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New treatment option for Peripheral Lung Tumor
Official title Padeliporfin VTP Using Robotic Assisted Bronchoscopy in Peripheral Lung Cancer
ClinicalTrials.gov ID: NCT05918783
What this study is testing
What is Padeliporfin Vascular Targeted Photodynamic (VTP) therapy?
Padeliporfin Vascular Targeted Photodynamic (VTP) therapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for peripheral lung tumor.
Also referred to as Padeliporfin VTP.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Phase 1/1b, safety, feasibility, and light dose titration study followed by further study of therapeutic ablation effects. Patients with high risk of peripheral primary lung cancer, stage 1A1/1A2, for whom surgical treatment is planned, will be recruited.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18
- Patients with primary lung lesions who are at high risk for primary lung cancer. 2.1.Biopsy with intraoperative confirmation of malignancy using...
- All patients will be approved by a multi-disciplinary team (thoracic surgery, treatment pulmonology, medical oncology and radiation oncology) as...
- Tumor size targeted for VTP treatment ≤ 2 cm (Part A) and \<3cm (Part B), based on CT scan, including solid or semi-solid tumors.
- EBUS mediastinal staging performed intraoperative prior to VTP treatment with rapid on-site evaluation negative for nodal involvement of malignancy.
You likely can't join if
- Patient has a centrally located lung lesion, as defined by RTOG within 2 cm of the proximal bronchial tree, or within 2 cm of other major mediastinal...
- Patient has a lung lesion located less than 1 cm from the pleura or fissure
- Patient has a lung cancer lesion \>2cm in diameter, for the expansion cohort lesion \>2-3 cm
- Patient has cytologic or histologic evidence of nodal disease
- Tumor invades major vessels
- Prior exposure to VTP or PDT treatments
See the full eligibility criteria
- Age ≥18
- Patients with primary lung lesions who are at high risk for primary lung cancer. 2.1.Biopsy with intraoperative confirmation of malignancy using on-site cytology will be used as final inclusion prior to study treatment.
- All patients will be approved by a multi-disciplinary team (thoracic surgery, treatment pulmonology, medical oncology and radiation oncology) as appropriate for bronchoscopic VTP prior to surgical resection.
- Tumor size targeted for VTP treatment ≤ 2 cm (Part A) and \<3cm (Part B), based on CT scan, including solid or semi-solid tumors.
- EBUS mediastinal staging performed intraoperative prior to VTP treatment with rapid on-site evaluation negative for nodal involvement of malignancy.
- Tumor is ≥ 2cm from the central bronchial tree (distal 2 cm of the trachea, carina, and named major lobar bronchi up to their first bifurcation) (Timmerman, 2018).
- Lung lesion is not contiguous with and ≥ 1 cm from the pleura/fissures.
- Patient is eligible to undergo bronchoscopy under general anesthesia.
- Tumor is accessible for Padeliporfin VTP treatment via robotic bronchoscopy
- ECOG performance score 0-2
- Estimated life expectancy of ≥3 months
- Adequate organ system function
- Negative serum pregnancy test
- Patient has a centrally located lung lesion, as defined by RTOG within 2 cm of the proximal bronchial tree, or within 2 cm of other major mediastinal structure (aorta, heart, trachea, pericardium, superior vena cava...
- Patient has a lung lesion located less than 1 cm from the pleura or fissure
- Patient has a lung cancer lesion \>2cm in diameter, for the expansion cohort lesion \>2-3 cm
- Patient has cytologic or histologic evidence of nodal disease
- Tumor invades major vessels
- Prior exposure to VTP or PDT treatments
- Pregnant or breastfeeding women
- Receiving any other investigational treatment
- Co-morbidities:
- Baseline hypoxia with O2 saturation \<92% on 2L NC or more of oxygen
- New York Heart Association (NYHA) stage III/IV heart failure
- Unstable coronary artery disease or MI within the last 6 months
- Uncontrollable clinically serious arrhythmia
- Decompensated/clinically worsening interstitial lung disease or obstructive lung disease.
- Unstable cerebrovascular or peripheral vascular disease
- Inability to stop anticoagulation or anti-platelet therapy peri-procedure
- Evidence of clinically active infection requiring systemic (any route) antibiotic therapy. All prior infections must have resolved following optimal therapy.
- Patient has any acute or chronic condition assessed as clinically significant by Investigator which may preclude bronchoscopy procedure
- History of medical or psychiatric disease which, in the view of the investigator, would preclude safe treatment or acceptable study compliance
- Known severe pulmonary hypertension (mean pulmonary arterial pressure ≥ 50 mmHg)
- Patient has a cancer diagnosis with active disease requiring further cancer therapy.
- Patient has had major surgery within the last 4 weeks.
- Patient has porphyria or hypersensitivity to padeliporfin or porphyrin-like compounds or to any of its excipients.
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.