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Split Course Adaptive Radiation Therapy With Pembrolizumab With/Without Chemotherapy for Treating Stage IV Lung Cancer

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 17, 2024 (before its estimated February 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Suspended to Recruiting Site details revisedv9 Show 1 more changeShow less
    • Site details revised
  2. Trial status: Recruiting to Suspended Sponsor's reason: Pending a protocol amendment Interventions: Biospecimen Collection (Procedure), Carboplatin (Drug), Computed Tomography (Procedure), Fludeoxyglucose F-18 (Other), Ipilimumab… to Atezolizumab (Biological), Biospecimen Collection (Procedure), Carboplatin (Drug), Cemiplimab (Biological), Computed Tomography… · Study description expanded, about 609 words · Site details revised · 1 morev8 Show 4 more changesShow less
    • Interventions: Biospecimen Collection (Procedure), Carboplatin (Drug), Computed Tomography (Procedure), Fludeoxyglucose F-18 (Other), Ipilimumab… to Atezolizumab (Biological), Biospecimen Collection (Procedure), Carboplatin (Drug), Cemiplimab (Biological), Computed Tomography…
    • Study description expanded, about 609 words
    • Site details revised
    • Study arms: 4 to 11

    See this version in full on ClinicalTrials.gov ↗

  3. Eligibility criteria shortened, about 18 wordsv7 See this version in full on ClinicalTrials.gov ↗
  4. Trial status: Suspended to Recruiting Site details revisedv6 Show 1 more changeShow less
    • Site details revised
  5. Trial status: Recruiting to Suspended Sponsor's reason: Pending a protocol amendment Interventions: Biospecimen Collection (Procedure), Carboplatin (Drug), Computed Tomography (Procedure), Fludeoxyglucose F-18 (Other), Nab-paclitaxel… to Biospecimen Collection (Procedure), Carboplatin (Drug), Computed Tomography (Procedure), Fludeoxyglucose F-18 (Other), Ipilimumab… · Eligibility criteria shortened, about 99 words · Study description expanded, about 196 words · 2 morev5 Show 5 more changesShow less
    • Interventions: Biospecimen Collection (Procedure), Carboplatin (Drug), Computed Tomography (Procedure), Fludeoxyglucose F-18 (Other), Nab-paclitaxel… to Biospecimen Collection (Procedure), Carboplatin (Drug), Computed Tomography (Procedure), Fludeoxyglucose F-18 (Other), Ipilimumab…
    • Eligibility criteria shortened, about 99 words
    • Study description expanded, about 196 words
    • Site details revised
    • Study arms: 1 to 4

    See this version in full on ClinicalTrials.gov ↗

Show 3 earlier versionsHide 3 earlier versions
  1. Primary completion date: Oct 1, 2025 to Feb 1, 2026 Completion date: Oct 1, 2026 to Feb 1, 2027 · Start date changed from estimate of Mar 16, 2023 to May 9, 2023v4 Show 2 more changesShow less
    • Completion date: Oct 1, 2026 to Feb 1, 2027
    • Start date changed from estimate of Mar 16, 2023 to May 9, 2023
  2. Trial status: Not Yet Recruiting to Recruiting Start date: Jan 31, 2023 to Mar 16, 2023 · Site details revisedv3 Show 2 more changesShow less
    • Start date: Jan 31, 2023 to Mar 16, 2023
    • Site details revised
  3. Start date: Sep 1, 2022 to Jan 31, 2023 Eligibility criteria expanded, about 20 wordsv2 Show 1 more changeShow less
    • Eligibility criteria expanded, about 20 words

    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 I/II trial tests the safety and efficacy of split-course adaptive radiation therapy in combination with immunotherapy with or without chemotherapy for the treatment of patients with stage IV lung cancer or lung cancer that that has spread to nearby tissue or lymph nodes (locally advanced). Radiation therapy is a standard cancer treatment that uses high energy rays to kill cancer cells and shrink tumors. Split-course adaptive radiation therapy uses patient disease response to alter the intensity of the radiation therapy. Immunotherapy with monoclonal antibodies such as pembrolizumab, ipilimumab, cemiplimab, atezolizumab or nivolumab 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 like carboplatin, pemetrexed, and paclitaxel work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving split-course adaptive radiation therapy with standard treatments like immunotherapy and chemotherapy may be more effective at treating stage IV or locally advanced lung cancer than giving them alone.
Trial Details
NCT Number NCT05501665
Lead Sponsor Vanderbilt-Ingram Cancer Center
Collaborators: National Cancer Institute (NCI), Varian Medical Systems
Conditions Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8, Stage III Lung Cancer
Enrollment 25 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov