Measures
Name Time Method umber frequency and proportion of patients with adverse events (AEs) serious adverse events (SAEs) and AEs of special interest (AESI) including interstitial lung disease or pneumonitis like events and on study deathsTimepoint: NA
- Secondary Outcome Measures
Name Time Method ATimepoint: NA