FLAURA2

In first-line EGFR-mutated advanced NSCLC, does osimertinib plus platinum–pemetrexed improve survival over osimertinib alone?

Evidence snapshot updated 23 October 2026. Source links are provided below; this is an evidence summary, not a substitute for current local guidelines or individual clinical judgement.

Population and treatment

557 patients with untreated advanced NSCLC harbouring common sensitizing EGFR mutations.

Intervention and comparator: Osimertinib 80 mg orally daily plus pemetrexed and platinum for 4 cycles, followed by osimertinib plus pemetrexed maintenance, versus osimertinib 80 mg daily alone.

ClinicalTrials.gov: NCT04035486 ↗

Key results

Median OS 47.5 vs 37.6 months; HR for death 0.77 (95% CI 0.61–0.96; P=.02). At 36 months, OS estimates were 63.1% vs 50.9%. Grade ≥3 adverse events of any cause were 70% vs 34%.

Overall survival · Median follow-up 51 months; median OS endpoint

Absolute-effect interpretation: Median OS difference 9.9 months is not an NNT. At 36 months, the reported OS estimates differ by 12.2 percentage points; this is a fixed-time estimate and approximate reciprocal can be shown only with the time horizon explicit.

Toxicity and treatment burden

Combination therapy substantially increases grade ≥3 adverse events, mainly chemotherapy-associated; monitor cytopenias, renal function, pemetrexed suitability, QTc, cardiac function and interstitial lung disease symptoms.

Interpretation and limitations

FLAURA2 is distinct from FLAURA (osimertinib vs first-generation EGFR TKIs). The comparison is combination therapy versus osimertinib monotherapy; weigh additional disease control against infusion burden, chemotherapy toxicity and patient preference.

Use endpoint definitions, follow-up, analysis population and comparator exactly as reported. Do not infer NNT from a hazard ratio or median survival. Subgroup findings should not be treated as predictive unless the trial design and interaction testing support that interpretation.

Primary source and further reading

Primary publication / authoritative source ↗

Trial registry (NCT04035486) ↗

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