Clinical trial NCT04351334: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Small-Cell Lung Carcinoma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-04-17
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of patients with a diagnosis of NSCLC receiving 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.


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 during the study identification period, including those who initiated alectinib prior (index date-1) to the start of 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.

Primary outcomes:
measure: Number of Participants Classified According to Treatments Received for Anaplastic Lymphoma Kinase Positive-non-Small Cell Lung Cancer (ALK + NSCLC) in Sequence
timeFrame: During the inclusion period from 01-Jun-2017 to 31-Aug-2020 (maximum up to 39 months); eligible data was studied during approximately 31 months of this retrospective study
measure: Number of Participants Classified According to Reason for Alectinib Treatment Discontinuation
timeFrame: From initiation of index treatment to discontinuation from 01-Jun-2017 to 31-Aug-2021 (maximum up to 51 months); eligible data was studied during approximately 31 months of this retrospective study
measure: Duration of Therapy (DOT)
timeFrame: Alectinib or post-alectinib treatment initiation till its discontinuation or censoring date, during study observation period (maximum up to 51 months); eligible data was studied during approximately 31 months of this retrospective study
measure: Overall Survival (OS)
timeFrame: From start of treatment until date of death or censoring date, during study observation period (maximum up to 51 months); eligible data was studied during approximately 31 months of this retrospective study
measure: Progression Free Survival (PFS)
timeFrame: From initiation of index treatment to date of progression or death due to any cause or censoring date, during study observation period (maximum up to 51 months); eligible data was studied during approximately 31 months of this retrospective study
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Pfizer Inc
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: