Real world study of lorlatinib in previously untreated ALK positive lung cancer
Not Applicable
- Conditions
- Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
- Registration Number
- CTRI/2024/03/063721
- Lead Sponsor
- Pfizer Products India Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients with histologically or cytologically confirmed diagnosis of locally advanced or metastatic (Stage IV) NSCLC with positive ALK-rearrangement
No prior systemic treatment for metastatic disease, however up to 2 cycles of chemotherapy are permitted.
Exclusion Criteria
Patients who fail to meet the predefined criteria for inclusion will be excluded from the
study
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) rate, Time Points- 18 monthsTimepoint: 18-months
- Secondary Outcome Measures
Name Time Method Estimation of overall survival (OS), PFS, objective response rate (ORR), intra-cranial ORR (IC-ORR), duration of response (DR, overall and intracranial duration of response), intracranial time to progression (for patients with and without brain metastases at diagnosis), Time to symptomatic response, PFS 2, Subsequent treatment and duration <br/ ><br>Safety (Including rates of dose interruption/dose reduction and treatment discontinuation), Frequency and nature of all-causality adverse events (AEs) <br/ ><br>To evaluate patient-reported outcomes (PROs) of health-related quality of life, disease/treatment-related symptoms of lung cancer, and general health status using EORTC QLQ C30 and LC13 questionnaires.Timepoint: Estimation of 18-months