Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
Conditions
Interventions
None listed
Sponsors
Pfizer Inc
IQVIA RDSIndia Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults (aged =18 years) with histology-confirmed advanced NSCLC (TNM stage IIIB-IV); 2. Presence of any EGFR-activating mutation (exon 19 deletion or exon 21 L858R substitution) or other uncommon EGFR mutations prior to anti-cancer treatment; 3. Initiating dacomitinib as first-line treatment for advanced NSCLC after confirmation of EGFR-mutation status (ie, no prior treatment with other EGFR TKI or systemic therapy); 4. Received dacomitinib after the following dates (which mark the marketing authorization date in China, or initiation of the compassionate use program in Malaysia and India) • Patients from China: 01 July 2019; • Patients from Malaysia and India: 01 August 2018; 5. Initiated dacomitinib no later than 20 months before end of data collection (to allow minimum of 20 months follow-up from dacomitinib initiation); 6. Had at least one follow-up visit after dacomitinib initiation unless there is a documented death in the patient records before a follow-up visit. For prospective and mixed patients, there should be evidence of a personally signed and dated informed consent document (ICD) indicating that the patient (or a legally acceptable representative, LAR) has been informed of all pertinent aspects of the study.
Exclusion criteria
Exclusion criteria: 1. Enrolled in any interventional clinical study or trial at time of study inclusion (however, patients enrolled in non-interventional, real world study may still be included).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To describe demographics, as well as clinical and disease characteristics of patients on first-line dacomitinib therapy for treatment of EGFR mutation-positive advanced NSCLC. 2. To describe starting dose of dacomitinib as first-line therapy, dose modification (if any), related timing and reason for dose modification, interruption or discontinuation. 3. To describe duration of dacomitinib therapy and time-to-treatment failure (TTF). Timepoint: Time-to-treatment failure (TTF). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To describe real-world PFS of patients. 2. To characterize all adverse events (AEs) for patients treated with dacomitinib. 3. To describe TTF, PFS, overall survival (OS) and AEsTimepoint: Time-to-treatment failure TTF, PFS, overall survival and AEs | — |
Countries
China, India, Malaysia
Contacts
Public ContactJinu Jose
IQVIA RDS (India) Private Limited
Outcome results
None listed