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

Completed Results posted Last updated 31 May 2025

What this trial tests

trial testing Dacomitinib in Lung Cancer in 307 participants. Completed in 28 May 2024.

Timeline

11 June 2021

Primary endpoint
28 May 2024

28 May 2024

Quick facts

Lead sponsor	Pfizer
Status	Completed
Study type	OBSERVATIONAL
Enrollment	307
Start date	11 June 2021
Primary completion	28 May 2024
Estimated completion	28 May 2024
Sites	14 locations across China, Malaysia, India

Drugs / interventions tested

• Dacomitinib (Dacomitinib) — full drug profile →

Conditions studied

• Lung Cancer — all drugs for Lung Cancer →

Sponsor

Pfizer — full company profile →

Who can join

18 and older, any sex, with Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Body Mass Index (BMI): All Asian Participants Primary · 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.

Group	Value	95% CI
Dacomitinib 30 mg	22.6	± 3.57
Dacomitinib 45 mg	23.1	± 3.44
Dacomitinib Other Dose	26.4

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

Group	Value	95% CI
Dacomitinib 30 mg	2
Dacomitinib 45 mg	11
Dacomitinib Other Dose	0
Dacomitinib 30 mg	24
Dacomitinib 45 mg	41
Dacomitinib Other Dose	1
Dacomitinib 30 mg	93
Dacomitinib 45 mg	71
Dacomitinib Other Dose	1
Dacomitinib 30 mg	40
Dacomitinib 45 mg	15
Dacomitinib Other Dose	0

Number of Participants Classified According to Comorbidities: All Asian Participants Primary · 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.

Group	Value	95% CI
Dacomitinib 30 mg	44
Dacomitinib 45 mg	22
Dacomitinib Other Dose	1
Dacomitinib 30 mg	97
Dacomitinib 45 mg	109
Dacomitinib Other Dose	1
Dacomitinib 30 mg	18
Dacomitinib 45 mg	7
Dacomitinib Other Dose	0

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

Group	Value	95% CI
Dacomitinib 30 mg	6
Dacomitinib 45 mg	8
Dacomitinib Other Dose	2
Dacomitinib 30 mg	0
Dacomitinib 45 mg	4
Dacomitinib Other Dose	0
Dacomitinib 30 mg	56
Dacomitinib 45 mg	46
Dacomitinib Other Dose	0
Dacomitinib 30 mg	97
Dacomitinib 45 mg	80
Dacomitinib Other Dose	0

Number of Participants Classified According to Eastern Cooperative Oncology Group (ECOG) Performance Status: All Asian Participants Primary · 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

Group	Value	95% CI
Dacomitinib 30 mg	20
Dacomitinib 45 mg	11
Dacomitinib Other Dose	0
Dacomitinib 30 mg	59
Dacomitinib 45 mg	80
Dacomitinib Other Dose	0
Dacomitinib 30 mg	0
Dacomitinib 45 mg	5
Dacomitinib Other Dose	1
Dacomitinib 30 mg	2
Dacomitinib 45 mg	1
Dacomitinib Other Dose	0

Number of Participants Classified According to Type of EGFR Mutation: All Asian Participants Primary · 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.

EGFR exon 19 deletion

Group	Value	95% CI
Dacomitinib 30 mg	54
Dacomitinib 45 mg	36
Dacomitinib Other Dose	1

EGFR exon 21 L858R substitution

Group	Value	95% CI
Dacomitinib 30 mg	102
Dacomitinib 45 mg	89
Dacomitinib Other Dose	1

EGFR T790M mutation

Group	Value	95% CI
Dacomitinib 30 mg	0
Dacomitinib 45 mg	2
Dacomitinib Other Dose	0

Other

Group	Value	95% CI
Dacomitinib 30 mg	22
Dacomitinib 45 mg	37
Dacomitinib Other Dose	0

Number of Participants Classified According to Number of Oral Dose Modifications: All Asian Participants Primary · 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.

Group	Value	95% CI
Dacomitinib 30 mg	128
Dacomitinib 45 mg	67
Dacomitinib Other Dose	1
Dacomitinib 30 mg	16
Dacomitinib 45 mg	41
Dacomitinib Other Dose	0
Dacomitinib 30 mg	11
Dacomitinib 45 mg	29
Dacomitinib Other Dose	0
Dacomitinib 30 mg	4
Dacomitinib 45 mg	1
Dacomitinib Other Dose	1

Number of Participants Classified According to Number of Oral Dose Interruptions: All Asian Participants Primary · 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.

Group	Value	95% CI
Dacomitinib 30 mg	142
Dacomitinib 45 mg	115
Dacomitinib Other Dose	1
Dacomitinib 30 mg	10
Dacomitinib 45 mg	20
Dacomitinib Other Dose	0
Dacomitinib 30 mg	4
Dacomitinib 45 mg	2
Dacomitinib Other Dose	1
Dacomitinib 30 mg	3
Dacomitinib 45 mg	1
Dacomitinib Other Dose	0

Number of Participants With Any Oral Dose Discontinuation: All Asian Participants Primary · 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.

Group	Value	95% CI
Dacomitinib 30 mg	116
Dacomitinib 45 mg	105
Dacomitinib Other Dose	2

Duration of Dacomitinib Therapy: All Asian Participants Primary · 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.

Group	Value	95% CI
Dacomitinib 30 mg	17.4	1.1 – 68.1
Dacomitinib 45 mg	16.6	0.7 – 48.9
Dacomitinib Other Dose	14.9	8.9 – 20.8

Time To Treatment Failure (TTF): All Asian Participants Primary · 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 c

Group	Value	95% CI
Dacomitinib 30 mg	15.8	13.40 – 19.88
Dacomitinib 45 mg	17.7	14.39 – 21.16
Dacomitinib Other Dose	14.5	8.34 – NA

Progression-free Survival (PFS): All Asian Participants Secondary · 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

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.

Group	Value	95% CI
Dacomitinib 30 mg	18.3	15.47 – 26.51
Dacomitinib 45 mg	21.0	17.38 – 24.15
Dacomitinib Other Dose	14.5	8.34 – NA

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Wu L, Li J, Xu CR, Biswas B, et al · · 2026 · cited 1× · PMID 41365111 · DOI 10.1016/j.lungcan.2025.108856