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

Part of paid clinical trials in Buffalo, New York.

Sponsor
Roswell Park Cancer Institute
Study ID
NCT06943664
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • 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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Cemiplimab — BIOLOGICAL
    Given IV
  • Cetuximab Sarotalocan Sodium — BIOLOGICAL
    Given IV
  • Computed Tomography — PROCEDURE
    Undergo CT or PET/CT
  • Electronic Health Record Review — OTHER
    Ancillary studies
  • Endobronchial Ultrasound Bronchoscopy — PROCEDURE
    Undergo EBUS
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Photoimmunotherapy — PROCEDURE
    Undergo EB-PIT
  • Photoimmunotherapy — PROCEDURE
    Undergo I-PIT
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT
  • Robotic Bronchoscopy — PROCEDURE
    Undergo robotic bronchoscopy
  • Video-Assisted Thoracic Surgery — PROCEDURE
    Undergo VATS

Study Details

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.

Key Dates

Start date
May 15, 2026
Status verified
Mar 2026
Primary completion
May 1, 2027
Completion
May 1, 2028

Study Design

Enrollment
27 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (photoimmunotherapy, ASP-1929, cemiplimab)
    Patients receive cemiplimab IV over 30 minutes on days 1, 22, and 43 of each cycle and ASP-1929 IV over 2 hours on day 8 of each cycle. Patients undergo EB-PIT via standard of care VATS once on day 9 of cycle 1 or I-PIT via EBUS or robotic bronchoscopy up to 3 times on day 9 of cycles 1, 2, and/or 3. Cycles repeat every 9 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, CT and/or PET/CT or MRI throughout the study.

Primary Outcome Measure

Overall response rate [ Time Frame: Up to 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Roswell Park Cancer InstituteBuffaloNew York14263
Prantesh Jain
[email protected]
716-845-8451
Prantesh Jain (PRINCIPAL_INVESTIGATOR)

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By research site
Roswell Park Cancer Institute· Buffalo, NY

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