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Phase I/II Trial in ES-SCLC to Enhance Response to Atezolizumab Plus Chemotherapy With Total Body Irradiation

Study acronym: TESSERACT
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Start date changed from estimate of Jul 31, 2024 to Apr 24, 2024 Eligibility criteria expanded, about 72 wordsv4 Show 1 more changeShow less
    • Eligibility criteria expanded, about 72 words

    See this version in full on ClinicalTrials.gov ↗

  2. Notable Primary completion date: Dec 31, 2026 to Jun 30, 2027 Start date: Jan 31, 2024 to Jul 31, 2024 · Completion date: Dec 31, 2027 to Jun 30, 2028v3 Show 2 more changesShow less
    • Start date: Jan 31, 2024 to Jul 31, 2024
    • Completion date: Dec 31, 2027 to Jun 30, 2028
  3. Notable Trial status: Not Yet Recruiting to Recruiting Start date: Dec 31, 2023 to Jan 31, 2024 · Site details revisedv2 Show 2 more changesShow less
    • Start date: Dec 31, 2023 to Jan 31, 2024
    • Site details revised
  4. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 studies the side effects, safety, and effectiveness of low dose radiation to the entire body (total body irradiation \[TBI\]) and higher dose radiation to known areas of cancer (hypofractionated radiation therapy \[H-RT\]) combined with atezolizumab and chemotherapy (carboplatin \& etoposide) in treating patients with small cell lung cancer that has spread to disease sites outside of the lung (extensive stage). Extensive stage disease has historically been treated with chemotherapy alone with consideration of chest (thoracic) radiation therapy for those with response to chemotherapy, as well as consideration of preventative radiation therapy to the head (prophylactic cranial irradiation). Emerging evidence supports the synergistic interactions between immunotherapy and radiation therapy. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. Combining TBI and H-RT with atezolizumab and chemotherapy may improve response to treatment.
Trial Details
NCT Number NCT06110572
Lead Sponsor Vanderbilt-Ingram Cancer Center
Collaborators: Genentech, Inc.
Conditions Extensive Stage Lung Small Cell Carcinoma, Stage IV Lung Cancer
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov