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

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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
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.
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- 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
 (submitted: October 23, 2020)
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:

  • 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).
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2021