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Photodynamic Therapy + Immunotherapy for Non-Small Cell Lung Cancer

Phase 1
Waitlist Available
Led By • Saikrishna Yendamuri, MD
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Subjects must have an Eastern Cooperative Oncology Group (ECOG) score of 0 - 1
Must not have
Uncontrolled intercurrent illness including 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a new cancer treatment, which uses light to kill tumor cells, can help patients with lung cancer when used with immunotherapy.

Who is the study for?
This trial is for adults with non-small cell lung cancer and pleural disease who are on or eligible for standard immunotherapy, have a life expectancy of at least 12 weeks, and can consent to the study. They must not have had recent chemotherapy or unresolved side effects from previous treatments. Pregnant or nursing individuals and those with certain autoimmune disorders or unstable health conditions cannot participate.
What is being tested?
The trial tests intraoperative photodynamic therapy (PDT) using porfimer sodium alongside standard immunotherapy in patients. PDT aims to kill tumor cells by combining a light-sensitive drug with light exposure, potentially improving symptoms and quality of life.
What are the potential side effects?
Possible side effects include reactions related to the photosensitizing agent such as skin sensitivity to light, local tissue damage where treatment is applied, fatigue, nausea, and other potential immune-related adverse events due to the combination with immunotherapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung cancer involves the pleura and has low PDL1 levels, or I have mesothelioma not suitable for complete surgical removal.
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I can carry out all my usual activities without help.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
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I am currently pregnant or breastfeeding.
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I haven't had chemotherapy or radiation in the last 4-6 weeks and have recovered from any side effects.
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I have an autoimmune disorder and take steroids or immunosuppressants.
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I have brain metastases that are either untreated or not stable despite treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of serious adverse events (SAE)
Secondary study objectives
Changes in platelet-to-lymphocyte ratio
Changes in the immune phenotype of peripheral blood CD8+ T cells
Overall survival (OS)
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (porfimer sodium, photodynamic therapy)Experimental Treatment4 Interventions
Patients receive porfimer sodium IV over 3-5 minutes 24-48 hours prior to standard of care VATS, followed by photodynamic therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Photodynamic Therapy
2014
Completed Phase 4
~460
Porfimer Sodium
2017
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor
412 Previous Clinical Trials
32,730 Total Patients Enrolled
• Saikrishna Yendamuri, MDPrincipal InvestigatorRoswell Park Cancer Institute

Media Library

Photodynamic Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04836429 — Phase 1
Non-Small Cell Lung Cancer Research Study Groups: Treatment (porfimer sodium, photodynamic therapy)
Non-Small Cell Lung Cancer Clinical Trial 2023: Photodynamic Therapy Highlights & Side Effects. Trial Name: NCT04836429 — Phase 1
Photodynamic Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04836429 — Phase 1
~1 spots leftby Dec 2025
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