Laser and Light-Sensitive drug shrink lung tumors in early trial
NCT ID NCT03735095
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tested a treatment called photodynamic therapy for people with advanced lung cancer that blocks airways. Patients received a light-sensitive drug followed by a laser to activate it inside the tumor. The goal was to see if the treatment is safe and can shrink tumors to ease symptoms. Nineteen adults with lung cancer took part.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Porfimer sodium (a light-sensitive drug)
- What this could lead to
- If successful, this approach could offer a new way to shrink airway-blocking tumors and improve breathing in people with advanced lung cancer.
- What could go wrong
- This is an early-phase trial with only 19 participants, so results may not apply to everyone. The treatment involves a drug that makes skin and eyes sensitive to light, and there is a risk of serious side effects.
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
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
19 people
The number who actually took part.
- Started
-
Feb 2020
- Finished
-
Jul 2024
- Lead sponsor
-
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
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
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: * \> 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.
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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.
Contacts and locations
Locations
-
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
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