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P1.01 - Advanced NSCLC (Not CME Accredited Session) (ID 933)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Presentations: 1
- Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
P1.01-88 - Osimertinib Maintenance After Definitive Chemoradiation in Patients with Unresectable EGFRm-Positive Stage III NSCLC (LAURA) (ID 13684)
16:45 - 18:00 | Author(s): Helen Mann
The standard of care for patients with stage III unresectable NSCLC is definitive platinum-based chemoradiation, regardless of epidermal growth factor receptor mutation (EGFRm) status. There is evidence that following chemoradiation, patients with EGFRm-positive NSCLC have superior local control but inferior distant control, including an increased incidence of CNS metastases, compared with patients with EGFR wild type (EGFRwt)-NSCLC. This supports the rationale for evaluation of EGFR tyrosine kinase inhibitor (TKI) maintenance in EGFRm-positive patients without disease progression following chemoradiation. Osimertinib is a third-generation, CNS-active EGFR-TKI that potently and selectively inhibits both sensitizing EGFR and T790M mutations. It has shown superior progression-free survival (PFS) vs. standard EGFR-TKIs in first-line treatment of patients with EGFRm-positive advanced NSCLC, including patients with or without CNS metastases at trial entry.1 These data further support the rationale for evaluation of osimertinib in the even earlier disease setting of EGFR-TKI-naïve stage III NSCLC following definitive chemoradiation where it has the potential to prevent/delay progression, including in the CNS, and improve survival compared with chemoradiation alone.a9ded1e5ce5d75814730bb4caaf49419 Method
LAURA is a double-blind, randomized, placebo-controlled, multicenter, phase 3 study designed to assess efficacy and safety of osimertinib as maintenance therapy in patients with locally advanced, unresectable, EGFRm-positive, stage III NSCLC without disease progression following definitive platinum-based chemoradiation therapy. All patients will have tumors bearing exon 19 deletion or L858R mutation (centrally or locally confirmed by cobas®EGFR Mutation Test v2), age >18 years, and a WHO performance status of 0-1. Patients will have received prior concurrent (CCRT) or sequential (SCRT) chemoradiation treatment (including ≥2 cycles of platinum-based chemotherapy and radiation of 60 Gy ±10% [54-66 Gy]). Key exclusion criteria include a history of interstitial lung disease, symptomatic pneumonitis following chemoradiation, other unresolved toxicity >Grade 2, cardiac abnormalities, and inadequate organ function. Approximately 200 patients will be randomized 2:1 to osimertinib 80 mg oral once daily or placebo, within 6 weeks of completion of chemoradiation, until disease progression. Stratification factors are prior chemoradiation strategy (CCRT vs SCRT), tumor stage (IIIA vs IIIB/IIIC), and China vs non-China. The primary endpoint is RECIST 1.1 assessed PFS based on blinded independent central review (BICR). Key secondary endpoints include time to CNS PFS, overall survival, objective response rate, disease-related symptoms and health-related QoL, safety and tolerability, and pharmacokinetics. Study enrollment will commence from July 2018.
1Soria et al N Engl J Med 2018; 378:113-1254c3880bb027f159e801041b1021e88e8 Result
Section not applicable8eea62084ca7e541d918e823422bd82e Conclusion
Section not applicable6f8b794f3246b0c1e1780bb4d4d5dc53
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