Author of

• 12592

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  P3.10 - Poster Session 3 - Chemotherapy (ID 210)

  • Event: WCLC 2013
  • Type: Poster Session
  • Track: Medical Oncology
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/30/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 12595

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    P3.10-003 - A randomized Phase 2 trial of pemetrexed (P) and gefitinib (G) versus G as first-line treatment for patients with stage IV non-squamous (NS) non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations (ID 223)

    09:30 - 09:30  |  Author(s): H. Barraclough
    • Abstract

    Background
    G has been established as a standard first-line therapy in patients with advanced NSCLC harboring activating EGFR mutations. Results from preclinical and clinical studies have shown synergistic cytotoxic effects of EGFR tyrosine kinase inhibitors and P, and that P is a key cytotoxic agent for NS NSCLC. Therefore, combination of P and G may offer benefits that exceed the inhibition of tumor progression with G monotherapy in patients with NS NSCLC harboring activating EGFR mutations.

    Methods
    This randomized, multicenter, open-label, parallel-arm, Phase 2 East-Asian study has been initiated to test the hypothesis that G + P will prolong progression-free survival (PFS) compared to G in patients with NS NSCLC with EGFR mutation. Eligible patients must have stage IV NS NSCLC, an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1 and an activating EGFR mutation. Approximately 188 patients will be randomized in a 2:1 ratio (G+P:G) stratified by gender, ECOG PS and prior neo-/adjuvant treatment. Study treatment will continue until progression, unacceptable toxicity or another discontinuation criterion is met. Patients in the G + P arm are required to take prophylactic folic acid and vitamin B~12~ supplementation as stated on the P label. With a one-sided significance level of 0.2, 145 events (objective disease progression/death) will provide 70% power, assuming a true hazard ratio of 0.79 (about 26% prolongation in PFS time). It is expected that 145 events will be observed if 188 pts are enrolled within an accrual period of 12 months and followed-up over 18 months. The primary endpoint of PFS will be analyzed after 145 events have been observed by using a multivariate Cox model. Secondary endpoints include time to progressive disease, overall survival (OS), overall response rate, disease control rate, duration of response, biomarkers and treatment-emergent adverse events. To ensure mature OS data, the criteria to end the study will be the earlier of 130 OS events or 30 months from the last patient entered treatment milestone. Enrollment started in early 2012. The trial is sponsored by Eli Lilly and Company (NCT01469000).

    Results
    Not Applicable.

    Conclusion
    Not Applicable.