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

5 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Porfimer Sodium in combination with photodynamic therapy for non-small cell lung cancer?

Photodynamic therapy using porfimer sodium has been effective in treating recurrent superficial bladder cancer and has shown potential in treating non-melanoma skin cancers. This suggests that porfimer sodium can be effective in targeting cancer cells when used in photodynamic therapy. ^{1 2 3 4 5}

Is photodynamic therapy with porfimer sodium generally safe for humans?

Photodynamic therapy with porfimer sodium is generally safe, but it can cause side effects like skin sensitivity to light, which may last for several weeks, and esophageal strictures (narrowing of the esophagus) in some cases. These side effects are not usually severe, but they are important to consider. ^{4 5 6 7 8}

How is the Photodynamic Therapy + Immunotherapy treatment for non-small cell lung cancer different from other treatments?

This treatment is unique because it combines photodynamic therapy (PDT), which uses light-activated compounds to kill cancer cells, with immunotherapy, which helps the immune system fight cancer. PDT is minimally invasive and targets cancer cells specifically, while immunotherapy boosts the body's natural defenses, offering a novel approach compared to traditional chemotherapy or radiation. ^{1 2 4 7 8}

Research Team

• Saikrishna Yendamuri, MD

Principal Investigator

Roswell Park Cancer Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Photodynamic therapy of human lung cancer xenografts in mice. [2019]

2. Ireland pubmed.ncbi.nlm.nih.gov

Nanoparticle targeted folate receptor 1-enhanced photodynamic therapy for lung cancer. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Photodynamic therapy using porfimer sodium as an alternative to cystectomy in patients with refractory transitional cell carcinoma in situ of the bladder. Bladder Photofrin Study Group. [2017]

4. England pubmed.ncbi.nlm.nih.gov

The pharmacokinetics and safety of porfimer after repeated administration 30-45 days apart to patients undergoing photodynamic therapy. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Photodynamic therapy in dermatology with porfimer sodium and benzoporphyrin derivative: an update. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Patient predictors of esophageal stricture development after photodynamic therapy. [2015]

7. Japan pubmed.ncbi.nlm.nih.gov

[Porfimer sodium (Photofrin-II)]. [2006]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Lack of effect of sex and disease state on the pharmacokinetics of porfimer sodium. [2018]