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Adjuvant targeted therapy (for patients with stage IB NSCLC and EGFR variants)
Source: Non-Small Cell Lung Cancer Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: May 15, 2025 · Captured 2026-09-09.
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Adjuvant targeted therapy with osimertinib for patients with resected stage IB to IIIA NSCLC and an EGFR pathogenic variant was studied in a phase III clinical trial and showed improved OS.
Evidence (adjuvant targeted therapy with osimertinib for patients with stage IB NSCLC and EGFR variants):
The phase III, double-blind, placebo-controlled ADAURA (NCT02511106) trial included 682 patients with surgically resected stage IB to stage IIIA NSCLC and EGFR pathogenic variants (centrally determined, deletion in exon 19 or L858R variant). Patients were randomly assigned to receive either 80 mg of osimertinib by mouth daily (n = 399) or a placebo (n = 342) for 3 years. Standard postoperative adjuvant chemotherapy was allowed but not mandatory; decisions regarding adjuvant chemotherapy were made by the physician and patient before trial enrollment.[12][Level of evidence A1]
Source links and citations
The phase III, double-blind, placebo-controlled ADAURA (NCT02511106) trial included 682 patients with surgically resected stage IB to stage IIIA NSCLC and EGFR pathogenic variants (centrally determined, deletion in exon 19 or L858R variant). Patients were randomly assigned to receive either 80 mg of osimertinib by mouth daily (n = 399) or a placebo (n = 342) for 3 years. Standard postoperative adjuvant chemotherapy was allowed but not mandatory; decisions regarding adjuvant chemotherapy were made by the physician and patient before trial enrollment.[12][Level of evidence A1]
In the overall population, the 5-year OS rate was 88% in the osimertinib group and 78% in the placebo group (overall HRdeath, 0.49; 95.03% CI, 0.34–0.70; P < .001).
The phase III, double-blind, placebo-controlled ADAURA (NCT02511106) trial included 682 patients with surgically resected stage IB to stage IIIA NSCLC and EGFR pathogenic variants (centrally determined, deletion in exon 19 or L858R variant). Patients were randomly assigned to receive either 80 mg of osimertinib by mouth daily (n = 399) or a placebo (n = 342) for 3 years. Standard postoperative adjuvant chemotherapy was allowed but not mandatory; decisions regarding adjuvant chemotherapy were made by the physician and patient before trial enrollment.[12][Level of evidence A1]
Among patients with stage II to IIIA disease, the 5-year OS rate was 85% in the osimertinib group and 73% in the placebo group (overall HRdeath, 0.49; 95.03% CI, 0.33–0.73; P < .001).
The phase III, double-blind, placebo-controlled ADAURA (NCT02511106) trial included 682 patients with surgically resected stage IB to stage IIIA NSCLC and EGFR pathogenic variants (centrally determined, deletion in exon 19 or L858R variant). Patients were randomly assigned to receive either 80 mg of osimertinib by mouth daily (n = 399) or a placebo (n = 342) for 3 years. Standard postoperative adjuvant chemotherapy was allowed but not mandatory; decisions regarding adjuvant chemotherapy were made by the physician and patient before trial enrollment.[12][Level of evidence A1]
The adverse event profile is consistent with other studies that used osimertinib except for pneumonia related to COVID-19, which was reported later.
The U.S. Food and Drug Administration (FDA) approved osimertinib as adjuvant therapy for patients with stage IB to IIIA NSCLC with EGFR exon 19 deletions or EGFR L858R variants.
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Preserved source evidence · Not medical advice