N/A
N=299
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
Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04609319 ↗Enrolled (actual)
299
Serious AEs
—
Results posted
May 2025
Primary outcome: Primary: Body Mass Index (BMI): All Asian Participants — 22.6; 23.1; 26.4 Kilogram per square meter
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Dacomitinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Body Mass Index (BMI): All Asian Participants |
22.6; 23.1; 26.4 | — |
| PRIMARY Number of Participants Classified According to Smoking Status: All Asian Participants |
2; 11; 0; 24; 41; 1 | — |
| PRIMARY Number of Participants Classified According to Comorbidities: All Asian Participants |
44; 22; 1; 97; 109; 1 | — |
| PRIMARY Number of Participants Classified According to NSCLC Staging: All Asian Participants |
6; 8; 2; 0; 4; 0 | — |
| PRIMARY Number of Participants Classified According to Eastern Cooperative Oncology Group (ECOG) Performance Status: All Asian Participants |
20; 11; 0; 59; 80; 0 | — |
| PRIMARY Number of Participants Classified According to Type of EGFR Mutation: All Asian Participants |
54; 36; 1; 102; 89; 1 | — |
| PRIMARY Number of Participants Classified According to Number of Oral Dose Modifications: All Asian Participants |
128; 67; 1; 16; 41; 0 | — |
| PRIMARY Number of Participants Classified According to Number of Oral Dose Interruptions: All Asian Participants |
142; 115; 1; 10; 20; 0 | — |
| PRIMARY Number of Participants With Any Oral Dose Discontinuation: All Asian Participants |
116; 105; 2 | — |
| PRIMARY Duration of Dacomitinib Therapy: All Asian Participants |
17.4; 16.6; 14.9 | — |
| PRIMARY Time To Treatment Failure (TTF): All Asian Participants |
15.8; 17.7; 14.5 | — |
| SECONDARY Progression-free Survival (PFS): All Asian Participants |
18.3; 21.0; 14.5 | — |
| SECONDARY Number of Participants With Adverse Events (AEs): All Asian Participants |
79; 82; 1 | — |
| SECONDARY TTF: Chinese Participants With Common EGFR Mutation |
17.3; 18.9; NA | — |
| SECONDARY PFS: Chinese Participants With Common EGFR Mutation |
20.3; 21.2; NA | — |
| SECONDARY Number of Participants With AEs: Chinese Participants With Common EGFR Mutation |
60; 67; 0 | — |
| SECONDARY Number of Participants Classified According to Starting Dose of Dacomitinib as First-line Therapy: Chinese Participants With Common EGFR Mutation |
133; 0; 0; 0; 113; 0 | — |
| SECONDARY Number of Participants Without Oral Dose Modifications: Chinese Participants With Common EGFR Mutation |
111; 55; 1 | — |
Summary
This is a longitudinal, consecutive case-series, multi-center study with mixed prospective and retrospective data collection. Data will be collected from eligible adults with EGFR mutation-positive advanced non-small cell lung cancer (NSCLC) treated with dacomitinib as first-line therapy from the date of advanced NSCLC diagnosis to the date of death, lost to follow-up, withdrawal of consent or end of study, whichever occurs first.
Eligibility Criteria
Inclusion Criteria
- Adult (aged ≥18 years) with histology-confirmed advanced NSCLC (TNM stage IIIB-IV);
- Presence of any EGFR-activating mutation (exon 19 deletion or exon 21 L858R substitution) or other uncommon EGFR mutations prior to anti-cancer treatment;
- Initiating dacomitinib as first-line treatment after confirmation of EGFR-mutation status (ie, no prior treatment with other EGFR TKI or systemic therapy);
Exclusion Criteria
- Enrolled in any interventional clinical study or trial (however, patients enrolled in non-interventional, real world study may still be included).
Data sourced from ClinicalTrials.gov (NCT04609319). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.