Author of

• 20183

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  P3.04 - Clinical Design, Statistics and Clinical Trials (ID 720)

  • Event: WCLC 2017
  • Type: Poster Session with Presenters Present
  • Track: Clinical Design, Statistics and Clinical Trials
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/18/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)

  • 24085

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    P3.04-009 - Stereotactic Body Radiotherapy to All Sites of Oligometastatic Non-Small Cell Lung Cancer (NSCLC) Combined with Durvalumab and Tremelimumab (ID 10441)

    09:30 - 09:30  |  Author(s): K. Matkowskyj
    • Abstract

    Background:
    PD-1/PD-L1 axis inhibition and comprehensive stereotactic body radiation (SBRT) treatment to all gross disease have both been independently associated with improved outcomes for patients with oligometastatic NSCLC in randomized trials. Interest has increased in the use of dual immune checkpoint inhibition in NSCLC, which adds targeting of CTLA-4 to PD-1/PD-L1 inhibition, as this has showed improved outcomes in melanoma, though with increased side effects. Recent appreciation for the immunostimulatory effects of SBRT and possible synergy with checkpoint inhibition therapies has prompted interest in combining these treatments, however the toxicity of this combination is unknown. This is the first trial evaluating the sequential combination of comprehensive SBRT and dual immune checkpoint inhibition.
    
    Method:
    This phase I trial will assess the safety and preliminary outcomes for a 21 patient cohort undergoing SBRT to all sites of oligometastatic (EGFR/ALK wildtype) NSCLC followed by combined duvalumab and tremelimumab immune checkpoint inhibition. Patients with 1-6 extracranial sites of disease will undergo SBRT from 30-50 Gy in 5 fractions. One week after radiation they will receive 4 cycles of combination Durvalumab 1500mg/Tremelimumab 75mg every 4 weeks followed by Durvalumab 1500mg monotherapy q 4 weeks. The primary endpoint of this study is safety. Secondary endpoints include overall survival (OS) and (PFS). Correlative studies of PD-L1 expression on post SBRT biopsy and circulating tumor cells are incorporated into the protocol.
    
    Result:
    Section not applicable
    
    Conclusion:
    The study is currently undergoing IRB review and FDA IND approval. This study will open to accrual in August 2017.