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

Summary

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.

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

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

BIOLOGICAL

Cemiplimab

Given IV

BIOLOGICAL

Cetuximab Sarotalocan Sodium

Given IV

PROCEDURE

Computed Tomography

Undergo CT or PET/CT

OTHER

Electronic Health Record Review

Ancillary studies

PROCEDURE

Endobronchial Ultrasound Bronchoscopy

Undergo EBUS

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Photoimmunotherapy

Undergo EB-PIT

PROCEDURE

Photoimmunotherapy

Undergo I-PIT

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

PROCEDURE

Robotic Bronchoscopy

Undergo robotic bronchoscopy

PROCEDURE

Video-Assisted Thoracic Surgery

Undergo VATS

Sponsors & Collaborators

• Rakuten Medical, Inc.

  collaborator INDUSTRY

• Roswell Park Cancer Institute

  lead OTHER

Principal Investigators

• Prantesh Jain · Roswell Park Cancer Institute

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-15

Primary Completion

2027-05-01

Completion

2028-05-01

FDA Drug

Yes

Countries

• United States

Study Locations