Durvalumab and Lurbinectedin for the Treatment of Relapsed or Refractory Small Cell Lung Cancer

StatusActive, Not Recruiting
PhasePhase 2
Started

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Record History

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  1. Primary completion date changed from estimate of Sep 1, 2026 to Mar 2, 2026
    • Study completion moved earlier from May 1, 2031 to Sep 2, 2030
    • Eligibility criteria shortened, about 41 words
    • Secondary endpoints: details revised at 4 of 4 entries
  2. Re-verified, no change to tracked fieldsv16
  3. Primary completion date: May 19, 2027 to Sep 1, 2026
    • Study completion date: Apr 19, 2031 to May 1, 2031
    v15
  4. Primary endpoints: 2 to 1v14 Show 6 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 46 to confirmed 29
    • Secondary endpoints: details revised at 2 of 4 entries
    • Site details revised
    • Study arms: 1 to 2
    • Eligibility criteria expanded, about 2 words
  5. Re-verified, no change to tracked fieldsv13
Show 11 earlier versionsHide 11 earlier versions
  1. Primary completion date: Nov 1, 2025 to May 19, 2027
    • Study completion date: Nov 1, 2026 to Apr 19, 2031
    • Site contact updated
    v12
  2. Enrollment target: 106 to 46
    • Primary completion date: Nov 1, 2024 to Nov 1, 2025
    • Study completion date: Nov 1, 2025 to Nov 1, 2026
    • Site contact updated
    v11
  3. Study Identification, Study Status, Contacts/Locations, Referencesv10
  4. Primary completion date: Nov 1, 2023 to Nov 1, 2024
    • Study completion date: Nov 1, 2024 to Nov 1, 2025
    v9
  5. Interventions: Durvalumab (Biological), Lurbinectedin (Drug), Topotecan Hydrochloride (Drug) to Durvalumab (Biological), Lurbinectedin (Drug)v8 Show 4 more changesShow less
    • Study description shortened, about 89 words
    • Study arms: 2 to 1
    • Collaborators shortened, about 4 words
    • Study title shortened, about 2 words
  6. Re-verified, no change to tracked fieldsv7
  7. Trial status: Suspended to Recruiting
    • Site details revised
    v6
  8. Trial status: Recruiting to Suspended Sponsor's reason: To assess safety cohort per protocol design
    • Site details revised
    v5
  9. Enrollment target: 43 to 106v4 Show 6 more changesShow less
    • Primary endpoints: 1 to 2
    • Secondary endpoints: details revised at 4 of 4 entries
    • Study description expanded, about 71 words
    • Site contact updated
    • Study title revised
    • Eligibility criteria expanded, about 4 words
  10. Interventions: Durvalumab (Biological), Topotecan Hydrochloride (Drug) to Durvalumab (Biological), Lurbinectedin (Drug), Topotecan Hydrochloride (Drug)v3 Show 4 more changesShow less
    • Eligibility criteria expanded, about 12 words
    • Study description expanded, about 28 words
    • Study arms: 1 to 2
    • Study title expanded, about 2 words
  11. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 21, 2020 to Dec 4, 2020
    • Site details revised
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
Mayo Clinic
1,024 trials monitored
See 128 trials at risk
Lung Cancer
4,798 trials monitored
See 270 trials at risk
Small Cell Lung Cancer
564 trials monitored
See 34 trials at risk
This phase II trial studies the effects of durvalumab and lurbinectedin in treating patients with extensive stage small cell lung cancer that has come back (relapsed) or has not responded to previous treatment with chemotherapy and immunotherapy (refractory). Monoclonal antibodies, such as durvalumab, may interfere with the ability of tumor cells to grow and spread. Lurbinectedin is in a class of medications called alkylating agents. It works by slowing or stopping the growth of cancer cells in the body. Giving durvalumab and lurbinectedin may help kill more tumor cells and help patients live longer.
Trial Details
NCT Number NCT04607954
Lead Sponsor Mayo Clinic
Conditions
(from sponsor)		 Platinum-Resistant Lung Small Cell Carcinoma, Platinum-Sensitive Lung Small Cell Carcinoma, Recurrent Extensive Stage Lung Small Cell Carcinoma, Refractory Extensive Stage Lung Small Cell Carcinoma
Enrollment 29 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov