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Ramucirumab Plus Pembrolizumab vs Usual Care for Treatment of Stage IV or Recurrent Non-Small Cell Lung Cancer Following Immunotherapy, Pragmatica-Lung Study

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date changed from estimate of Jan 15, 2027 to Nov 26, 2025 Site details revised at 2 of 566 sitesv13 Show 1 more changeShow less
    • Site details revised at 2 of 566 sites
  2. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 700 to confirmed 838 · Site details revised at 566 of 566 sitesv12 Show 2 more changesShow less
    • Enrollment target: estimated 700 to confirmed 838
    • Site details revised at 566 of 566 sites
  3. Primary completion date: Mar 15, 2025 to Jan 15, 2027v11
  4. Study sites: 441 to 566v10
  5. Study sites: 139 to 441v9
Show 7 earlier versionsHide 7 earlier versions
  1. Start date: Mar 6, 2023 to Mar 14, 2023v8
  2. Study sites: 77 to 139v7
  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 77 · Start date changed from estimate of Mar 15, 2023 to Mar 6, 2023v6 Show 2 more changesShow less
    • Study sites: 0 to 77
    • Start date changed from estimate of Mar 15, 2023 to Mar 6, 2023
  4. Primary completion date: Dec 15, 2024 to Mar 15, 2025 Completion date: Dec 15, 2029 to Mar 15, 2028v5 Show 1 more changeShow less
    • Completion date: Dec 15, 2029 to Mar 15, 2028
  5. Start date: Jan 16, 2023 to Mar 15, 2023v4
  6. Start date: Dec 15, 2022 to Jan 16, 2023 Collaborators: 1 to 3 · Study title revisedv3 Show 2 more changesShow less
    • Collaborators: 1 to 3
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  7. Study title shortened, about 3 wordsv2 See this version in full on ClinicalTrials.gov ↗
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This phase III trial compares the effect of the combination of ramucirumab and pembrolizumab versus standard of care chemotherapy for the treatment of non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs 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. This trial may help doctors find out if giving ramucirumab with pembrolizumab is more effective at treating patients with stage IV or recurrent non-small cell lung cancer than standard chemotherapy.
Trial Details
NCT Number NCT05633602
Lead Sponsor SWOG Cancer Research Network
Collaborators: National Cancer Institute (NCI), Eli Lilly and Company, Merck Sharp & Dohme LLC
Conditions Recurrent Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8
Enrollment 838 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov