Chemo shot straight to lung tumors tested in tiny trial
NCT ID NCT04809103
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tested whether injecting the chemotherapy drug cisplatin directly into lung tumors (during a bronchoscopy) is safe for people with early-stage, resectable non-small cell lung cancer. Only 6 participants were enrolled, and the main goal was to find the highest safe dose. The study is complete, but it is too small and early to know if this approach works better than standard treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cisplatin
- What this could lead to
- If it works, this could point toward a new way to deliver chemotherapy directly into lung tumors, potentially reducing side effects.
- What could go wrong
- This is a very early, small phase 1 trial with only 6 participants, focused on safety and dosing. It is not designed to prove effectiveness, and the approach may not work or may cause unexpected 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
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
6 people
The number who actually took part.
- Started
-
Mar 2021
- Finished
-
Oct 2025
- 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: * Age ≥18 years. * Eastern Cooperative Oncology Group performance status 0 or 1 * Patients must have adequate organ and marrow function as defined below: * Leukocytes ≥3,000/microliter * Platelets ≥100,000/microliter * Total bilirubin ≤ institutional upper limit of normal (ULN) * Aspartate aminotransferase /Alanine aminotransferase ≤3 × institutional upper limit of normal * Creatinine ≤ institutional ULN * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * Have known or suspected clinical stage I-IIb NSCLC after computed tomography (CT) and/or positron emission tomography at time of enrollment * Presence of a target lesion with a minimum volume of 1.0 cm3, (approximately1.2 cm in diameter) and ≤ 5.0 cm in diameter * Agreement from a cardiothoracic surgeon, following review of past medical history, medications, pulmonary function testing, and CT scan that patient is likely to be a surgical candidate and that, after considering known possible adverse events, delivery of intratumoral cisplatin is unlikely to adversely affect surgical feasibility * Rapid on-site cytopathologic examination (ROSE) performed during the procedure returns likely NSCLC (per the determination of a trained, attending, cytopathologist). No research procedures will be performed if ROSE is non-diagnostic * A CT scan of the chest (with or without contrast) within 1 month of the screening visit * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Use of an investigational agent within 30 days of the screening visit * IV chemotherapy within the 30 days of the screening visit * Pregnancy/lactation (pregnancy test to be performed by pre-op as part of standard of care for women of child-bearing age as defined by University of Vermont Medical Center Policy * History of prior radiation to the study lesion * History of allergic reaction to cisplatin or its derivatives * Patients with uncontrolled intercurrent illness * Physician determination that patient would not be appropriate for study
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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
-
University of Vermont
Burlington, Vermont, 05405, United States
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