LAURA

Does osimertinib improve disease control after chemoradiotherapy in unresectable EGFR-mutated stage III NSCLC?

Population and treatment

216 patients without progression after definitive chemoradiotherapy.

Intervention vs comparator: Osimertinib vs placebo after chemoradiotherapy.

Registry: https://pubmed.ncbi.nlm.nih.gov/?term=LAURA+osimertinib+stage+III+NSCLC

Results

Median PFS 39.1 vs 5.6 months; HR 0.16 (95% CI 0.10–0.24; p<0.001). 12-month PFS 74% vs 22%. Grade ≥3 AEs 35% vs 12%; mostly grade 1–2 pneumonitis 48% vs 38%. 2026 interim OS HR 0.67 (95% CI 0.40–1.14), 31% maturity; not conclusive.

Progression-free survival · 12 months

NNT: NCT03521154

NNH not calculated without a defensible fixed-time excess-harm risk. Never derive NNT from median survival or HR alone.

Toxicity and treatment burden

22

Full grade 3–5 toxicity, discontinuation, QoL and treatment exposure require primary report/supplement extraction before full clinical signoff. Missing rates are not imputed.

Interpretation and limitations

Distinct from FLAURA: LAURA is stage III after chemoradiotherapy. Approximate 12-month PFS NNT 2; OS remains immature/inconclusive. Do not derive NNT from median PFS.

Distinguish prespecified from exploratory subgroups, mature from immature endpoints, and superiority from non-inferiority. Verify current guidelines and individual eligibility.

Primary source

Primary publication / authoritative source

Source-level QoL, discontinuation, full toxicity and guideline currency audit remains a QC requirement.