Trial Outcomes & Findings for 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 NCT04609319)

NCT ID: NCT04609319

Last Updated: 2025-05-31

Results Overview

BMI was derived from body weight and height, and it was calculated as weight divided by height\^2.

• Recruitment status: COMPLETED
• Target enrollment: 307 participants
• Primary outcome 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
• Results posted on: 2025-05-31

Participant Flow

Data of eligible participants who were diagnosed with epidermal growth factor receptor (EGFR) mutation-positive advanced NSCLC and received first-line treatment with dacomitinib under routine clinical practice was included. Participants did not receive intervention as a part of this study. A total of 307 participants were enrolled. Of these, 8 participants were excluded from any analysis (7 participants failed to meet the eligibility criteria and 1 participant was a duplicate).

Data was collected retrospectively from medical records (1-Jan-2017 to 23-Nov-2021) or prospectively from prospective data collection (23-Nov-2021 to 28-May-2024) or mixed (retrospective and prospective, 1-Jan-2017 to 28-May-2024 [89 months]). Available data from eligible participants was evaluated in approximately 35.5 months (study start date: 11-June-2021 to study completion date: 28-May-2024) of this observational study as per its objectives.

Participant milestones

Measure	Dacomitinib 30 mg Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 milligrams (mg), once daily in a real world setting under routine clinical practice outside of clinical trials were included.	Dacomitinib 45 mg Participants who initiated treatment with dacomitinib as first line therapy at a dose of 45 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.	Dacomitinib Other Dose Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, twice daily or 15 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.
Overall Study STARTED	159	138	2
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	159	138	2

Reasons for withdrawal

Measure	Dacomitinib 30 mg Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 milligrams (mg), once daily in a real world setting under routine clinical practice outside of clinical trials were included.	Dacomitinib 45 mg Participants who initiated treatment with dacomitinib as first line therapy at a dose of 45 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.	Dacomitinib Other Dose Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, twice daily or 15 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.
Overall Study Death	64	49	1
Overall Study Withdrawal of consent	15	3	0
Overall Study Lost to Follow-up	20	33	0
Overall Study Alive until end of follow-up	60	53	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Dacomitinib 30 mg n=159 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.	Dacomitinib 45 mg n=138 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 45 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.	Dacomitinib Other Dose n=2 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, twice daily or 15 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.	Total n=299 Participants Total of all reporting groups
Age, Continuous	61.5 Years STANDARD_DEVIATION 9.77 • n=5 Participants	57.6 Years STANDARD_DEVIATION 9.29 • n=7 Participants	70.5 Years STANDARD_DEVIATION 12.02 • n=5 Participants	59.8 Years STANDARD_DEVIATION 9.76 • n=4 Participants
Sex: Female, Male Female	101 Participants n=5 Participants	59 Participants n=7 Participants	1 Participants n=5 Participants	161 Participants n=4 Participants
Sex: Female, Male Male	58 Participants n=5 Participants	79 Participants n=7 Participants	1 Participants n=5 Participants	138 Participants n=4 Participants
Race/Ethnicity, Customized Chinese	145 Participants n=5 Participants	125 Participants n=7 Participants	2 Participants n=5 Participants	272 Participants n=4 Participants
Race/Ethnicity, Customized Malay	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Indian	12 Participants n=5 Participants	13 Participants n=7 Participants	0 Participants n=5 Participants	25 Participants n=4 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

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

Population: 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.

BMI was derived from body weight and height, and it was calculated as weight divided by height^2.

Outcome measures

Measure	Dacomitinib 30 mg n=96 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.	Dacomitinib 45 mg n=114 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 45 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.	Dacomitinib Other Dose n=1 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, twice daily or 15 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.
Body Mass Index (BMI): All Asian Participants	22.6 Kilogram per square meter Standard Deviation 3.57	23.1 Kilogram per square meter Standard Deviation 3.44	26.4 Kilogram per square meter

PRIMARY outcome

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

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

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.

Outcome measures

Measure	Dacomitinib 30 mg n=159 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.	Dacomitinib 45 mg n=138 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 45 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.	Dacomitinib Other Dose n=2 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, twice daily or 15 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.
Number of Participants Classified According to Smoking Status: All Asian Participants Current smoker	2 Participants	11 Participants	0 Participants
Number of Participants Classified According to Smoking Status: All Asian Participants Former smoker	24 Participants	41 Participants	1 Participants
Number of Participants Classified According to Smoking Status: All Asian Participants Never smoker	93 Participants	71 Participants	1 Participants
Number of Participants Classified According to Smoking Status: All Asian Participants Unknown	40 Participants	15 Participants	0 Participants

PRIMARY outcome

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

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

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.

Outcome measures

Measure	Dacomitinib 30 mg n=159 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.	Dacomitinib 45 mg n=138 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 45 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.	Dacomitinib Other Dose n=2 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, twice daily or 15 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.
Number of Participants Classified According to Comorbidities: All Asian Participants Any comorbidities	44 Participants	22 Participants	1 Participants
Number of Participants Classified According to Comorbidities: All Asian Participants None	97 Participants	109 Participants	1 Participants
Number of Participants Classified According to Comorbidities: All Asian Participants Unknown	18 Participants	7 Participants	0 Participants

PRIMARY outcome

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

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

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).

Outcome measures

Measure	Dacomitinib 30 mg n=159 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.	Dacomitinib 45 mg n=138 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 45 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.	Dacomitinib Other Dose n=2 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, twice daily or 15 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.
Number of Participants Classified According to NSCLC Staging: All Asian Participants 3B	6 Participants	8 Participants	2 Participants
Number of Participants Classified According to NSCLC Staging: All Asian Participants 3C	0 Participants	4 Participants	0 Participants
Number of Participants Classified According to NSCLC Staging: All Asian Participants 4A	56 Participants	46 Participants	0 Participants
Number of Participants Classified According to NSCLC Staging: All Asian Participants 4B	97 Participants	80 Participants	0 Participants

PRIMARY outcome

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

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

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.

Outcome measures

Measure	Dacomitinib 30 mg n=159 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.	Dacomitinib 45 mg n=138 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 45 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.	Dacomitinib Other Dose n=2 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, twice daily or 15 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.
Number of Participants Classified According to Eastern Cooperative Oncology Group (ECOG) Performance Status: All Asian Participants Grade 0	20 Participants	11 Participants	0 Participants
Number of Participants Classified According to Eastern Cooperative Oncology Group (ECOG) Performance Status: All Asian Participants Grade 1	59 Participants	80 Participants	0 Participants
Number of Participants Classified According to Eastern Cooperative Oncology Group (ECOG) Performance Status: All Asian Participants Grade 2	0 Participants	5 Participants	1 Participants
Number of Participants Classified According to Eastern Cooperative Oncology Group (ECOG) Performance Status: All Asian Participants Grade 3	2 Participants	1 Participants	0 Participants
Number of Participants Classified According to Eastern Cooperative Oncology Group (ECOG) Performance Status: All Asian Participants Grade 4	0 Participants	0 Participants	0 Participants
Number of Participants Classified According to Eastern Cooperative Oncology Group (ECOG) Performance Status: All Asian Participants Grade 5	0 Participants	0 Participants	0 Participants
Number of Participants Classified According to Eastern Cooperative Oncology Group (ECOG) Performance Status: All Asian Participants Unknown	73 Participants	40 Participants	1 Participants
Number of Participants Classified According to Eastern Cooperative Oncology Group (ECOG) Performance Status: All Asian Participants Missing	5 Participants	1 Participants	0 Participants

PRIMARY outcome

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

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

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.

Outcome measures

Measure	Dacomitinib 30 mg n=159 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.	Dacomitinib 45 mg n=138 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 45 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.	Dacomitinib Other Dose n=2 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, twice daily or 15 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.
Number of Participants Classified According to Type of EGFR Mutation: All Asian Participants EGFR exon 19 deletion	54 Participants	36 Participants	1 Participants
Number of Participants Classified According to Type of EGFR Mutation: All Asian Participants EGFR exon 21 L858R substitution	102 Participants	89 Participants	1 Participants
Number of Participants Classified According to Type of EGFR Mutation: All Asian Participants EGFR T790M mutation	0 Participants	2 Participants	0 Participants
Number of Participants Classified According to Type of EGFR Mutation: All Asian Participants Other	22 Participants	37 Participants	0 Participants

PRIMARY outcome

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

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

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.

Outcome measures

Measure	Dacomitinib 30 mg n=159 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.	Dacomitinib 45 mg n=138 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 45 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.	Dacomitinib Other Dose n=2 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, twice daily or 15 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.
Number of Participants Classified According to Number of Oral Dose Modifications: All Asian Participants No dose modification	128 Participants	67 Participants	1 Participants
Number of Participants Classified According to Number of Oral Dose Modifications: All Asian Participants One dose modification	16 Participants	41 Participants	0 Participants
Number of Participants Classified According to Number of Oral Dose Modifications: All Asian Participants Two dose modifications	11 Participants	29 Participants	0 Participants
Number of Participants Classified According to Number of Oral Dose Modifications: All Asian Participants More than two dose modifications	4 Participants	1 Participants	1 Participants

PRIMARY outcome

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

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

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.

Outcome measures

Measure	Dacomitinib 30 mg n=159 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.	Dacomitinib 45 mg n=138 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 45 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.	Dacomitinib Other Dose n=2 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, twice daily or 15 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.
Number of Participants Classified According to Number of Oral Dose Interruptions: All Asian Participants More than two dose interruptions	3 Participants	1 Participants	0 Participants
Number of Participants Classified According to Number of Oral Dose Interruptions: All Asian Participants No dose interruptions	142 Participants	115 Participants	1 Participants
Number of Participants Classified According to Number of Oral Dose Interruptions: All Asian Participants One dose interruption	10 Participants	20 Participants	0 Participants
Number of Participants Classified According to Number of Oral Dose Interruptions: All Asian Participants Two dose interruptions	4 Participants	2 Participants	1 Participants

PRIMARY outcome

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

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

Number of participants with dacomitinib dose discontinuation (dacomitinib treatment permanently stopped) were reported in this outcome measure.

Outcome measures

Measure	Dacomitinib 30 mg n=159 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.	Dacomitinib 45 mg n=138 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 45 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.	Dacomitinib Other Dose n=2 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, twice daily or 15 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.
Number of Participants With Any Oral Dose Discontinuation: All Asian Participants	116 Participants	105 Participants	2 Participants

PRIMARY outcome

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

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

Duration of dacomitinib therapy (dacomitinib last dose date - dacomitinib initiation date + 1 day) was reported in this outcome measure.

Outcome measures

Measure	Dacomitinib 30 mg n=159 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.	Dacomitinib 45 mg n=138 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 45 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.	Dacomitinib Other Dose n=2 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, twice daily or 15 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.
Duration of Dacomitinib Therapy: All Asian Participants	17.4 Months Interval 1.1 to 68.1	16.6 Months Interval 0.7 to 48.9	14.9 Months Interval 8.9 to 20.8

PRIMARY outcome

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

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

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.

Outcome measures

Measure	Dacomitinib 30 mg n=159 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.	Dacomitinib 45 mg n=138 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 45 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.	Dacomitinib Other Dose n=2 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, twice daily or 15 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.
Time To Treatment Failure (TTF): All Asian Participants	15.8 Months Interval 13.4 to 19.88	17.7 Months Interval 14.39 to 21.16	14.5 Months Interval 8.34 to Upper limit of 95% confidence interval (CI) could not be estimated due to insufficient number of participants with events.

SECONDARY outcome

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

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

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.

Outcome measures

Measure	Dacomitinib 30 mg n=159 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.	Dacomitinib 45 mg n=138 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 45 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.	Dacomitinib Other Dose n=2 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, twice daily or 15 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.
Progression-free Survival (PFS): All Asian Participants	18.3 Months Interval 15.47 to 26.51	21.0 Months Interval 17.38 to 24.15	14.5 Months Interval 8.34 to Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.

SECONDARY outcome

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

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

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.

Outcome measures

Measure	Dacomitinib 30 mg n=159 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.	Dacomitinib 45 mg n=138 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 45 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.	Dacomitinib Other Dose n=2 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, twice daily or 15 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.
Number of Participants With Adverse Events (AEs): All Asian Participants	79 Participants	82 Participants	1 Participants

SECONDARY outcome

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

Population: 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 Chinese participants with common EGFR mutation evaluable for this outcome measure.

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.

Outcome measures

Measure	Dacomitinib 30 mg n=133 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.	Dacomitinib 45 mg n=113 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 45 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.	Dacomitinib Other Dose n=1 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, twice daily or 15 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.
TTF: Chinese Participants With Common EGFR Mutation	17.3 Months Interval 14.46 to 20.6	18.9 Months Interval 14.52 to 22.51	NA Months There was only 1 participant evaluable with TTF of 8.3 months.

SECONDARY outcome

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

Population: 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 Chinese participants with common EGFR mutation evaluable for this outcome measure.

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.

Outcome measures

Measure	Dacomitinib 30 mg n=133 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.	Dacomitinib 45 mg n=113 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 45 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.	Dacomitinib Other Dose n=1 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, twice daily or 15 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.
PFS: Chinese Participants With Common EGFR Mutation	20.3 Months Interval 16.99 to 30.29	21.2 Months Interval 18.4 to 25.33	NA Months There was only 1 participant evaluable with PFS of 8.3 months.

SECONDARY outcome

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

Population: 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 Chinese participants with common EGFR mutation evaluable for this outcome measure.

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.

Outcome measures

Measure	Dacomitinib 30 mg n=133 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.	Dacomitinib 45 mg n=113 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 45 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.	Dacomitinib Other Dose n=1 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, twice daily or 15 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.
Number of Participants With AEs: Chinese Participants With Common EGFR Mutation	60 Participants	67 Participants	0 Participants

SECONDARY outcome

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

Population: 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 Chinese participants with common EGFR mutation evaluable for this outcome measure.

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.

Outcome measures

Measure	Dacomitinib 30 mg n=133 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.	Dacomitinib 45 mg n=113 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 45 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.	Dacomitinib Other Dose n=1 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, twice daily or 15 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.
Number of Participants Classified According to Starting Dose of Dacomitinib as First-line Therapy: Chinese Participants With Common EGFR Mutation 45 mg once daily	0 Participants	113 Participants	0 Participants
Number of Participants Classified According to Starting Dose of Dacomitinib as First-line Therapy: Chinese Participants With Common EGFR Mutation Other dose	0 Participants	0 Participants	1 Participants
Number of Participants Classified According to Starting Dose of Dacomitinib as First-line Therapy: Chinese Participants With Common EGFR Mutation 30 mg once daily	133 Participants	0 Participants	0 Participants

SECONDARY outcome

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

Population: 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 Chinese participants with common EGFR mutation evaluable for this outcome measure.

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.

Outcome measures

Measure	Dacomitinib 30 mg n=133 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.	Dacomitinib 45 mg n=113 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 45 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.	Dacomitinib Other Dose n=1 Participants Participants who initiated treatment with dacomitinib as first line therapy at a dose of 30 mg, twice daily or 15 mg, once daily in a real world setting under routine clinical practice outside of clinical trials were included.
Number of Participants Without Oral Dose Modifications: Chinese Participants With Common EGFR Mutation	111 Participants	55 Participants	1 Participants

Adverse Events

Dacomitinib 30 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 64 deaths

Dacomitinib 45 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 49 deaths

Dacomitinib Other Dose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER