Author of

• 10743

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  P1.10 - Poster Session 1 - Chemotherapy (ID 204)

  • Event: WCLC 2013
  • Type: Poster Session
  • Track: Medical Oncology
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/28/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 10798

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    P1.10-055 - Treatment rationale and study design for an open-label randomized phase II trial of gemcitabine and cisplatin with or without bevacizumab in EGFR wild-type non-squamous non-small-cell lung cancer (ID 207)

    09:30 - 09:30  |  Author(s): Y. Yang
    • Abstract

    Background
    EGFR wild-type non-squamous non-small-cell lung cancer (NSCLC) accounted for the majority of lung cancer patients, but the outcome of its first-line treatment was not satisfactory. INNOVATION study provided a new therapy perspective for those patients. EGFR wild-type subgroup analysis of this study revealed gemcitabine/cisplatin first-line chemotherapy plus bevacizumab showed significant advantage compare with gemcitabine/cisplatin alone (PFS 8.4m vs. 3.4m, OS 18.0 vs. 10.3m), which suggested that gemcitabine/cisplatin plus bevacizumab may be the preferred first-line therapy for EGFR wild-type non-squamous NSCLC. However, no other prospective trail has been preceded to confirm this conclusion in patients with EGFR wild-type non-squamous NSCLC. As a new type of anti-tumor angiogenesis monoclonal antibody, bevacizumab precisely targets VEGF to inhibit angiogenesis for continuous tumor control. We conduct this randomized phase II trial to investigate if gemcitabine/cisplatin first-line chemotherapy plus bevacizumab is a better treatment for advanced non-squamous NSCLC patients without EGFR mutations. This study will also explore plasma biomarkers of bevacizumab efficacy.

    Methods
    This is an open-label randomized (1:1) 2-arm phase II study. Stage IIIB/IV EGFR wild-type non-squamous NSCLC with performance status (PS) 0 or 1 will be included; patients who have received prior chemotherapy or radiotherapy will be excluded. Patients (N=40) will receive (1:1) gemcitabine/cisplatin orgemcitabine/cisplatinplus bevacizumab (chemotherapy up to 6 cycles) until disease progression, unacceptable toxicity, patient/physician decision to discontinue, or death. Patients in the control arm receive first-line gemcitabine/cisplatin (gemcitabine 1250mg/m[2] IV D1 and D8 plus cisplatin 75mg/m[2] IV D1, every 21-day cycle). Patients in the experimental arm receive gemcitabine/cisplatin plus bevacizumab (7.5 mg/kg IV D1, every 21-day cycle). At the time point of start of chemotherapy and six weeks after chemotherapy, peripheral blood of patients from both arms will be collected to detect plasma VEGF, VEGFR and VEGFR-2 level by ELISA. The primary endpoint is progression-free survival (PFS). Secondary endpoints include response rate, disease control rate, safety of bevacizumab and quality of life. Exploratory objective is biomarker analysis. Recruitment began in February 2013; the estimated final data collection for the primary endpoint is Aug 2014. Further details can be found on ClinicalTrials.gov (NCT01623102).

    Results
    not applicable

    Conclusion
    not applicable