Clinical trial · Observational
Study to Evaluate Clinical Real World Outcomes of Lorlatinib After Alectinib in ALK-Positive NSCLC Japanese Patients
Retrospective, Multicenter, Observational Study to Evaluate Clinical Real World Outcomes of Lorlatinib After Alectinib in ALK-Positive NSCLC Japanese Patients
NCT04979988CI-TRIAL-00075755completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the clinical real world outcomes of lorlatinib in second/later line setting anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) to TKI sequence sequence treatment after failure of alectinib as a first-line treatment in Japanese ALK positive non-small cell lung cancer (NSCLC).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ALK-positive Non-small-cell Lung Cancer | ALK-Positive Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lortlatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Japanese patients with ALK+ NSCLC who received lorlatinib
- description
- lorlatinib as the second-line or later therapy after failure of alectinib treatment as the firstline therapy
- interventionNames
- Drug: Lortlatinib
Primary outcomes (25)
- measure
- Age at Start of Lorlatinib Treatment
- timeFrame
- At initiation of lorlatinib treatment, anytime between 01-May-2019 to 31-Dec-2020 (approximately 20 months); retrospective data was retrieved and analyzed during 4 months of this observational study
- description
- Age at start of lorlatinib treatment was entered based on the data in medical chart. If there were no details about the applicable age, the age was calculated from the date of birth to the start date of lorlatinib treatment.
- measure
- Height at Start of Alectinib Treatment
- timeFrame
- At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed NSCLC, with any tumor, node and metastasis (TNM) stage. * Confirmed ALK gene rearrangement by any validated test. * Confirmed the treatment with alectinib in the first line setting as systemic therapy in the medical record. * Confirmed the start treatment with lorlatinib as the second/later-line therapy from 1st May 2019 to 31st December 2020. Exclusion Criteria: -Participating on any clinical trials of which final results has not yet been reported during the study period.
References
Publications (0)
Data not yet available
No reference posted for this study.