Robotic-assisted photodynamic therapy for peripheral lung cancer

A Multicenter Open-label Phase 1/1b Study to Evaluate Safety, Feasibility and Early Treatment Effect of Padeliporfin VTP Using Robotic Assisted Bronchoscopy and Cone Beam CT Guidance in Patients With Peripheral Lung Cancer

This study is testing a new robotic-assisted treatment for high-risk lung cancer to see if it is safe and effective before surgery.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Impact Biotech Ltd (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT05918783 on ClinicalTrials.gov

What this trial studies

This phase 1/1b clinical trial evaluates the safety and feasibility of Padeliporfin vascular targeted photodynamic therapy (VTP) using robotic-assisted bronchoscopy in patients with high-risk peripheral primary lung cancer. The study aims to titrate light doses and assess therapeutic ablation effects, with surgery planned 5 to 21 days after the VTP procedure. Patients will undergo a multi-disciplinary evaluation to confirm eligibility and will have their tumors assessed for size and location prior to treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with primary lung lesions at high risk for malignancy, specifically stage 1A1/1A2 tumors.

Not a fit: Patients with lung lesions that are contiguous with the pleura or those with larger tumors may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a minimally invasive treatment option that enhances surgical outcomes for patients with early-stage lung cancer.

How similar studies have performed: While this approach is innovative, similar studies using photodynamic therapy have shown promise, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

1. Age ≥18
2. 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.
3. All patients will be approved by a multi-disciplinary team (thoracic surgery, interventional pulmonology, medical oncology and radiation oncology) as appropriate for bronchoscopic VTP prior to surgical resection.
4. Tumor size targeted for VTP treatment ≤ 2 cm (Part A) and \<3cm (Part B), based on CT scan, including solid or semi-solid tumors.
5. EBUS mediastinal staging performed intraoperative prior to VTP treatment with rapid on-site evaluation negative for nodal involvement of malignancy.
6. 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).
7. Lung lesion is not contiguous with and ≥ 1 cm from the pleura/fissures.
8. Patient is eligible to undergo bronchoscopy under general anesthesia.
9. Tumor is accessible for Padeliporfin VTP treatment via robotic bronchoscopy
10. ECOG performance score 0-2
11. Estimated life expectancy of ≥3 months
12. Adequate organ system function
13. Negative serum pregnancy test

Exclusion Criteria:

1. 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, pulmonary artery, esophagus, vertebra's body or spinal canal).
2. Patient has a lung lesion located less than 1 cm from the pleura or fissure
3. Patient has a lung cancer lesion \>2cm in diameter, for the expansion cohort lesion \>2-3 cm
4. Patient has cytologic or histologic evidence of nodal disease
5. Tumor invades major vessels
6. Prior exposure to VTP or PDT treatments
7. Pregnant or breastfeeding women
8. Receiving any other investigational treatment
9. Co-morbidities:

   1. Baseline hypoxia with O2 saturation \<92% on 2L NC or more of oxygen
   2. New York Heart Association (NYHA) stage III/IV heart failure
   3. Unstable coronary artery disease or MI within the last 6 months
   4. Uncontrollable clinically serious arrhythmia
   5. Decompensated/clinically worsening interstitial lung disease or obstructive lung disease.
   6. Unstable cerebrovascular or peripheral vascular disease
   7. Inability to stop anticoagulation or anti-platelet therapy peri-procedure
   8. Evidence of clinically active infection requiring systemic (any route) antibiotic therapy. All prior infections must have resolved following optimal therapy.
   9. Patient has any acute or chronic condition assessed as clinically significant by Investigator which may preclude bronchoscopy procedure
   10. History of medical or psychiatric disease which, in the view of the investigator, would preclude safe treatment or acceptable study compliance
   11. Known severe pulmonary hypertension (mean pulmonary arterial pressure ≥ 50 mmHg)
10. Patient has a cancer diagnosis with active disease requiring further cancer therapy.
11. Patient has had major surgery within the last 4 weeks.
12. Patient has porphyria or hypersensitivity to padeliporfin or porphyrin-like compounds or to any of its excipients.

Where this trial is running

Baltimore, Maryland

• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Lonny Yarmus, MD — Johns Hopkins University
• Study coordinator: Eyal Morag, MD

Conditions Peripheral Lung Tumor