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

NCT04609319 | Completed Results

• 1 other identifier: A7471067
• Study Type: observational
• Target: 307
• Locations: 3 countries
• Sites: 14

Brief Summary

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

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (11)

• 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.

  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.

  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.

  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).

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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

  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

  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

  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

  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

  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

Study Arms (1)

Cohort 1

Drug: Dacomitinib

Interventions

Dacomitinib DRUG

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

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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);

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (14)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location

The First Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510080, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

Location

Hunan Provincial Tumor Hospital

Changsha, Hunan, 410013, China

Location

The First hospital of Jilin University

Changchun, Jilin, 130021, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

Internal Medicine, Chinese Academy of Medical Sciences Cancer Hospital

Beijing, 100021, China

Location

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning Province, China

Location

Rajiv Gandhi Cancer Institute And Research Centre

New Delhi, DEL, 110085, India

Location

Tata Memorial Center, Kolkata

Kolkata, West Bengal, 700156, India

Location

Pantai Hospital Kuala Lumpur

Kuala Lumpur, 59100, Malaysia

Location

University Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

Location

Beacon Hospital

Petaling Jaya, 46050, Malaysia

Location

Related Publications (1)

• 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.

  PMID: 41365111 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Lung Neoplasms

Interventions

dacomitinib

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: October 30, 2020
• Study Start: June 11, 2021
• Primary Completion: May 28, 2024
• Study Completion: May 28, 2024
• Last Updated: May 31, 2025
• Results First Posted: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2); MY (3); CN (9)