Anaplastic Lymphoma Kinase (ALK)-Positive Non-small Cell Lung Cancer (NSCLC) Post-alectinib Treatment Patterns
NCT04351334
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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1-800-718-1021
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.
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.
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Descriptive Information | |||||
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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 | 1 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | December 31, 2020 | ||||
Estimated Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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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 |
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Responsible Party | Pfizer | ||||
Study Sponsor | Pfizer | ||||
Collaborators | Not Provided | ||||
Investigators |
| ||||
PRS Account | Pfizer | ||||
Verification Date | September 2020 |