Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Intervention3: Nil: Nil
Intervention4: Nil: Nil
Intervention5: Nil: Nil
Control Intervention1: Nil: Nil
Sponsors
JSS AHER
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult patients aged 18 to 59 years with metastatic EGFR mutated non small cell lung cancer (NSCLC). 2. Patients receiving osimertinib as monotherapy at clinically relevant doses for a minimum of 14 days, sufficient to achieve steady-state plasma concentrations (based on an approximately 48 hour half life). 3. Patients who agree to participate in the study
Exclusion criteria
Exclusion criteria: 1. Individuals prescribed with the drugs known to interact with Osimertinib, especially CYP3A4 inhibitors or inducers, will be excluded from the study 2. Patients who do not agree to consent for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relationship between Osimertinib plasma exposure (Cmax / Cmin) and dose-limiting toxicity (DLT).Timepoint: Timepoints: 1. Baseline Prior toxicity status documented before PK sampling. 2. At PK sampling visits 6 hours post-dose (Cmax sampling visit) 24 hours post-dose (Cmin sampling visit) Adverse events recorded at these visits to link drug exposure with toxicity. 3. Continuous monitoring Toxicities recorded throughout the 3-month follow-up period after enrolment | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDr Karunanidhan
JSS College of Pharmacy
Outcome results
None listed