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

An observational study of Lung Cancer, run by Pfizer at 14 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Cancer
What is being tested?: Dacomitinib
How many people: 307 participants
Where: 14 sitesin 3 countries
Study dates: 11 Jun 2021to 28 May 2024
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Tertiary cancer-treating hospitals in China, India and Malaysia are planned as participating sites.

Who may be able to join

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);

Who cannot join

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

Trial locations and contacts

14 sites in 3 countries.

Country

City, postcode or hospital

14 sites in 3 countries

China9 sites

Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Internal Medicine, Chinese Academy of Medical Sciences Cancer Hospital
Beijing, 100021
The First hospital of Jilin University
Changchun, Jilin, 130021
Hunan Provincial Tumor Hospital
Changsha, Hunan, 410013
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
The First Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510080
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning Province
Henan Cancer Hospital
Zhengzhou, Henan, 450008

Other trials in China

Malaysia3 sites

Pantai Hospital Kuala Lumpur
Kuala Lumpur, 59100
University Malaya Medical Centre
Kuala Lumpur, 59100
Beacon Hospital
Petaling Jaya, 46050

Other trials in Malaysia

India2 sites

Tata Memorial Center, Kolkata
Kolkata, West Bengal, 700156
Rajiv Gandhi Cancer Institute And Research Centre
New Delhi, DEL, 110085

Other trials in India

About this study

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

Conditions: Lung Cancer
Being tested: Dacomitinib
Medical subject headings: Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04609319
Study group	Role	What they receive
Cohort 1		Not described Receives: Drug: Dacomitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

Body Mass Index (BMI): All Asian Participants
BMI was derived from body weight and height, and it was calculated as weight divided by height^2.
Measured: 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
Number of Participants Classified According to Smoking Status: All Asian Participants
Number of participants classified according to smoking status are presented in this outcome measure. Participants were classified into the following categories: current smoker, former smoker, never smoker and unknown.
Measured: 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
Number of Participants Classified According to Comorbidities: All Asian Participants
Number of participants classified According to comorbidities are presented in this outcome measure. Participants were classified into the following categories: any comorbidities, none and unknown.
Measured: 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
Number of Participants Classified According to NSCLC Staging: All Asian Participants
The number of participants classified according to the disease stages as 3B, 3C, 4A and 4B were reported in this outcome measure. Cancer stages were classified based on tumor size (T), metastasis to regional lymph nodes (LN) [N] and distant metastasis (M). Stages were 3B, 3C, 4A and 4B. Stage 3B (T1N3M0, T2N3M0, T3N2M0, T4N2M0). Stage 3C (T3N3M0 and T4N3M0), Stage 4A (anyT, anyN and M1a/M1b), Stage 4B (anyT, anyN and M1c). where T1: <=3 cm; T2: >3 to <=5 cm; T3: >5 to <=7 cm; T4: >7cm. N0: not spread to regional LN; N1: spread to ipsilateral pulmonary or hilar nodes; N2: spread to ipsilateral mediastinal or subcarinal nodes; N3: spread to contralateral mediastinal, hilar, or supraclavicular nodes. M0: no distant metastasis; M1a: malignant pleural or pericardial effusion or pleural or pericardial nodules or separate tumor nodule(s) in a contralateral lobe; M1b: single extrathoracic metastasis; M1c= multiple extrathoracic metastases (1 or >1 organ).
Measured: 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
Number of Participants Classified According to Eastern Cooperative Oncology Group (ECOG) Performance Status: All Asian Participants
ECOG performance classified as: Grade 0: fully active, able to carry on all pre-disease performance without restriction; Grade 1: restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature; Grade 2: ambulatory and capable of all selfcare but unable to carry out any work activities, up and about more than 50% of waking hours; Grade 3: capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; Grade 4: completely disabled, cannot carry on selfcare and totally confined to bed or chair and Grade 5: dead. Higher score indicated worse health status.
Measured: 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
Number of Participants Classified According to Type of EGFR Mutation: All Asian Participants
Number of participants classified according to type of EGFR mutation were reported in this outcome measure. One participant may have more than one mutation. Participants were classified into the following rows: EGFR exon 19 deletion, EGFR exon 21 L858R substitution, EGFR T790M mutation and other.
Measured: 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
Number of Participants Classified According to Number of Oral Dose Modifications: All Asian Participants
Number of participants with dacomitinib oral dose modification (any dose change) from initial dacomitinib therapy are presented in this outcome measure. Participants were classified into the following categories: no dose modification, one dose modification, two dose modifications and more than two dose modifications.
Measured: 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
Number of Participants Classified According to Number of Oral Dose Interruptions: All Asian Participants
Number of participants with dacomitinib dose interruption (dacomitinib treatment being temporarily stopped) were reported in this outcome measure. Participants were classified into the following categories: no dose interruption, one dose interruption, two dose interruptions and more than two dose interruptions.
Measured: 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
Number of Participants With Any Oral Dose Discontinuation: All Asian Participants
Number of participants with dacomitinib dose discontinuation (dacomitinib treatment permanently stopped) were reported in this outcome measure.
Measured: 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
Duration of Dacomitinib Therapy: All Asian Participants
Duration of dacomitinib therapy (dacomitinib last dose date - dacomitinib initiation date + 1 day) was reported in this outcome measure.
Measured: 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
Time To Treatment Failure (TTF): All Asian Participants
TTF was defined as the time from date of dacomitinib initiation to date of dacomitinib permanent discontinuation (for any reason), first disease progression (PD), or death (from any cause), whichever came first. PD was defined as cancer worsening based on radiologist's interpretation of the imaging and/or clinician's assessment, and after initiation of first-line dacomitinib treatment. Participants who remained on dacomitinib without an event until end of follow-up were censored at the date of last known contact/visit date. Participants lost to follow-up were censored based on the last known contact/visit date. Kaplan-Meier method was used for analysis.
Measured: 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 (7)

Progression-free Survival (PFS): All Asian Participants
PFS was defined as date of dacomitinib initiation to date of first PD or death from any cause, whichever came first. PD was defined as cancer worsening based on radiologist's interpretation of the imaging and/or clinician's assessment, and after initiation of first-line dacomitinib treatment. Participants without PD and remained alive (i.e. no date of death) until end of follow-up were censored at the date of last known contact/visit date. Participants lost to follow-up were censored based on the last known contact/visit date. Kaplan-Meier method was used for analysis.
Measured: 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
Number of Participants With Adverse Events (AEs): All Asian Participants
AE was any untoward medical occurrence in a participant or clinical investigation participant administered sponsor's product and which did not necessarily have a causal relationship with the product.
Measured: 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
TTF: Chinese Participants With Common EGFR Mutation
TTF was defined as the time from date of dacomitinib initiation to date of dacomitinib permanent discontinuation (for any reason), first PD, or death (from any cause), whichever came first. PD was defined as cancer worsening based on radiologist's interpretation of the imaging and/or clinician's assessment, and after initiation of first-line dacomitinib treatment. Participants who remained on dacomitinib without an event until end of follow-up were censored at the date of last known contact/visit date. Participants lost to follow-up were censored based on the last known contact/visit date. Kaplan-Meier method was used for analysis.
Measured: 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
PFS: Chinese Participants With Common EGFR Mutation
PFS was defined as date of dacomitinib initiation to date of first PD or death from any cause, whichever came first. PD was defined as cancer worsening based on radiologist's interpretation of the imaging and/or clinician's assessment, and after initiation of first-line dacomitinib treatment. Participants without PD and remained alive (i.e. no date of death) until end of follow-up were censored at the date of last known contact/visit date. Participants lost to follow-up were censored based on the last known contact/visit date. Kaplan-Meier method was used for analysis.
Measured: 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
Number of Participants With AEs: Chinese Participants With Common EGFR Mutation
AE was any untoward medical occurrence in a participant or clinical investigation participant administered sponsor's product and which did not necessarily have a causal relationship with the product.
Measured: 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
Number of Participants Classified According to Starting Dose of Dacomitinib as First-line Therapy: Chinese Participants With Common EGFR Mutation
Number of participants classified according to starting dose of dacomitinib (30 mg, 45 mg or other dose) as first-line in Chinese participants with common EGFR mutations are presented in this outcome measure.
Measured: 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
Number of Participants Without Oral Dose Modifications: Chinese Participants With Common EGFR Mutation
Number of participants without any dacomitinib dose modification (any dose change) from initial dacomitinib therapy in Chinese participants with common EGFR mutations are presented in this outcome measure.
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jun 202128 May 2024

First posted30 Oct 2020
Study start11 Jun 2021
Primary completion28 May 2024
Study completion28 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Lung CancerStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Other
Enrolment: 307 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04609319
Sponsor's protocol ID: A7471067
Status last verified: May 2025
First submitted: 23 Oct 2020
Last updated: 31 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

Wu L, Li J, Xu CR, Biswas B, Roy S, Tang KJ, Wang H, Liu Z, Batra U, Ho GF, Seng Hooi JL, Lu Y, Zhao M, Tho LM, Zhao J, He S, Huang J, Zhang H, Wong CH, Wu YL. Real-world use of and clinical outcomes with dacomitinib as first-line therapy in Asian patients with EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer: Final analysis of the ARIA study. Lung Cancer. 2026 Jan;211:108856. doi: 10.1016/j.lungcan.2025.108856. Epub 2025 Nov 25.
PubMed 41365111

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04609319
Acronym / sponsor ID: A7471067
Conditions: Lung Cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 307 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 11 Jun 2021 (actual)
Primary completion: 28 May 2024 (actual)
Study completion: 28 May 2024 (actual)
First posted: 30 Oct 2020 (actual)
Results: Posted 31 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Other
Number of arms: 1

Arm	Type	Receives
Cohort 1	–	Drug: Dacomitinib

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Tertiary cancer-treating hospitals in China, India and Malaysia are planned as participating sites.

Key inclusion criteria (3 listed)

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);

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DacomitinibThis is a non-interventional, real world study of Asian patients being treated with dacomitinib as first-line treatment for EGFR+ NSCLC	Drug	Cohort 1

Primary outcome

Body Mass Index (BMI): All Asian Participants
Time frame: 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
BMI was derived from body weight and height, and it was calculated as weight divided by height^2.
Number of Participants Classified According to Smoking Status: All Asian Participants
Time frame: 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
Number of participants classified according to smoking status are presented in this outcome measure. Participants were classified into the following categories: current smoker, former smoker, never smoker and unknown.
Number of Participants Classified According to Comorbidities: All Asian Participants
Time frame: 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
Number of participants classified According to comorbidities are presented in this outcome measure. Participants were classified into the following categories: any comorbidities, none and unknown.
Number of Participants Classified According to NSCLC Staging: All Asian Participants
Time frame: 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
The number of participants classified according to the disease stages as 3B, 3C, 4A and 4B were reported in this outcome measure. Cancer stages were classified based on tumor size (T), metastasis to regional lymph nodes (LN) [N] and distant metastasis (M). Stages were 3B, 3C, 4A and 4B. Stage 3B (T1N3M0, T2N3M0, T3N2M0, T4N2M0). Stage 3C (T3N3M0 and T4N3M0), Stage 4A (anyT, anyN and M1a/M1b), Stage 4B (anyT, anyN and M1c). where T1: <=3 cm; T2: >3 to <=5 cm; T3: >5 to <=7 cm; T4: >7cm. N0: not spread to regional LN; N1: spread to ipsilateral pulmonary or hilar nodes; N2: spread to ipsilateral mediastinal or subcarinal nodes; N3: spread to contralateral mediastinal, hilar, or supraclavicular nodes. M0: no distant metastasis; M1a: malignant pleural or pericardial effusion or pleural or pericardial nodules or separate tumor nodule(s) in a contralateral lobe; M1b: single extrathoracic metastasis; M1c= multiple extrathoracic metastases (1 or >1 organ).
Number of Participants Classified According to Eastern Cooperative Oncology Group (ECOG) Performance Status: All Asian Participants
Time frame: 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
ECOG performance classified as: Grade 0: fully active, able to carry on all pre-disease performance without restriction; Grade 1: restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature; Grade 2: ambulatory and capable of all selfcare but unable to carry out any work activities, up and about more than 50% of waking hours; Grade 3: capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; Grade 4: completely disabled, cannot carry on selfcare and totally confined to bed or chair and Grade 5: dead. Higher score indicated worse health status.
Number of Participants Classified According to Type of EGFR Mutation: All Asian Participants
Time frame: 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
Number of participants classified according to type of EGFR mutation were reported in this outcome measure. One participant may have more than one mutation. Participants were classified into the following rows: EGFR exon 19 deletion, EGFR exon 21 L858R substitution, EGFR T790M mutation and other.
Number of Participants Classified According to Number of Oral Dose Modifications: All Asian Participants
Time frame: 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
Number of participants with dacomitinib oral dose modification (any dose change) from initial dacomitinib therapy are presented in this outcome measure. Participants were classified into the following categories: no dose modification, one dose modification, two dose modifications and more than two dose modifications.
Number of Participants Classified According to Number of Oral Dose Interruptions: All Asian Participants
Time frame: 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
Number of participants with dacomitinib dose interruption (dacomitinib treatment being temporarily stopped) were reported in this outcome measure. Participants were classified into the following categories: no dose interruption, one dose interruption, two dose interruptions and more than two dose interruptions.
Number of Participants With Any Oral Dose Discontinuation: All Asian Participants
Time frame: 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
Number of participants with dacomitinib dose discontinuation (dacomitinib treatment permanently stopped) were reported in this outcome measure.
Duration of Dacomitinib Therapy: All Asian Participants
Time frame: 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
Duration of dacomitinib therapy (dacomitinib last dose date - dacomitinib initiation date + 1 day) was reported in this outcome measure.
Time To Treatment Failure (TTF): All Asian Participants
Time frame: 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
TTF was defined as the time from date of dacomitinib initiation to date of dacomitinib permanent discontinuation (for any reason), first disease progression (PD), or death (from any cause), whichever came first. PD was defined as cancer worsening based on radiologist's interpretation of the imaging and/or clinician's assessment, and after initiation of first-line dacomitinib treatment. Participants who remained on dacomitinib without an event until end of follow-up were censored at the date of last known contact/visit date. Participants lost to follow-up were censored based on the last known contact/visit date. Kaplan-Meier method was used for analysis.

7 secondary outcomes

Progression-free Survival (PFS): All Asian Participants
Time frame: 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
Number of Participants With Adverse Events (AEs): All Asian Participants
Time frame: 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
TTF: Chinese Participants With Common EGFR Mutation
Time frame: 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
PFS: Chinese Participants With Common EGFR Mutation
Time frame: 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
Number of Participants With AEs: Chinese Participants With Common EGFR Mutation
Time frame: 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
Number of Participants Classified According to Starting Dose of Dacomitinib as First-line Therapy: Chinese Participants With Common EGFR Mutation
Time frame: 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
Number of Participants Without Oral Dose Modifications: Chinese Participants With Common EGFR Mutation
Time frame: 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

Results and safety

Results posted to the registry on 31 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dacomitinib 30 mg	159	0
Dacomitinib 45 mg	138	0
Dacomitinib Other Dose	2	0

Primary outcome: Body Mass Index (BMI): All Asian Participants

Time frame: 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. Mean (Standard Deviation). Unit: Kilogram per square meter

Measure	Dacomitinib 30 mg n = 96	Dacomitinib 45 mg n = 114	Dacomitinib Other Dose n = 1
Value	22.6 (3.57)	23.1 (3.44)	26.4

Population analysed: FAS included all eligible participants who fulfilled all inclusion and exclusion criteria and provided informed consent (or with IRB/ IEC waiver of informed consent). Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Primary outcome: Number of Participants Classified According to Smoking Status: All Asian Participants

Time frame: 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. Count of participants. Unit: Participants

Measure	Dacomitinib 30 mg n = 159	Dacomitinib 45 mg n = 138	Dacomitinib Other Dose n = 2
Current smoker	2	11	0
Former smoker	24	41	1
Never smoker	93	71	1
Unknown	40	15	0

Population analysed: FAS included all eligible participants who fulfilled all inclusion and exclusion criteria and provided informed consent (or with IRB/ IEC waiver of informed consent).

Primary outcome: Number of Participants Classified According to Comorbidities: All Asian Participants

Measure	Dacomitinib 30 mg n = 159	Dacomitinib 45 mg n = 138	Dacomitinib Other Dose n = 2
Any comorbidities	44	22	1
None	97	109	1
Unknown	18	7	0

Population analysed: FAS included all eligible participants who fulfilled all inclusion and exclusion criteria and provided informed consent (or with IRB/ IEC waiver of informed consent).

Primary outcome: Number of Participants Classified According to NSCLC Staging: All Asian Participants

Measure	Dacomitinib 30 mg n = 159	Dacomitinib 45 mg n = 138	Dacomitinib Other Dose n = 2
3B	6	8	2
3C	0	4	0
4A	56	46	0
4B	97	80	0

Population analysed: FAS included all eligible participants who fulfilled all inclusion and exclusion criteria and provided informed consent (or with IRB/ IEC waiver of informed consent).

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-cause mortality: 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; for adverse events it was not applicable due to non-interventional nature of the study adverse events were not planned to be assessed/monitored. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dacomitinib 30 mg	0 of 0	0 of 0	64 of 159
Dacomitinib 45 mg	0 of 0	0 of 0	49 of 138
Dacomitinib Other Dose	0 of 0	0 of 0	1 of 2

Limitations and caveats (from the sponsor): Due to non-interventional nature of the study, adverse events and their seriousness were not monitored/assessed; only summarized data is reported per objectives of the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41365111Wu L, Li J, Xu CR, Biswas B, Roy S, Tang KJ, Wang H, Liu Z, Batra U, Ho GF, Seng Hooi JL, Lu Y, Zhao M, Tho LM, Zhao J, He S, Huang J, Zhang H, Wong CH, Wu YL. Real-world use of and clinical outcomes with dacomitinib as first-line therapy in Asian patients with EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer: Final analysis of the ARIA study. Lung Cancer. 2026 Jan;211:108856. doi: 10.1016/j.lungcan.2025.108856. Epub 2025 Nov 25.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

14 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Cancer, run by Pfizer at 14 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in China, Malaysia, India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body Mass Index (BMI): All Asian Participants (time frame: 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). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04609319, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.