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Lung-MAP: Nivolumab With or Without Ipilimumab as Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer and No Matching Biomarkers

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

Record History

  1. Completion date: Apr 1, 2026 to Apr 1, 2027v18
  2. Completion date: Apr 1, 2025 to Apr 1, 2026v17
  3. Completion date: Apr 1, 2024 to Apr 1, 2025v16
  4. Completion date: Apr 1, 2023 to Apr 1, 2024v15
  5. Re-verified, no change to tracked fieldsv14
Show 12 earlier versionsHide 12 earlier versions
  1. Completion date: Apr 1, 2022 to Apr 1, 2023v13
  2. Results first posted: Jan 11, 2022 Primary endpoints: 4 to 1 · Enrollment target: estimated 350 to confirmed 275 · Primary completion date changed from estimate of Apr 1, 2022 to Dec 19, 2019 · 2 morev12 Show 5 more changesShow less
    • Primary endpoints: 4 to 1
    • Enrollment target: estimated 350 to confirmed 275
    • Primary completion date changed from estimate of Apr 1, 2022 to Dec 19, 2019
    • Start date: Dec 18, 2015 to Dec 29, 2015
    • Secondary endpoints revised (3)

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv11
  4. Trial status: Recruiting to Active, Not Recruiting Site details revised at 1207 of 1207 sitesv10 Show 1 more changeShow less
    • Site details revised at 1207 of 1207 sites
  5. Study sites: 1180 to 1207v9
  6. Re-verified, no change to tracked fieldsv8
  7. Primary completion date: Dec 2019 to Apr 1, 2022 Primary endpoints revised (4) · Study sites: 1165 to 1180 · Completion date: Dec 2021 to Apr 1, 2022 · 6 morev7 Show 9 more changesShow less
    • Primary endpoints revised (4)
    • Study sites: 1165 to 1180
    • Completion date: Dec 2021 to Apr 1, 2022
    • Start date: Dec 2015 to Dec 18, 2015
    • Interventions: Ipilimumab (Biological), Laboratory Biomarker Analysis (Other), Nivolumab (Biological) to Ipilimumab (Biological), Laboratory Biomarker Analysis (Other), Nivolumab (Biological), Quality-of-Life Assessment (Other), Questionnaire…
    • Eligibility criteria expanded, about 204 words
    • Secondary endpoints revised (3)
    • Study description expanded, about 41 words
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  8. Study sites: 1098 to 1165v6
  9. Completion date: Dec 2021 Study title expanded, about 1 wordv5 Show 1 more changeShow less
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  10. Study sites: 1072 to 1098v4
  11. Study sites: 1022 to 1072v3
  12. Primary completion date: Apr 2022 to Dec 2019v2
  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 randomized phase III trial compares nivolumab with ipilimumab and nivolumab alone in treating patients with stage IV squamous cell lung cancer that has come back after previous treatment. This is a "non-match" sub-study that includes all screened patients not eligible for a biomarker-driven sub-study. Monoclonal antibodies, such as nivolumab and ipilimumab, may be able to shrink tumors. It is not yet known whether nivolumab works better with or without ipilimumab in treating patients with squamous cell lung cancer.
Trial Details
NCT Number NCT02785952
Lead Sponsor SWOG Cancer Research Network
Collaborators: National Cancer Institute (NCI)
Conditions Recurrent Squamous Cell Lung Carcinoma, Stage IV Squamous Cell Lung Carcinoma AJCC v7
Enrollment 275 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov