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Photodynamic Therapy + Immunotherapy for Non-Small Cell Lung Cancer

Phase 1
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
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
My lung cancer involves the pleura and has low PDL1 levels, or I have mesothelioma not suitable for complete surgical removal.
I can carry out all my usual activities without help.
I am 18 years old or older.


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

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

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
First Studied
Drug Approval Stage
How many patients have taken this drug
Photodynamic Therapy
Completed Phase 4
Porfimer Sodium
Completed Phase 2

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor
402 Previous Clinical Trials
30,842 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have signed up for this experiment?

"Affirmative, according to information hosted on clinicaltrials.gov this trial is currently recruiting participants. Initially posted on March 10th 2022 before being updated November 9th, the study seeks 16 individuals from a single site."

Answered by AI

Has Porfimer Sodium been sanctioned by the FDA?

"Our team at Power gave Porfimer Sodium a score of 1 on the safety scale, seeing that it is only in Phase 1 trials and there are limited data regarding its efficiency and security."

Answered by AI

Are there any openings for volunteers to join this research endeavor?

"Affirmative. The online clinicaltrials.gov repository indicates that this research initiative, which was first published on March 10th 2022, is actively seeking participants. Approximately 16 individuals must be enrolled at 1 medical site."

Answered by AI

Are there any other clinical experiments utilizing Porfimer Sodium?

"At present, Porfimer Sodium is in the midst of 5 active trials with none reaching Phase 3. Most studies for this drug are taking place in Buffalo, NY; however, there are 6 total study sites that have opened their doors to clinical trial participants."

Answered by AI
~4 spots leftby Mar 2025