| Eligibility |
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 old
- Life expectancy of at least 12 weeks.
- Subjects must have an Eastern Cooperative Oncology Group (ECOG) score of 0 - 1
- Subjects of child-bearing potential must agree to use adequate contraceptive methods
(e.g., hormonal or barrier method of birth control; abstinence) prior to study entry
and for 6 months after surgery. Should a woman become pregnant or suspect she is
pregnant while she or her partner is participating in this study, she should inform
her treating physician immediately
- The subject must understand the investigational nature of this study and sign an
Independent Ethics Committee/Institutional Review Board approved written informed
consent prior to receiving any study related procedure
- Platelet count < 100,000
Exclusion Criteria:
- Patients who received chemotherapy, chemoimmunotherapy or radiotherapy within <4 weeks
(6 weeks for nitrosoureas or mitomycin C) or those who have not recovered from
reversible adverse events prior to the scheduled surgery and intraoperative PDT.
- Patients with untreated or symptomatically unstable treated brain metastases should be
excluded from this clinical trial because of their poor prognosis and because they
often develop progressive neurologic dysfunction that would confound the evaluation of
neurologic and other adverse events. Patients with treated and stable brain metastases
(at least 28 days from last radiotherapy treatment) are eligible as long as steroids
are not required for symptom management
- Patients with porphyria, or with known hypersensitivity to porphyrins or
porphyrin-like compounds
- Absolute neutrophil count < 1500
- Left ventricular ejection fraction (LVEF) < lower level of normal (LLN)
- Total bilirubin > 2 mg/dL
- Creatinine clearance < 60 mL/min (Cockcroft Gault equation)
- Alkaline phosphatase (hepatic) > 3 times the upper normal limit (SGPT) > 3 times
the upper normal limit
- NOTE: Roswell Park clinical lab blood chemistry is performed on plasma unless
otherwise indicated
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements
- Pregnant or nursing female subjects
- Unwilling or unable to follow protocol requirements
- Any condition which in the Investigator's opinion deems the subject an unsuitable
candidate to receive porfimer sodium such as active or prior documented autoimmune or
inflammatory disorders (including inflammatory bowel disease [e.g. colitis or Crohn's
disease], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome
[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis,
hypophysitis, uveitis, etc.]). The following are exceptions to this criterion:
- Patients with vitiligo or alopecia
- Patients with hypothyroidism (e.g. following Hashimoto syndrome) stable on
hormone replacement
- Any chronic skin condition that does not require systemic therapy
- Patients without active disease in the last 5 years may be included
- Patients with celiac disease controlled by diet alone
- Patients with Hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
Exceptions include past or resolved Hepatitis B (defined as the presence of hepatitis
B core antibody [anti-HBc] and absence of HBsAg) and patients positive for hepatitis C
(HCV) antibody if polymerase chain reaction is negative for HCV RNA. HIV testing is
not required in absence of clinical suspicion of HIV
- Received an investigational agent within 30 days prior to enrollment
- History of, or active autoimmune disorder, requiring systemic steroids or
immunosuppressive agents. Exceptions allowed: patients with autoimmune dermatologic
conditions not requiring systemic steroids or immunosuppressive agents (e.g. vitiligo,
eczema, etc.), endocrine-related autoimmune conditions receiving appropriate hormonal
supplementation. Use of immunosuppressant drugs such as steroids, azathioprine,
tacrolimus, cyclosporine, etc. is not permitted within 4 weeks before recruitment
(exception allowed is use of steroids as hormone replacement therapy or as supportive
medication e.g. anti-emesis, contrast allergy, pre-medication, etc. or other
short-course therapy less than 2 weeks continuously within 4 weeks of study treatment)
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