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
Last updated date
ABOUT THIS STUDY
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 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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Lung Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Enrolled in any interventional clinical study or trial (however, patients enrolled in
non-interventional, real world study may still be included).
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Advanced Information
| Descriptive Information | |||||
|---|---|---|---|---|---|
| Brief Title | 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 | ||||
| Official Title | 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 | ||||
| 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 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. | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Other | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Tertiary cancer-treating hospitals in China, India and Malaysia are planned as participating sites. | ||||
| Condition | Lung Cancer | ||||
| Intervention | Drug: Dacomitinib
This is a non-interventional, real world study of Asian patients being treated with dacomitinib as first-line treatment for EGFR+ NSCLC | ||||
| Study Groups/Cohorts | Cohort 1
Intervention: Drug: Dacomitinib | ||||
| Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
| Recruitment Information | |||||
| Recruitment Status | Not yet recruiting | ||||
| Estimated Enrollment | 300 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | November 30, 2024 | ||||
| Estimated Primary Completion Date | November 30, 2024 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| ||||
| Sex/Gender |
| ||||
| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts |
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| Listed Location Countries | Not Provided | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04609319 | ||||
| Other Study ID Numbers | A7471067 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
| ||||
| IPD Sharing Statement |
| ||||
| Responsible Party | Pfizer | ||||
| Study Sponsor | Pfizer | ||||
| Collaborators | Not Provided | ||||
| Investigators |
| ||||
| PRS Account | Pfizer | ||||
| Verification Date | March 2021 | ||||