Photoimmunotherapy With ASP-1929 and Cemiplimab for the Treatment of Refractory, Inoperable, and Metastatic Stage IIIB-IV Non-small Cell Lung Cancer

StatusWithdrawn
PhasePhase 2
Started

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Record History

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  1. Stopped Withdrawn before enrolling Sponsor's reason: Lack of funding Show 4 more changesShow less
    • Enrollment target: estimated 27 to confirmed 0
    • Eligibility criteria expanded, about 48 words
    • Secondary endpoints: details revised at 3 of 4 entries
    • Site contact updated
  2. Notable Start date: May 15, 2026 to Aug 15, 2026v8
  3. Notable Start date: Mar 15, 2026 to May 15, 2026v7
  4. Notable Start date: Jan 15, 2026 to Mar 15, 2026v6
  5. Notable Start date: Nov 1, 2025 to Jan 15, 2026v5
Show 3 earlier versionsHide 3 earlier versions
  1. Notable Start date: Sep 1, 2025 to Nov 1, 2025v4
  2. Minor Collaborators expanded, about 3 wordsv3
  3. Notable Start date: May 1, 2025 to Sep 1, 2025v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 II trial tests how well photoimmunotherapy (PIT) with ASP-1929 in combination with cemiplimab works in treating patients with stage IIIB-IV non-small cell lung cancer (NSCLC) that has not responded to previous treatment (refractory), that is not suitable for surgery (inoperable), or that has spread from where it first started to other places in the body (metastatic). PIT is a treatment that combines drugs that become active when exposed to light, such as ASP-1929, with immunotherapy to target and kill tumor cells. ASP-1929 combines cetuximab with a light-sensitive component, sarotalocan. Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called epidermal growth factor receptor (EGFR), which is found on some types of tumor cells. This may help keep tumor cells from growing. Sarotalocan is a fluorescent dye, infrared-activated fluorescent dye 700, that is light sensitive, and when activated by a special type of laser light, helps destroy or change tumor cells. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving PIT with ASP-1929 in combination with cemiplimab may kill more tumor cells in patients with refractory, inoperable, or metastatic stage IIIB-IV NSCLC.
Trial Details
NCT Number NCT06943664
Lead Sponsor Roswell Park Cancer Institute
Collaborators: Rakuten Medical, Inc.
Conditions
(from sponsor)
Lung Non-Small Cell Carcinoma, Metastatic Lung Non-Small Cell Carcinoma, Refractory Lung Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8
Related terms Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov