Real World Utilization and Outcomes With Dacomitinib First Line Treatment for EGFR Mutation-positive Advanced Non Small Cell Lung Cancer Among Asian Patients - A Multi Center Chart Review

NCT ID: NCT04609319

Last Updated: 2025-05-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

307 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-11

Study Completion Date

2024-05-28

Brief Summary

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This is a longitudinal, consecutive case-series, multi-center study with mixed prospective and retrospective data collection. Data will be collected from eligible adults with EGFR mutation-positive advanced non-small cell lung cancer (NSCLC) treated with dacomitinib as first-line therapy from the date of advanced NSCLC diagnosis to the date of death, lost to follow-up, withdrawal of consent or end of study, whichever occurs first.

Detailed Description

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Conditions

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Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Cohort 1

Dacomitinib

Intervention Type DRUG

This is a non-interventional, real world study of Asian patients being treated with dacomitinib as first-line treatment for EGFR+ NSCLC

Interventions

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Dacomitinib

This is a non-interventional, real world study of Asian patients being treated with dacomitinib as first-line treatment for EGFR+ NSCLC

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult (aged ≥18 years) with histology-confirmed advanced NSCLC (TNM stage IIIB-IV);
* Presence of any EGFR-activating mutation (exon 19 deletion or exon 21 L858R substitution) or other uncommon EGFR mutations prior to anti-cancer treatment;
* Initiating dacomitinib as first-line treatment after confirmation of EGFR-mutation status (ie, no prior treatment with other EGFR TKI or systemic therapy);

Exclusion Criteria

* Enrolled in any interventional clinical study or trial (however, patients enrolled in non-interventional, real world study may still be included).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Site Status

The First Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status

Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status

Hunan Provincial Tumor Hospital

Changsha, Hunan, China

Site Status

The First hospital of Jilin University

Changchun, Jilin, China

Site Status

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Site Status

Internal Medicine, Chinese Academy of Medical Sciences Cancer Hospital

Beijing, , China

Site Status

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning Province, , China

Site Status

Rajiv Gandhi Cancer Institute And Research Centre

New Delhi, DEL, India

Site Status

Tata Memorial Center, Kolkata

Kolkata, West Bengal, , India

Site Status

Pantai Hospital Kuala Lumpur

Kuala Lumpur, , Malaysia

Site Status

University Malaya Medical Centre

Kuala Lumpur, , Malaysia

Site Status

Beacon Hospital

Petaling Jaya, , Malaysia

Site Status

Countries

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China India Malaysia

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=A7471067

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Other Identifiers

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A7471067

Identifier Type: -

Identifier Source: org_study_id

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