Talazoparib and Low-Dose Temozolomide in Treating Participants With Relapsed or Refractory Extensive-Stage Small Cell Lung Cancer

StatusActive, Not Recruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 12 months later Oct 1, 2026 → Oct 1, 2027
See other at-risk trials from Jonsson Comprehensive Cancer Center

Record History

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  1. Primary completion pushed from Oct 1, 2026 to Oct 1, 2027 Show 4 more changesShow less
    • Study completion pushed from Oct 1, 2027 to Oct 1, 2028
    • Secondary endpoints: details revised at 2 of 6 entries
    • Site details revised at 2 of 6 sites
    • Eligibility criteria expanded, about 2 words
  2. Primary completion date: Oct 1, 2025 to Oct 1, 2026
    • Study completion date: Oct 1, 2026 to Oct 1, 2027
    v15
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 28 to confirmed 35
    • Site details revised at 6 of 6 sites
    v14
  4. Re-verified, no change to tracked fieldsv13
  5. Primary completion date: Oct 1, 2024 to Oct 1, 2025
    • Study completion date: Oct 1, 2025 to Oct 1, 2026
    v12
Show 10 earlier versionsHide 10 earlier versions
  1. Trial status: Active, Not Recruiting to Recruiting
    • Primary completion date: Oct 1, 2023 to Oct 1, 2024
    • Study completion date: Oct 1, 2024 to Oct 1, 2025
    • Site details revised at 6 of 6 sites
    v11
  2. Primary completion date: Oct 1, 2022 to Oct 1, 2023
    • Study completion date: Oct 1, 2023 to Oct 1, 2024
    v10
  3. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Nov 1, 2022 to Oct 1, 2022
    • Study completion date: Nov 1, 2023 to Oct 1, 2023
    • Site details revised at 6 of 6 sites
    v9
  4. Primary completion date: Nov 1, 2021 to Nov 1, 2022
    • Study completion date: Nov 1, 2022 to Nov 1, 2023
    v8
  5. Primary completion date: Nov 1, 2020 to Nov 1, 2021
    • Study completion date: Nov 1, 2021 to Nov 1, 2022
    v7
  6. Study sites: 1 to 6v6
  7. Collaborators revised (2)v5
  8. Primary completion date: Nov 1, 2019 to Nov 1, 2020
    • Study completion date: Nov 1, 2020 to Nov 1, 2021
    v4
  9. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 1, 2018 to Oct 31, 2018
    • Site details revised
    v3
  10. Start date: Oct 1, 2018 to Nov 1, 2018
    • Primary completion date: Oct 1, 2019 to Nov 1, 2019
    • Study completion date: Oct 1, 2020 to Nov 1, 2020
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase II trial studies how effective talazoparib and temozolomide are for treating participants with extensive-stage small cell lung cancer that has come back after an initial chemotherapy treatment. Talazoparib, a PARP inhibitor, may stop the growth of tumor cells by preventing them from repairing their DNA. Chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving talazoparib and temozolomide may work better in treating participants with extensive-stage small cell lung cancer than either one alone.
Trial Details
NCT Number NCT03672773
Lead Sponsor Jonsson Comprehensive Cancer Center
Collaborators: Translational Research in Oncology, Pfizer
Conditions
(from sponsor)		 Recurrent Extensive Stage Small Cell Lung Carcinoma, Refractory Extensive Stage Small Cell Lung Carcinoma
Related terms Small Cell Lung Carcinoma
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov