Clinical trial · Interventional
Photodynamic Therapy During Surgery in Treating Patients With Non-small Cell Lung Cancer That Can Be Removed by Surgery
A Phase I Study of Surgery Plus Intraoperative Photodynamic Therapy (PDT) With Temoporfin in Patients With Resectable Primary Non-small Cell Lung Cancer (NSCLC) With Ipsilateral Thoracic Nodal (N1 or N2) or T3/T4 Disease
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase I trial studies the side effects and best dose of photodynamic therapy during surgery in treating patients with non-small cell lung cancer that can be removed by surgery. Photodynamic therapy uses a drug, such as temoporfin, that becomes active when it is exposed to a certain kind of light. When the drug is active, cancer cells are killed. This may be a better way to treat patients with non-small cell lung cancer.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Non-Small Cell Lung Carcinoma | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IIA Non-Small Cell Lung Carcinoma | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IIB Non-Small Cell Lung Carcinoma | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IIIA Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IIIB Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Pharmacological Study | Other | — | UNRESOLVED |
| Photodynamic Therapy | Drug | — | UNRESOLVED |
| Temoporfin | Drug | Temoporfin | ALIAS |
| Therapeutic Conventional Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (surgery and intraoperative PDT)
- description
- Patients receive temoporfin IV over no less than 6 minutes and then undergo standard surgical resection with intraoperative PDT.
- interventionNames
- Drug: Temoporfin
- Procedure: Therapeutic Conventional Surgery
- Drug: Photodynamic Therapy
- Other: Laboratory Biomarker Analysis
- Other: Pharmacological Study
Primary outcomes (1)
- measure
- Maximum tolerated dose of PDT with temoporfin, defined as the dose level in which more than 1 of 6 patients experience a dose limiting toxicity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4
- timeFrame
- 2 weeks
Secondary outcomes (4)
- measure
- Locoregional recurrence-free rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed non-small cell lung cancer (NSCLC) * Patients with resectable primary NSCLC who are undergoing surgery to resect T3 to T4 lesions OR any patients with clinical NI or N2 disease regardless of T-stage * Subjects must have an Eastern Cooperative Oncology Group (ECOG) scale of 0-2 * 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 or legal representative 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 * Must consent to participate in study I 03103: Roswell Park Cancer Institute (RPCI) Data Bank and Biorepository (DBBR) Exclusion Criteria: * Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier * Patients with known brain metastases should be excluded from this clinical trial * Patients with porphyria, or with known hypersensitivity to porphyrins or porphyrin-like compounds * White blood cell (WBC) \< 4,000 * Platelet count \< 100,000 * Total serum bilirubin \> 2 mg/dL * Serum creatinine \> 2 mg/dL * Alkaline phosphatase (hepatic) or serum glutamic oxaloacetic transaminase (SGOT) \> 3 times the upper normal limit * 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 study drug * Received an investigational agent within 30 days prior to enrollment
References
Publications (0)
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