A multi-center chart review with dacomitinib first-line treatment for EGFR mutation-positive advanced non-small cell lung cancer among Asian patients

Not Applicable

• Conditions: Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung

• Registration Number: CTRI/2022/04/042082
• Lead Sponsor: Pfizer Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 19 December 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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).

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br/ ><br>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. <br/ ><br>3. To describe duration of dacomitinib therapy and time-to-treatment failure (TTF). <br/ ><br>Timepoint: Time-to-treatment failure (TTF). <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1. To describe real-world PFS of patients. <br/ ><br>2. To characterize all adverse events (AEs) for patients treated with dacomitinib. <br/ ><br>3. To describe TTF, PFS, overall survival (OS) and AEsTimepoint: Time-to-treatment failure TTF, PFS, overall survival and AEs