New combo therapy offers hope for cancer patients who Can't breathe
NCT ID NCT06306638
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a two-step treatment for people with advanced cancer that blocks their airways. First, they get low-dose radiation to shrink the tumor. Then, they receive a light-activated drug through an IV, followed by a laser to destroy remaining tumor cells. The goal is to improve breathing and survival with fewer side effects than high-dose radiation alone. About 42 adults with inoperable tumors will participate.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 42 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Oct 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age \>= 18 years of age * Eligibility checklist before registration requires review of case by the interventional pulmonologist/s and radiation oncologist/s to approve anatomic feasibility of an airway intervention and palliative radiotherapy * Patients with pathologic diagnosis of inoperable solid malignancy involving extrabronchial tumor growth that causes airway obstruction and not amenable to curative radiotherapy. All patients will have tumors requiring bronchoscopic intervention with endobronchial ultrasound (EBUS) at the time of I-PDT * Participants have at least one measurable lesion which is also the target lesion for Response Evaluation Criteria in Solid Tumors (RECIST) measurement * Patients amenable to receive standard of care palliative radiotherapy to the target tumor, as determined by the radiation oncologist/s * Amenable to high resolution chest CT (with or without contrast due to contraindication) with 0.625-1.25 mm slice thickness and slice interval 0.5-1 mm * Tumor is accessible and amenable to I-PDT, as determined by the interventional pulmonologist/s * 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) * International normalized ratio (INR) \< 1.5 and activated partial thromboplastin time (aPTT) \< 1.5 x ULN. PTT or aPTT per institutional standards for participating external sites * 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 and for 3 months after receiving the study drug. 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: * Pregnant or nursing female participants * Co-existing ophthalmic disease likely to require slit-lamp examination within the next 30 days following I-PDT treatment * Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive the I-PDT * CT imaging suggestive of target tumor invasion into a major blood vessel (typically proximal to segmental vessels) * Known hypersensitivity/allergy to porphyrin * Patients who are not cleared by the anesthesiologist to undergo an advanced bronchoscopy procedure under general anesthesia * Patients diagnosed with porphyria * Patients with known allergy to eggs * Patients unwilling or unable to follow protocol requirements
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Abramson Cancer Center
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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Roswell Park Cancer Institute
RECRUITINGBuffalo, New York, 14263, United States
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