Author of

• 20168

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  P2.04 - Clinical Design, Statistics and Clinical Trials (ID 705)

  • Event: WCLC 2017
  • Type: Poster Session with Presenters Present
  • Track: Clinical Design, Statistics and Clinical Trials
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)

  • 23330

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    P2.04-001 - BALTIC: A Phase 2, Open-Label Study of Novel Combinations of Immunotherapies or DDR Inhibitors in Platinum-Refractory ED-SCLC (ID 8668)

    09:30 - 09:30  |  Presenting Author(s): Ihor Vynnychenko
    • Abstract
    • Slides

    Background:
    Immunotherapy and DNA damage repair inhibitors have the potential to play a role in the treatment of patients with extensive-disease small cell lung cancer (ED-SCLC), due to high mutation load and genomic instability in this disease setting. Durvalumab, a selective, high-affinity, engineered human IgG1 mAb blocks PD-L1 binding to PD-1 and CD80. Tremelimumab is a selective human IgG2 mAb targeting CTLA-4. Durvalumab plus tremelimumab demonstrated clinical activity and manageable tolerability in a Phase 1b study in NSCLC (NCT02000947). AZD1775, a small-molecule inhibitor of DNA damage checkpoint kinase WEE1, potentiates genotoxic chemotherapies. AZD1775 plus carboplatin showed antitumor activity and acceptable safety in a Phase 2 study in platinum-refractory p53-mutated ovarian cancer (NCT01164995).
    
    Method:
    BALTIC (NCT02937818) is a Phase 2, open-label, multicenter, multi-arm, exploratory, signal-searching study to assess the preliminary activity of novel treatment combinations in patients with platinum-refractory/resistant ED-SCLC. Inclusion criteria include disease progression during, or within 90 days of completing, first-line platinum-based chemotherapy; WHO/ECOG performance status of 0/1; and life expectancy ≥8 weeks. Each study arm is independent and will open sequentially to enroll up to 20 patients. The study will open initially with two arms. Patients will receive durvalumab 1500 mg + tremelimumab 75 mg i.v. q4w for 4 doses, followed by durvalumab monotherapy 1500 mg i.v. q4w (Arm A); and oral AZD1775 225 mg bid for 2.5 days from Day 1 + carboplatin AUC 5 on Day 1 i.v. q3w (Arm B). Treatment will continue until confirmed disease progression or discontinuation. Further arms will be added to assess other combinations once tolerable dosing regimens have been established. The primary endpoint is investigator-assessed ORR (RECIST v1.1). Secondary endpoints include duration of response, disease control rate, time-to-response, PFS, OS, pharmacokinetics, safety and tolerability. Gene expression levels and biomarkers will also be explored. Recruitment is ongoing.Figure 1
    
    
    
    Result:
    Section not applicable
    
    Conclusion:
    Section not applicable
    
    

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