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

NCT04836429 | Terminated Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: I 767720
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pleural Disorder; Lung Non-Small Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Incidence of serious adverse events (SAE)

  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.

  28 days post study-related immunotherapy

Secondary Outcomes (4)

• Progression-free survival (PFS)

  assessed up to 1 year

• Overall survival (OS)

  assessed up to 1year

• Changes in the immune phenotype of peripheral blood CD8+ T cells

  Baseline up to 1year

• Changes in platelet-to-lymphocyte ratio

  Baseline up to 1 year

Study Arms (1)

Treatment (porfimer sodium, photodynamic therapy)

EXPERIMENTAL

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

Drug: Porfimer Sodium; Procedure: Video-Assisted Thoracic Surgery; Drug: Photodynamic Therapy; Device: Intraoperative PDT

Interventions

Photodynamic Therapy DRUG

Undergo photodynamic therapy

Also known as: PDT

Treatment (porfimer sodium, photodynamic therapy)

Intraoperative PDT DEVICE

Subjects will receive one course of light therapy at the time of surgery

Also known as: intra-operative photo dynamic therapy

Treatment (porfimer sodium, photodynamic therapy)

Video-Assisted Thoracic Surgery PROCEDURE

Undergo VATS

Also known as: VATS

Treatment (porfimer sodium, photodynamic therapy)

Porfimer Sodium DRUG

Given IV

Also known as: 87806-31-3, CL-184116, Dihematoporphyrin Ester, Photofrin II

Treatment (porfimer sodium, photodynamic therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed non-small cell lung cancer (NSCLC) with pleural disease and PDL1 expression \< 50% or histologically confirmed diagnosis of malignant pleural mesothelioma not candidates for macroscopic complete resection
• Adequate blood tests 14 days prior to intraoperative PDT and with values within the ranges specified below.
• Hemoglobin ≥ 9.0 g/L
• Absolute neutrophil count ≥ 1.5 x 10\^9/L
• Platelets ≥ 100 x 10\^9/L
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (except participants with Gilbert's Syndrome, who are eligible with bilirubin ≤ 2.5 ULN)
• Alanine transaminase ≤ 2.5 xupper limit of normal (ULN), unless liver metastases or invasion are present, in which case it must be ≤ 5 x ULN
• Aspartate aminotransferase ≤ 2.5 x ULN, unless liver metastases or invasion are present, in which case it must be ≤ 5 x ULN
• The patient is on standard of care immunotherapy or combination of chemotherapy and immunotherapy 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 treatment 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 and tissue healing.
• Age \>= 18 years old
• Life expectancy of at least 12 weeks.
• 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

You may not qualify if:

• 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 such as active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g. colitis or Crohn's disease\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\]). The following are exceptions to this criterion:
• Patients with vitiligo or alopecia
• Patients with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Pleural Diseases

Interventions

Dihematoporphyrin Ether; Trioxsalen; Thoracic Surgery, Video-Assisted; Photochemotherapy; 1-phenyl-3,3-dimethyltriazene

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Hematoporphyrin Derivative; Hematoporphyrins; Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Pigments, Biological; Biological Factors; Furocoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, 3-Ring; Thoracoscopy; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Video-Assisted Surgery; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures; Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Officials

• • Saikrishna Yendamuri, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 8, 2021
• Study Start: March 10, 2022
• Primary Completion: February 3, 2024
• Study Completion: January 3, 2025
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)