Clinical trial NCT04609319: 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
Official title: ARIA: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-10-30
Enrollment: 307
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tertiary cancer-treating hospitals in China, India and Malaysia are planned as participating sites.

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Body Mass Index (BMI): All Asian Participants
timeFrame: Baseline (date of last non-missing measurement prior to dacomitinib initiation; from data collected for approx. [approximately] 89 months); data was evaluated in this observational study for approx. 35.5 months
measure: Number of Participants Classified According to Smoking Status: All Asian Participants
timeFrame: Baseline (date of last non-missing measurement prior to dacomitinib initiation; from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months
measure: Number of Participants Classified According to Comorbidities: All Asian Participants
timeFrame: Baseline (date of last non-missing measurement prior to dacomitinib initiation; from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months
measure: Number of Participants Classified According to NSCLC Staging: All Asian Participants
timeFrame: Baseline (date of last non-missing measurement prior to dacomitinib initiation; from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months
measure: Number of Participants Classified According to Eastern Cooperative Oncology Group (ECOG) Performance Status: All Asian Participants
timeFrame: Baseline (date of last non-missing measurement prior to dacomitinib initiation; from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months
measure: Number of Participants Classified According to Type of EGFR Mutation: All Asian Participants
timeFrame: Baseline (date of last non-missing measurement prior to dacomitinib initiation; from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months
measure: Number of Participants Classified According to Number of Oral Dose Modifications: All Asian Participants
timeFrame: From start of dacomitinib treatment until discontinuation/end of treatment (from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months
measure: Number of Participants Classified According to Number of Oral Dose Interruptions: All Asian Participants
timeFrame: From start of dacomitinib treatment until discontinuation/end of treatment (from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months
measure: Number of Participants With Any Oral Dose Discontinuation: All Asian Participants
timeFrame: From start of dacomitinib treatment until discontinuation/end of treatment (from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months
measure: Duration of Dacomitinib Therapy: All Asian Participants
timeFrame: First dose of dacomitinib till discontinuation/ end of dacomitinib treatment (from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months
measure: Time To Treatment Failure (TTF): All Asian Participants
timeFrame: From dacomitinib treatment initiation to dacomitinib discontinuation, PD or death due to any cause, whichever came first or censoring date (from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months
Secondary outcomes:
measure: Progression-free Survival (PFS): All Asian Participants
timeFrame: From dacomitinib treatment initiation to PD or death due to any cause, whichever came first or censoring date (from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months
measure: Number of Participants With Adverse Events (AEs): All Asian Participants
timeFrame: From dacomitinib treatment initiation to death or end of study whichever occurred first (from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months
measure: TTF: Chinese Participants With Common EGFR Mutation
timeFrame: From dacomitinib treatment initiation to dacomitinib discontinuation, PD or death due to any cause, whichever came first or censoring date (from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months
measure: PFS: Chinese Participants With Common EGFR Mutation
timeFrame: From dacomitinib treatment initiation to PD or death due to any cause, whichever came first or censoring date (from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months
measure: Number of Participants With AEs: Chinese Participants With Common EGFR Mutation
timeFrame: From dacomitinib treatment initiation to death or end of study whichever occurred first (from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months
measure: Number of Participants Classified According to Starting Dose of Dacomitinib as First-line Therapy: Chinese Participants With Common EGFR Mutation
timeFrame: From start of dacomitinib treatment until discontinuation/end of treatment (from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months
measure: Number of Participants Without Oral Dose Modifications: Chinese Participants With Common EGFR Mutation
timeFrame: From start of dacomitinib treatment until discontinuation/end of treatment (from data collected for approx. 89 months); data was evaluated in this observational study for approx. 35.5 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-Sen University
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Changsha
country: China
facility: Hunan Provincial Tumor Hospital
state: Hunan
city: Changchun
country: China
facility: The First hospital of Jilin University
state: Jilin
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Beijing
country: China
facility: Internal Medicine, Chinese Academy of Medical Sciences Cancer Hospital
city: Shenyang, Liaoning Province
country: China
facility: The First Affiliated Hospital of China Medical University
city: New Delhi
country: India
facility: Rajiv Gandhi Cancer Institute And Research Centre
state: DEL
city: Kolkata, West Bengal
country: India
facility: Tata Memorial Center, Kolkata
city: Kuala Lumpur
country: Malaysia
facility: Pantai Hospital Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Petaling Jaya
country: Malaysia
facility: Beacon Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: