Roswell Park Cancer Institute
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.
PRIMARY OBJECTIVE: I. To assess objective response rate of tumors and lymph nodes following photoimmunotherapy and anti-PD1. SECONDARY OBJECTIVES: I. Overall survival following photoimmunotherapy and anti-PD1. II. To assess median progression free survival following photoimmunotherapy and anti-PD1. III. To assess the relationship between light irradiance and fluence dose volume histograms and objective tumors response following photoimmunotherapy and anti-PD1. IV. To evaluate the safety of cetuximab sarotalocan sodium (ASP-1929) photoimmunotherapy in combination with immune checkpoint inh…
Inclusion Criteria: * Age ≥ 18 years of age * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Subjects with histologically or cytologically confirmed stage IIIB-IV NSCLC * Subjects lacking actionable genetic mutations must have been previously treated with (a) anti-PD-1/PD-L1 therapy; and (b) platinum-based chemotherapy, either as combination or sequentially for metastatic disease and have progressed on or after therapy. Individuals who cannot tolerate or have previously refused platinum-based chemotherapy or who are unable to receive it are eligible to enroll ba…
Undergo blood sample collection
Given IV
Given IV
Undergo CT or PET/CT
Ancillary studies
Undergo EBUS
Undergo MRI
Undergo EB-PIT
Undergo I-PIT
Undergo PET/CT
Undergo robotic bronchoscopy
Undergo VATS