The Absolute Effect / Oncology Evidence / Evidence Index
ALTA-1L
In ALK-inhibitor-naive advanced ALK-positive NSCLC, does brigatinib improve progression-free survival over crizotinib?
Registry: NCT02737501 · Evidence reviewed 9 November 2026 · Aliases and follow-up publications consolidated.
Phase III randomized; n=275.Primary-source evidence summaryStudy design, population and eligibility
Phase III randomized; n=275.
ALK-inhibitor-naive locally advanced/metastatic ALK-positive NSCLC.
Treatment and comparator
Intervention: Brigatinib 90 mg daily 7-day lead-in then 180 mg daily.
Comparator: Crizotinib 250 mg twice daily.
Endpoints
PFS by BICR primary.
Key efficacy and clinical outcomes
At second interim: median PFS 24.0 vs 11.0 mo (HR 0.49); final analysis 3-y PFS 43% vs 19%.
Source-reported outcome visualization
Values are reproduced from the cited report; bars are scaled within this figure. First-line ALK-positive advanced NSCLC
Median survival and hazard ratios are not fixed-time event risks; NNT is not inferred from them.
Toxicity and treatment burden
Early pulmonary events, hypertension, CPK/lipase elevation and hepatotoxicity; follow lead-in dosing.
Absolute effect and NNT/NNH
Crizotinib comparator; cross-trial comparisons with CROWN are invalid.
NNT/NNH is not calculated unless a directly reported, comparable fixed-time risk difference supports it. Median survival and hazard ratios alone do not provide an NNT.
Critical interpretation and limitations
Crizotinib comparator; cross-trial comparisons with CROWN are invalid.
This page is an evidence summary, not a substitute for multidisciplinary assessment or patient-specific decision-making.
Current-practice context
Review date: 9 November 2026. Primary publication and selected follow-up sources were reviewed. Full disease-specific guideline, regulatory-label and sequencing audit remains pending; verify current local recommendations and biomarker eligibility before clinical application.