Photodynamic Therapy to Amplify the Response to Immunotherapy in Patients With Non-small Cell Lung Cancer With Pleural Disease

• Status: Recruiting
• Trial end date: 2023-12-15
• Target enrollment: 0
• Participant gender: All

Summary

This phase I trial evaluates the side effects of intraoperative photodynamic therapy with porfimer sodium in enhancing the response to immunotherapy with an immune checkpoint inhibitor drug in patients with non-small cell lung cancer with pleural disease. Photodynamic therapy is a technique that that works by combining a photosensitizing agent (porfimer sodium in this trial) and an intense light source to kill tumor cells. Photodynamic therapy may decrease the patients' symptoms and improve their quality of life.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Roswell Park Cancer Institute
• Treatments: Dihematoporphyrin Ether; Trioxsalen

Criteria

Inclusion Criteria:

• Histologically confirmed non-small cell lung cancer (NSCLC) with pleural disease and PDL1 expression < 50%

• The patient should be considered a candidate for chemoimmunotherapy by the treating medical oncologist

• Age >= 18 years of age

• Subjects must have an Eastern Cooperative Oncology Group (ECOG) score of 0 - 1

• Subjects of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for 6 months after surgery. 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

• The subject must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent prior to receiving any study related procedure

• Platelet count < 100,000

Exclusion Criteria:

• Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier

• Patients with untreated or symptomatically unstable treated brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Patients with treated and stable brain metastases (at least 28 days from last radiotherapy treatment) are eligible as long as steroids are not required for symptom management

• Patients with porphyria, or with known hypersensitivity to porphyrins or porphyrin-like compounds

• Absolute neutrophil count < 1500

• Left ventricular ejection fraction (LVEF) < lower level of normal (LLN)

• Total bilirubin > 2 mg/dL

• Creatinine clearance < 60 mL/min (Cockcroft Gault equation)

• Alkaline phosphatase (hepatic) > 3 times the upper normal limit (SGPT) > 3 times the upper normal limit

• NOTE: Roswell Park clinical lab blood chemistry is performed on plasma unless otherwise indicated

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

• Pregnant or nursing female subjects

• Unwilling or unable to follow protocol requirements

• Any condition which in the Investigator's opinion deems the subject an unsuitable candidate to receive porfimer sodium

• Received an investigational agent within 30 days prior to enrollment

• History of, or active autoimmune disorder, requiring systemic steroids or immunosuppressive agents. Exceptions allowed: patients with autoimmune dermatologic conditions not requiring systemic steroids or immunosuppressive agents (e.g. vitiligo, eczema, etc.), endocrine-related autoimmune conditions receiving appropriate hormonal supplementation. Use of immunosuppressant drugs such as steroids, azathioprine, tacrolimus, cyclosporine, etc. is not permitted within 4 weeks before recruitment (exception allowed is use of steroids as hormone replacement therapy or as supportive medication e.g. anti-emesis, contrast allergy, pre-medication, etc. or other short-course therapy less than 2 weeks continuously within 4 weeks of study treatment)