Photoimmunotherapy With ASP-1929 and Cemiplimab for the Treatment of Refractory, Inoperable, and Metastatic Stage IIIB-IV Non-small Cell Lung Cancer
Phase II Trial: Photoimmunotherapy and Anti-PD1 in Patients With Refractory Inoperable and Metastatic Non-Small Cell Lung Cancer
2 other identifiers
interventional
27
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2025
CompletedFirst Posted
Study publicly available on registry
April 24, 2025
CompletedStudy Start
First participant enrolled
May 15, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
Study Completion
Last participant's last visit for all outcomes
May 1, 2028
March 24, 2026
March 1, 2026
12 months
April 17, 2025
March 23, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Up to 2 years
Secondary Outcomes (4)
Overall survival
From the treatment to time of death from any reason, assessed up to 2 years
Median progression free survival (PFS)
Up to 2 years
Relationship between the light irradiance and fluence in the photoimmunotherapy treated tumor and the objective response of treated and untreated tumors
Up to 2 years
Incidence of adverse events
From the first day of the administration of the ASP-1929 up to 30 days after last treatment of ASP-1929 with cemiplimab
Study Arms (1)
Treatment (photoimmunotherapy, ASP-1929, cemiplimab)
EXPERIMENTALPatients 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.
Interventions
Undergo blood sample collection
Given IV
Given IV
Undergo CT or PET/CT
Ancillary studies
Undergo EBUS
Undergo MRI
Undergo EB-PIT
Undergo PET/CT
Undergo robotic bronchoscopy
Undergo VATS
Eligibility Criteria
You may qualify if:
- 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
- NSCLC with known actionable genomic alteration (e.g., EGFR, ALK, ROS1, BRAF) must have received all approved targeted therapies and have progressed (data capture not necessary for ALK, ROS1, BRAF)
- Subjects have at least two lesions of measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- At least one site of disease accessible to photoimmunotherapy. Thus, the therapeutic 690-nm laser light can be administered via insertion of optical fiber/s in the target tumor for interstitial photoimmunotherapy (I-PIT), or target tumors can be illuminated with external beam photoimmunotherapy (EB-PIT)
- Absolute neutrophil count: ≥ 1,000/µL
- Platelets: ≥ 100,000/µL
- Total bilirubin: ≤ institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \[SGPT\]): ≤ 3 x institutional ULN
- Creatinine clearance (CrCl) ≥ 50 mL/min (Cockcroft-Gault)
- Patient has not received a transfusion within 2 weeks prior to screening
- Female patients of childbearing potential must have a negative pregnancy test at screening and must be willing to use 2 methods of highly effective birth control while on study or be surgically sterile, or abstain from heterosexual sexual activity for the course of the study through 120 days after the last dose of anti-PD1 treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
- Male participants must agree to use a highly effective method of contraception starting with the first dose of study medication through 120 days after the last dose of anti-PD1 treatment
- +1 more criteria
You may not qualify if:
- 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
- Toxicity related to prior anticancer therapy that has not returned to grade ≤ 1 or baseline levels (except for alopecia, vitiligo, grade ≤ 2 peripheral neuropathy, and endocrinopathies that are stable on hormone replacement, which may be grade 2)
- History of immune-related adverse events (irAEs) from prior anticancer therapy leading to permanent treatment discontinuation
- History of solid organ or hematologic stem cell transplantation
- Prolonged corrected QT interval by Fredericia (QTcF) \> 470 msec or clinically significant cardiac arrhythmia or electrophysiologic disease (e.g., placement of implantable cardioverter defibrillator or atrial fibrillation with uncontrolled rate or abnormalities in conduction or morphology of electrocardiogram \[ECG\] \[e.g., complete left bundle branch block, third- or second-degree heart block, PR interval \> 250 msec\]). Note: Participants with cardiac pacemakers who are clinically stable are eligible
- Clinically significant cardiovascular disease, including any of the following within 6 months prior to signature of informed consent:
- Myocardial infarction, severe or unstable angina, or coronary artery bypass surgery
- Clinically significant arrhythmias (e.g., ventricular arrhythmias or atrial fibrillation with uncontrolled heart rate)
- Congestive heart failure (New York Heart Association \[NYHA\] class III/IV)
- Cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event
- Myocarditis
- Active bleeding diathesis or requirement for therapeutic anticoagulation that cannot be interrupted or altered for procedures
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Roswell Park Cancer Institutelead
- Rakuten Medical, Inc.collaborator
Study Sites (1)
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Prantesh Jain
Roswell Park Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2025
First Posted
April 24, 2025
Study Start (Estimated)
May 15, 2026
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
May 1, 2028
Last Updated
March 24, 2026
Record last verified: 2026-03