Photodynamic Therapy to Amplify the Response to Immunotherapy in Patients With Non-small Cell Lun… (NCT04836429) | Clinical Trial Compass
TerminatedPhase 1
Photodynamic Therapy to Amplify the Response to Immunotherapy in Patients With Non-small Cell Lung Cancer With Pleural Disease
Stopped: low accrual
United States5 participantsStarted 2022-03-10
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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
* Adequate blood tests 14 days prior to intraoperative PDT and with values within the ranges specified below.
* Hemoglobin ≥ 9.0 g/L
* Absolute neutrophil count ≥ 1.5 x 10\^9/L
* Platelets ≥ 100 x 10\^9/L
* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (except participants with Gilbert's Syndrome, who are eligible with bilirubin ≤ 2.5 ULN)
* Alanine transaminase ≤ 2.5 xupper limit of normal (ULN), unless liver metastases or invasion are present, in which case it must be ≤ 5 x ULN
* Aspartate aminotransferase ≤ 2.5 x ULN, unless liver metastases or invasion are present, in which case it must be ≤ 5 x ULN
* The patient is on standard of care immunotherapy or combination of chemotherapy and immunotherapy with no evidence of progression or a candidate for chemoimmunotherapy as determined by the treating medical oncologist. Eligible patients that are currently on standard of care treatment will have the systemic therapy paused for 4-6 weeks prior to the surgery and intraoperative PDT and will resumed within 4-12 weeks after surgery following standard of care timeframe utilized for restarting systemic therapy after major surgical procedures to ensure adequate post-op recovery and tissue healing.
* Age \>= 18 years …
What they're measuring
1
Incidence of serious adverse events (SAE)
Timeframe: 28 days post study-related immunotherapy