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Photodynamic Therapy + Immunotherapy for Non-Small Cell Lung Cancer
Phase 1
Recruiting
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
Timeline
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 belowSelect...
My lung cancer involves the pleura and has low PDL1 levels, or I have mesothelioma not suitable for complete surgical removal.
Select...
I can carry out all my usual activities without help.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 2 years
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 moreTrial 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
402 Previous Clinical Trials
30,842 Total Patients Enrolled
• Saikrishna Yendamuri, MDPrincipal InvestigatorRoswell Park Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on immunotherapy or chemo and immunotherapy without my cancer getting worse.My lung cancer involves the pleura and has low PDL1 levels, or I have mesothelioma not suitable for complete surgical removal.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I am currently pregnant or breastfeeding.I haven't had chemotherapy or radiation in the last 4-6 weeks and have recovered from any side effects.I can carry out all my usual activities without help.Your platelet count is less than 100,000.I do not have autoimmune or inflammatory disorders that would make me unsuitable for porfimer sodium.I have an autoimmune disorder and take steroids or immunosuppressants.I have brain metastases that are either untreated or not stable despite treatment.You are expected to live for at least 12 more weeks.You have a condition called porphyria, or you are allergic to substances similar to porphyrins.I am 18 years old or older.Your recent blood tests need to show certain values within a specific range.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (porfimer sodium, photodynamic therapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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