Photodynamic Therapy + Immunotherapy for Non-Small Cell Lung Cancer

Overseen By ASK Roswell

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Roswell Park Cancer Institute

Must be taking: Immunotherapy, Chemoimmunotherapy

Must not be taking: Steroids, Immunosuppressants

Disqualifiers: Brain metastases, Porphyria, Autoimmune disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to enhance the effects of immunotherapy for individuals with non-small cell lung cancer that has spread to the pleura (the lining around the lungs). It combines a drug called porfimer sodium with a special light treatment, known as photodynamic therapy, to target and kill cancer cells. The goal is to determine if this combination can improve overall treatment outcomes and quality of life. It suits those already on standard immunotherapy who have non-small cell lung cancer with pleural involvement and are not experiencing tumor progression. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

If you are currently on standard immunotherapy or a combination of chemotherapy and immunotherapy, you will need to pause these treatments for 4-6 weeks before the surgery and photodynamic therapy. They can be resumed 4-12 weeks after surgery, following the standard recovery timeline.

What prior data suggests that photodynamic therapy with porfimer sodium is safe for non-small cell lung cancer patients?

Research has shown that porfimer sodium, used in photodynamic therapy, treats non-small cell lung cancer (NSCLC). It is specifically approved to clear blockages and relieve symptoms in patients with this type of lung cancer. This approval indicates that the treatment has been tested and shown to be somewhat safe for these uses.

In studies with other patients, photodynamic therapy with porfimer sodium was generally well-tolerated. However, side effects can occur. Some patients experienced skin sensitivity to light and other mild side effects. Clear information on serious side effects is not yet available, but since this trial is in an early stage, the main goal is to assess safety and side effects. Unknowns may still exist about its full safety when used with immunotherapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about photodynamic therapy using porfimer sodium for non-small cell lung cancer because it offers a unique approach compared to standard treatments like chemotherapy, radiation, and surgery. This treatment involves injecting porfimer sodium, which is a light-sensitive drug, into the bloodstream. Once the drug accumulates in the cancer cells, it is activated by a specific light during photodynamic therapy, causing the cancer cells to die. This targeted method means potentially fewer side effects and more precision in attacking cancer cells, which is a significant advancement over traditional therapies.

What evidence suggests that photodynamic therapy is effective for non-small cell lung cancer?

Research has shown that photodynamic therapy with porfimer sodium yields promising results for non-small cell lung cancer. In some studies, patients experienced a complete response, with significant tumor shrinkage. This trial will explore the effects of porfimer sodium, used in combination with light to destroy cancer cells. It already clears airway blockages in lung cancer, improving breathing and reducing symptoms. Early findings suggest this treatment might enhance the effects of immunotherapy, aiding the immune system in fighting cancer more effectively. Overall, encouraging evidence indicates that porfimer sodium can effectively treat lung cancer. ^{3 4 5 6 7}

Who Is on the Research Team?

• Saikrishna Yendamuri, MD

Principal Investigator

Roswell Park Cancer Institute

Are You a Good Fit for This Trial?

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.

Inclusion 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 can carry out all my usual activities without help.

Exclusion Criteria

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive porfimer sodium IV followed by photodynamic therapy to enhance the response to immunotherapy

4 weeks

1 visit (in-person) for photodynamic therapy, multiple visits for immunotherapy

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 days

2 visits (in-person)

Long-term follow-up

Participants are monitored for progression-free survival and overall survival

up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Porfimer Sodium

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment (porfimer sodium, photodynamic therapy) Experimental Treatment 4 Interventions

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

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5015713/

Photodynamic Therapy of Non–Small Cell Lung Cancer ... Moghissi and colleagues reported complete response in 100% of their patients treated with porfimer sodium PDT (50). Corti and colleagues, in 40 patients, used ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT00754910

Photodynamic Therapy Using Porfimer Sodium in Treating ... PURPOSE: This clinical trial is studying how well photodynamic therapy using porfimer sodium works in treating patients with non-small cell lung cancer and ...

3. photofrin.com photofrin.com/healthcare-professional-home/

PDT with PHOTOFRIN® (porfimer sodium) for Injection PHOTOFRIN is indicated for the reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial NSCLC.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022480421000330

Porfimer Sodium Versus PS785 for Photodynamic Therapy ... Porfimer sodium and PS785 produced statistically similar delays of tumor regrowth after PDT when small tumors were treated at 24 and 48 h. At 72 h, PS785 ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT00754910?term=AREA%5BBasicSearch%5D(AREA%5BConditionSearch%5D(%22Lung%20Non-Small%20Cell%20Carcinoma%22)%20AND%20AREA%5BInterventionSearch%5D(%22Ether%22))&rank=3

Photodynamic Therapy Using Porfimer Sodium in Treating ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

6. photofrin.com photofrin.com/endobronchial-non-small-cell-lung-cancer-nsclc/

Obstructing Endobronchial Non-Small-Cell Lung Cancer ... PHOTOFRIN® is indicated for the reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial NSCLC.

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2003/020451s012_Photofrin_PRNTLBL.pdf

PHOTOFRIN® (porfimer sodium) for Injection Reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial nonsmall cell lung cancer (NSCLC).