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.
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 based on progression after anti-PD-1/PD-L1 therapy alone
Has received an investigational agent within 30 days prior to initial treatment or less than 4 half-lives of a previous drug
Had a major surgery, (e.g., requiring general anesthesia) within 4 weeks before the first dose of study treatment or, will not have fully recovered from surgery prior to the first dose
Patients who received chemotherapy or chemoimmunotherapy within 21 days or those who have not recovered from reversible adverse events prior to the scheduled surgery and interstitial or intraoperative PIT
The participants received high dose or curative radiotherapy to the target tumor/s within 30 days prior to the planned I-PIT or EB-PIT
Single group
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Cemiplimab
Biological/VaccineGiven IV
Cetuximab Sarotalocan Sodium
Biological/VaccineGiven IV
Computed Tomography
Procedure/SurgeryUndergo CT or PET/CT
Electronic Health Record Review
Other interventionAncillary studies
Endobronchial Ultrasound Bronchoscopy
Procedure/SurgeryUndergo EBUS
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Photoimmunotherapy
Procedure/SurgeryUndergo EB-PIT
Photoimmunotherapy
Procedure/SurgeryUndergo I-PIT
Positron Emission Tomography
Procedure/SurgeryUndergo PET/CT
Robotic Bronchoscopy
Procedure/SurgeryUndergo robotic bronchoscopy
Video-Assisted Thoracic Surgery
Procedure/SurgeryUndergo VATS
Overall response rate
Will be defined as the proportion of patients who have a partial or complete response to therapy and will be assessed according to immune-modified Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1.
Overall survival
Will be defined as the time the patient is alive without tumor progression after treatment according to RECIST v 1.1. Will be estimated using the Kaplan-Meier estimator.
Median progression free survival (PFS)
Will be defined as the time the patient is alive without tumor progression after treatment according to RECIST v 1.1. Will be estimated using the Kaplan-Meier estimator. Corresponding median PFS will be estimated along with the respective 95% confidence interval.
Relationship between the light irradiance and fluence in the photoimmunotherapy treated tumor and the objective response of treated and untreated tumors
Will be determined by computing the dose volume histogram of the irradiance and fluence in the illuminated tumor/s and measuring the objective tumor response according to RECIST v 1.1. Will be analyzed using multivariate and univariate mixed effects logistic and standard logistic regression modeling.
Incidence of adverse events
Will be evaluated in accordance with Common Terminology Criteria for Adverse Events v 5.0.
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Roswell Park Cancer Institute
Lead sponsor
Rakuten Medical, Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
