Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
Conditions
Interventions
Control Intervention1: NIL: NIL
Sponsors
Pfizer Products India Private Limited
Eligibility
Inclusion criteria
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
Exclusion criteria: Patients who fail to meet the predefined criteria for inclusion will be excluded from the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS) rate, Time Points- 18 monthsTimepoint: 18-months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 Safety (Including rates of dose interruption/dose reduction and treatment discontinuation), Frequency and nature of all-causality adverse events (AEs) 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 | — |
Countries
India
Contacts
Public ContactDr Harish Thanusubramanian
Pfizer Products India Private Limited
Outcome results
None listed