Peripheral Lung TumorPhase 1NCT05918783
Padeliporfin VTP Using Robotic Assisted Bronchoscopy in Peripheral Lung Cancer
A Phase 1 study testing Padeliporfin Vascular Targeted Photodynamic (VTP) therapy in people with Peripheral Lung Tumor, run by Impact Biotech Ltd at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Lung Tumor
- What is being tested?
- Padeliporfin Vascular Targeted Photodynamic (VTP) therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2024to 30 Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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, interventional 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.
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- 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
Who cannot join
- 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).
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21224
About this study
Official title: 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
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. Surgery will be performed at 5-21 days following the VTP procedure.
Study intervention: robotic assisted bronchoscopic Padeliporfin VTP lung ablation: vascular targeted photodynamic therapy using Padeliporfin photosensitizer.
Read the detailed description
A multicenter, open label, 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. Patients who are candidates for lung resection will be recruited as a diagnose and treat in the same anaesthesia, protocol; surgery will be performed at least 5 days and up to 21 days following the VTP procedure.
Study intervention will consist of robotic assisted bronchoscopic Padeliporfin VTP lung ablation: vascular targeted photodynamic therapy using Padeliporfin photosensitizer, an ablation mechanism with efficacy related to immune response post-ablation.
- Conditions
- Peripheral Lung Tumor
- Being tested
- Padeliporfin Vascular Targeted Photodynamic (VTP) therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Padeliporfin Vascular Targeted Photodynamic (VTP) therapyCombination product
Also called Padeliporfin VTP
Bronchoscopy will be performed with robotic assisted approach using standard practices using general anaesthesia and placement of the optic fiber intratumorally followed by IV administration of Padeliporfin for 10 min and laser light illumination.
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | will be a monotherapy light dose escalation with single dose of Padeliporfin at light laser doses of 150, 250 and 400 mW/cm for 20 minutes.
Part A will proceed with light dose escalation and will continue until the maximum tolerated light dose (MTD) and/or recommended phase 2 dose (RP2D) is defined. Receives: Combination Product: Padeliporfin Vascular Targeted Photodynamic (VTP) therapy |
| Part B | Experimental | will be a dose expansion part at MTD/RP2D dose level identified in Part A to further assess the safety, tolerability, and treatment effect of the MTD and/ or RP2D Receives: Combination Product: Padeliporfin Vascular Targeted Photodynamic (VTP) therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of robotic assisted bronchoscopic Padeliporfin VTP ablation
Incidence of treatment-related adverse events as assessed by CTCAE v5.0
Measured: Day 30
Feasibility of robotic assisted bronchoscopic Padeliporfin VTP treatment
Feasibility of robotic bronchoscopic light fiber delivery into the target lesion as confirmed by cone beam CT and complete VTP treatment
Measured: Day 1
Evaluate Maximum Tolerated light Dose and/or RP2D of Padeliporfin VTP ablation
Evaluate Maximum Tolerated light Dose and/or RP2D of robotic assisted bronchoscopic Padeliporfin VTP ablation (a vascular targeted photodynamic therapy with Padeliporfin of patients with peripheral stage 1A1/1A2) primary non-small cell lung cancers.
Measured: Day 14
Secondary outcomes (2)
Evaluation lung surgery feasibility
Number and severity of operative, postoperative adverse events Number and length of any delays to surgery or surgical cancellations Number of completed surgeries
Measured: Day 5-21
Evaluation of the ablation area
Acute radiographic changes on CT chest imaging obtained two days post Padeliporin VTP treatment
Measured: 2 days post Padeliprofin VTP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start28 May 2024
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Lung TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Part B recruitment will be opened upon completion of Part A light dose escalation.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Impact Biotech Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lonny Yarmus, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05918783
- Sponsor's protocol ID
- CLIN2201 LCM101
- Status last verified
- Oct 2026
- First submitted
- 25 Apr 2023
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05918783
- Acronym / sponsor ID
- CLIN2201 LCM101
- Conditions
- Peripheral Lung Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Impact Biotech LtdIndustry (pharma, biotech, devices)
- Study start
- 28 May 2024 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 26 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. Surgery will be performed at 5-21 days following the VTP procedure.
Study intervention: robotic assisted bronchoscopic Padeliporfin VTP lung ablation: vascular targeted photodynamic therapy using Padeliporfin photosensitizer.
Detailed description
A multicenter, open label, 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. Patients who are candidates for lung resection will be recruited as a diagnose and treat in the same anaesthesia, protocol; surgery will be performed at least 5 days and up to 21 days following the VTP procedure.
Study intervention will consist of robotic assisted bronchoscopic Padeliporfin VTP lung ablation: vascular targeted photodynamic therapy using Padeliporfin photosensitizer, an ablation mechanism with efficacy related to immune response post-ablation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Part B recruitment will be opened upon completion of Part A light dose escalation.
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Combination Product: Padeliporfin Vascular Targeted Photodynamic (VTP) therapywill be a monotherapy light dose escalation with single dose of Padeliporfin at light laser doses of 150, 250 and 400 mW/cm for 20 minutes. Part A will proceed with light dose escalation and will continue until the maximum tolerated light dose (MTD) and/or recommended phase 2 dose (RP2D) is defined. |
| Part B | Experimental | Combination Product: Padeliporfin Vascular Targeted Photodynamic (VTP) therapywill be a dose expansion part at MTD/RP2D dose level identified in Part A to further assess the safety, tolerability, and treatment effect of the MTD and/ or RP2D |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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, interventional 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.
Key exclusion criteria (23 listed)
- 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).
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Padeliporfin Vascular Targeted Photodynamic (VTP) therapyAlso: Padeliporfin VTPBronchoscopy will be performed with robotic assisted approach using standard practices using general anaesthesia and placement of the optic fiber intratumorally followed by IV administration of Padeliporfin for 10 min and laser light illumination. | Combination product | Part A, Part B |
Primary outcome
Safety of robotic assisted bronchoscopic Padeliporfin VTP ablation
Time frame: Day 30
Incidence of treatment-related adverse events as assessed by CTCAE v5.0
Feasibility of robotic assisted bronchoscopic Padeliporfin VTP treatment
Time frame: Day 1
Feasibility of robotic bronchoscopic light fiber delivery into the target lesion as confirmed by cone beam CT and complete VTP treatment
Evaluate Maximum Tolerated light Dose and/or RP2D of Padeliporfin VTP ablation
Time frame: Day 14
Evaluate Maximum Tolerated light Dose and/or RP2D of robotic assisted bronchoscopic Padeliporfin VTP ablation (a vascular targeted photodynamic therapy with Padeliporfin of patients with peripheral stage 1A1/1A2) primary non-small cell lung cancers.
2 secondary outcomes
Evaluation lung surgery feasibility
Time frame: Day 5-21
Evaluation of the ablation area
Time frame: 2 days post Padeliprofin VTP
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lonny Yarmus, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Padeliporfin Vascular Targeted Photodynamic (VTP) therapy in people with Peripheral Lung Tumor, run by Impact Biotech Ltd at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of robotic assisted bronchoscopic Padeliporfin VTP ablation (time frame: Day 30). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.