Clinical trial · Interventional
Endobronchial Ultrasound Guided Interstitial Photodynamic Therapy in Treating Patients With Locally Advanced Lung Cancer
Endobronchial Ultrasound Transbronchial Needle Guided Interstitial Photodynamic Therapy for Palliation of Locally Advanced Lung Cancer and Advanced Cancers Obstructing the Airway -Phase I/II
NCT03735095CI-TRIAL-00111549completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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/Il studies the side effects of endobronchial ultrasound guided interstitial photodynamic therapy work in treating patients with lung cancer that has spread to nearby tissues or lymph nodes. Photodynamic therapy consists of injecting a light sensitive drug called a photosensitizer, such as porfimer sodium, into the vein, waiting for it to accumulate in the tumor, and then activating it with a red laser light. Giving photodynamic therapy with Porfimer sodium may reduce the tumor size in patients with lung cancer.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Lung Carcinoma | Lung Carcinoma | CURATED_BROADER | 0.78 |
| Non-Small Cell Lung Carcinoma | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Small Cell Lung Carcinoma | Lung Small Cell Carcinoma | ALIAS | 0.90 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Stage IIIA Lung Cancer AJCC v8 | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Lung Cancer AJCC v8 | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIC Lung Cancer AJCC v8 | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Porfimer Sodium | Drug | Porfimer | ALIAS |
| Ultrasound-Guided Transbronchial Needle-Delivered Interstitial Photodynamic Therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (porfimer sodium, EBUS, and photodynamic therapy)
- description
- Treatment (porfimer sodium, EBUS, and photodynamic therapy) Patients receive 2 mg/kg porfimer sodium IV over 3-5 minutes 48 +/- 4 hours prior to the delivery of I-PDT. Patients then undergo EBUS-TBN guided I-PDT over few hours.
- interventionNames
- Drug: Porfimer Sodium
- Procedure: Ultrasound-Guided Transbronchial Needle-Delivered Interstitial Photodynamic Therapy
Primary outcomes (2)
- measure
- Number of Participants With Adverse Events That Are >= Grade 4 According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.0
- timeFrame
- Up to 4 weeks
- description
- Number of Participants with Adverse Events That Are \>= Grade 4 According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.0
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * \> 18 year olds * Eligibility checklist before registration requires review of case by study surgeon or interventional pulmonologists to approve anatomic feasibility of an airway intervention * For patients in Cohort B only. Patients are amenable to receive a palliative radiotherapy of 8 Gy x1 48±4 h prior to the I-PDT, as determined by the radiation oncologist * Patients with an established pathologic diagnosis of small cell and/or non-small cell lung cancer or other malignancies causing airway obstruction \> 25% requiring bronchoscopic intervention. Or inoperable malignancies not candidates for curative radiotherapy within the airway. * Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 3 * Platelets \>= 100,000 cells/mm\^3 (International System of Units \[SI\] units 100 x 10\^9/L). * Participants 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. 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. * Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure. Exclusion Criteria: * Participants who have had radiotherapy to the target tumor within 4 weeks prior to the scheduled I-PDT and/or PDT. * 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 participants. * Co-existing ophthalmic disease likely to require slit-lamp examination within 14 days following I-PDT and/or PDT treatment. * Known hypersensitivity/allergy to porphyrin. * Patients who are not cleared by the anesthesiologist to undergo an advanced bronchoscopy procedure under general anesthesia. * Patients with target tumor invading into the lumen of the esophagus, confirmed by esophago-gastro-duodenoscopy (EGD) with endoscopic ultrasound * Patients diagnosed with porphyria. * Unwilling or unable to follow protocol requirements. * Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive I-PDT or PDT.
References
Publications (0)
Data not yet available
No reference posted for this study.