Lorlatinib Phase IV Trial Results for ALK-Positive NSCLC

71 patients with ALK-positive metastatic non-small cell lung cancer were treated with lorlatinib in this post-approval phase IV study. The dataset includes efficacy outcomes like a 42% objective response rate and 12.2-month median progression-free survival, plus safety data on adverse events. It was authored by Alessandra Bearz and published on figshare in April 2026.

Use Cases

• Analyze the relationship between prior ALK inhibitor (alectinib vs. ceritinib) and subsequent objective response rate to lorlatinib.
• Model progression-free survival (12.2-month median) based on patient subgroups, such as those with central nervous system metastases.
• Correlate treatment-emergent adverse event rates (97% any-grade, 39% grade≥3) with clinical outcomes like dose interruption (31%) or reduction (15%).
• Compare intracranial objective response rate (47% in 30 patients) with overall response rate for patients with brain metastases.

Strengths

• 71 patient records from a defined phase IV clinical trial (NCT04362072).
• Reports multiple specific clinical endpoints: 42% ORR, 12.2-month median PFS, 9.7-month median treatment duration.
• Includes detailed safety data with percentages for adverse events and dose modifications.

Limitations

• Small sample size of 71 patients limits statistical power for subgroup analyses.
• Data is presented in aggregate summary form (DOCX/JPG), not as individual patient-level records.
• Temporal coverage and patient recruitment geography are not specified.

Provenance

Source

Clinical trial results published on figshare by author Alessandra Bearz.

Collection Method

Data collected from a phase IV open-label, single-arm post-approval clinical study.

Freshness

Last updated April 2026, representing recent clinical trial results.