Continuous Talazoparib Plus Intermittent Low-Dose Temozolomide in Lung Cancer Patients

A Phase 2 Study of Continuous Talazoparib Plus Intermittent Low- Dose Temozolomide in Patients with Relapsed or Refractory Extensive-Stage Small Cell Lung Cancer

  • Clinical Trial Information

    Trial Contact: De Leon, Ma Theresa; Deronvil, France

    Trial Phone: 321.841.8284 ; 321.841.3498

  • IRB No: WIRB 20182286

    Protocol Abbrev: TRIO US L-07

    Principal Investigator: Tirrell Tremayne Johnson, MD

    Phase: Drug: Phase II

    Age Group: Adult

    Secondary Protocol No: TRIO-US L-07

    Treatment: Talazoparib Temozolomide

    Therapies Involved: Medication ID: NCT03672773

  • Objective

    - Evaluate the efficacy of talazoparib in combination with temozolomide as measured by objective response rate (ORR).
    - To evaluate the efficacy of talazoparib plus temozolomide as measured by progression-free survival (PFS), overall survival, duration of response, and time to response.

  • Key Eligibility

    1. =18 years of age
    2. Cytologically or histologically confirmed SCLC with extensive-stage disease;
    3. Relapsed (progressed within 6 months) or refractory (progressed during or within 4
    weeks of completing 1st line platinum based regimen);
    4. Measurable disease, as per RECIST 1.1;
    5. Archival or fresh tissue biopsy available for exploratory analyses;
    6. ECOG performance status of =1;
    7. Have adequate organ function:
    - Absolute neutrophil count (ANC) >1.5x109 /L
    - Platelets >100x109 /L
    - Hemoglobin >9 g/dL without transfusion or EPO dependency (within 7 days of assessment)
    - Glomerular filtration rate > 30 mL/min
    - Serum total bilirubin <1.5 X ULN OR Direct bilirubin < ULN for participants with total bilirubin levels >1.5 ULN
    - AST (SGOT) and ALT (SGPT) < 2.5 X ULN OR < 5 X ULN for participants with liver metastases
    - INR or PT and Activated Partial Thromboplastin Time (aPTT) <1.5 X ULN unless participant is receiving anticoagulant therapy, as long as PT or PTT is within therapeutic range of intended use ofanticoagulants