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

Overview

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.

Full Title of Study: “Utilizing Photodynamic Therapy to Amplify the Response to Immunotherapy in Patients With Non-Small Cell Lung Cancer (NSCLC) With Pleural Disease – Phase I Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 15, 2023

Interventions

  • Drug: Porfimer Sodium
    • Given IV
  • Procedure: Video-Assisted Thoracic Surgery
    • Undergo VATS
  • Drug: Photodynamic Therapy
    • Undergo photodynamic therapy
  • Device: Intraoperative PDT
    • Subjects will receive one course of light therapy at the time of surgery

Arms, Groups and Cohorts

  • Experimental: Treatment (porfimer sodium, photodynamic therapy)
    • Patients receive porfimer sodium IV over 3-5 minutes 24-48 hours prior to standard of care VATS, followed by photodynamic therapy

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of serious adverse events (SAE)
    • Time Frame: 28 days post study-related immunotherapy
    • Will be determined by recording the occurrence of SAE during the first 28 days post study-related immunotherapy. The SAE will be evaluated using the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Secondary Measures

  • Progression-free survival (PFS)
    • Time Frame: assessed up to 2 years
    • Will utilize Kaplan-Meier curves to descriptively examine dose level differences and generate summary statistics.
  • Overall survival (OS)
    • Time Frame: assessed up to 2 years
    • Will utilize Kaplan-Meier curves to descriptively examine dose level differences and generate summary statistics.
  • Changes in the immune phenotype of peripheral blood CD8+ T cells
    • Time Frame: Baseline up to 2 years
    • Will be analyzed using a repeated measures analysis-of-variance (ANOVA) model with a factor for dose level time and a dose level by time interaction.
  • Changes in platelet-to-lymphocyte ratio
    • Time Frame: Baseline up to 2 years
    • Will be analyzed using a repeated measures ANOVA model with a factor for dose level, time and a dose level by time interaction.

Participating in This Clinical Trial

Inclusion Criteria

  • Histologically confirmed non-small cell lung cancer (NSCLC) with pleural disease and PDL1 expression < 50% – The patient is on chemoimmunotherapy with no evidence of progression or a candidate for chemoimmunotherapy as determined by the treating medical oncologist. Eligible patients that are currently on standard of care chemoimmunotherapy will have the systemic therapy paused for 4-6 weeks prior to the surgery and intraoperative PDT and will resumed within 4-12 weeks after surgery following standard of care timeframe utilized for restarting systemic therapy after major surgical procedures to ensure adequate post-op recovery, tissue healing. – 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 received chemotherapy, chemoimmunotherapy or radiotherapy within <4 weeks (6 weeks for nitrosoureas or mitomycin C) or those who have not recovered from reversible adverse events prior to the scheduled surgery and intraoperative PDT. – 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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Roswell Park Cancer Institute
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • • Saikrishna Yendamuri, MD, Principal Investigator, Roswell Park Cancer Institute
  • Overall Contact(s)
    • ASK Roswell, 1-800-767-9355, askroswell@roswellpark.org

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