N/A
N=161
Anaplastic Lymphoma Kinase (ALK)-Positive Non-small Cell Lung Cancer (NSCLC) Post-alectinib Treatment Patterns
Non-Small-Cell Lung Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT04351334 ↗Enrolled (actual)
161
Serious AEs
—
Results posted
Sep 2024
Primary outcome: Primary: Number of Participants Classified According to Treatments Received for Anaplastic Lymphoma Kinase Positive-non-Small Cell Lung Cancer (ALK + NSCLC) in Sequence — 103; 8; 23; 1 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Alectinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Classified According to Treatments Received for Anaplastic Lymphoma Kinase Positive-non-Small Cell Lung Cancer (ALK + NSCLC) in Sequence |
103; 8; 23; 1; 2; 15 | — |
| PRIMARY Number of Participants Classified According to Reason for Alectinib Treatment Discontinuation |
7; 13; 15; 55; 1; 1 | — |
| PRIMARY Duration of Therapy (DOT) |
23.9 | — |
| PRIMARY Overall Survival (OS) |
46.3 | — |
| PRIMARY Progression Free Survival (PFS) |
41.4 | — |
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
- Patients with a documented diagnosis of NSCLC.
- Patients ≥ 18 years of age at initial recorded diagnosis of NSCLC.
- 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.
- During the study observation period, patients observed with at least 2 visits after the index date-1.
Exclusion Criteria
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT04351334). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.