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Trial record 1 of 1 for:    NCT04351334
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Anaplastic Lymphoma Kinase (ALK)-Positive Non-small Cell Lung Cancer (NSCLC) Post-alectinib Treatment Patterns

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ClinicalTrials.gov Identifier: NCT04351334
Recruitment Status : Active, not recruiting
First Posted : April 17, 2020
Last Update Posted : April 22, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date April 15, 2020
First Posted Date April 17, 2020
Last Update Posted Date April 22, 2021
Actual Study Start Date March 27, 2020
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 15, 2020)
  • Duration of therapy [ Time Frame: June 2017 to December 2019 ]
  • ALK TKI treatment patterns and sequencing [ Time Frame: June 2017 to December 2019 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 15, 2020)
  • Overall Survival [ Time Frame: June 2017 to December 2019 ]
  • Treatment discontinuation [ Time Frame: June 2017 to December 2019 ]
  • Progression free survival [ Time Frame: June 2017 to December 2019 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Anaplastic Lymphoma Kinase (ALK)-Positive Non-small Cell Lung Cancer (NSCLC) Post-alectinib Treatment Patterns
Official Title Patient Profiles and Treatment Patterns Among ALK-positive NSCLC Patients Treated With Alectinib
Brief Summary This study aims to understand patient profiles, treatment patterns, and clinical outcomes among ALK-positive NSCLC patients treated with alectinib, and post-alectinib treatment patterns and outcomes.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The study population will consist of patients with a diagnosis of NSCLC receiving alectinib within in the USON and Onmark.
Condition Non-Small-Cell Lung Carcinoma
Intervention Drug: Alectinib
Observational treatment based on physician choice
Study Groups/Cohorts Patients with ALK-positive NSCLC
Intervention: Drug: Alectinib
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 Active, not recruiting
Actual Enrollment
 (submitted: April 15, 2020)
1
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Patients with a documented diagnosis of NSCLC.
  2. Patients ≥ 18 years of age at initial recorded diagnosis of NSCLC.
  3. Patients who received treatment with alectinib within USON or Onmark during the study identification period.
  4. During the study observation period, patients observed with at least 2 visits after the index date-1.

Exclusion Criteria:

  1. Receipt of treatment indicated for another primary cancer or diagnosis of another primary cancer (with the exception of non-melanotic skin cancer), within 5 years of index date-1 will be excluded.
  2. Patients enrolled in clinical trials prior to receiving alectinib during the study ID period (index date-1), will be included and flagged in the analysis.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04351334
Other Study ID Numbers B7461031
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
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/data_requests.
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2021