Non-Small Cell Lung CancerPhase 1NCT04809103
Intratumoral Cisplatin for Resectable NSCLC
A Phase 1 study testing cis-diamminedichloroplatinum in people with Non-Small Cell Lung Cancer, run by University of Vermont at 1 site in United States.
Trial summary
PRIMARY OBJECTIVE: To identify the maximum tolerated dose (MTD) of intratumoral cisplatin, delivered during a single bronchoscopy with cone-beam CT confirmation, in a dose escalation protocol DESIGN: 3+3 dose escalation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- cis-diamminedichloroplatinum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2021to 1 Oct 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 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)
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Trial of Intratumoral Cisplatin for Early Stage, Resectable, Non-Small Cell Lung Cancer
PRIMARY OBJECTIVE:
To identify the maximum tolerated dose (MTD) of intratumoral cisplatin, delivered during a single bronchoscopy with cone-beam CT confirmation, in a dose escalation protocol
DESIGN: 3+3 dose escalation.
Read the detailed description
Non-small cell lung cancer (NSCLC) is the leading cause of cancer-related death in the United States. Even for early stage disease, the rate of recurrence following surgical resection is as high as 50%. Although neoadjuvant therapy, administered before surgery, for early stage lung cancer is associated with a survival benefit, it is rarely used due to the systemic toxicity of intravenous (IV) cytotoxic chemotherapy. IV immunotherapies are also being evaluated in combination with systemic therapies in the neoadjuvant setting. However, only a minority of patients respond to immunotherapy. One of the most common reasons for failure of immunotherapy is lack of presentation of tumor antigens to the immune system, a problem that may be potentially addressed with cytotoxic agents.
Over the last several years, case series have demonstrated the feasibility and safety of delivering cisplatin directly into lung tumors. Given the current knowledge of safety and tolerability of intratumoral cisplatin, coupled with the potential to achieve immune priming that may help address systemic micrometastases, the investigators postulate that intratumoral cisplatin will be well-tolerated, and potentially effective, neoadjuvant therapy for patients with early stage, resectable, non-small cell lung cancer.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- cis-diamminedichloroplatinum
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cis-diamminedichloroplatinumDrug
Also called cisplatin
Cisplatin delivered bronchoscopically at the time of diagnosis of NSCLC
| Study group | Role | What they receive |
|---|---|---|
| Intratumoral Cisplatin 20 mg | Experimental | Second dose level Receives: Drug: cis-diamminedichloroplatinum |
| Intratumoral Cisplatin 10 mg | Experimental | First dose level Receives: Drug: cis-diamminedichloroplatinum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Dose Limiting Toxicity
Adverse events as defined using the Common Terminology Criteria for Adverse Events
Measured: Within 2 weeks of delivery
Secondary outcomes (1)
Major Pathologic Response
Evaluation of the tissue response to the drug
Measured: Assessed on the surgical resection specimen, performed within 30 days of bronchoscopic delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start8 Mar 2021
- Primary completion1 Oct 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-Small Cell Lung CancerStudies 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
- Dose escalation
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Responsible party
- Principal investigator, C. Matthew Kinsey MD, MPH, University of Vermont
- Investigators
- C. Matthew Kinsey, MD, MPH, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809103
- Sponsor's protocol ID
- 00001101
- Status last verified
- Oct 2025
- First submitted
- 8 Mar 2021
- Last updated
- 6 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Trial of Intratumoral Cisplatin for Early Stage, Resectable, Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04809103
- Acronym / sponsor ID
- 00001101
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 22 Mar 2021 (actual)
- Results
- Posted 6 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PRIMARY OBJECTIVE:
To identify the maximum tolerated dose (MTD) of intratumoral cisplatin, delivered during a single bronchoscopy with cone-beam CT confirmation, in a dose escalation protocol
DESIGN: 3+3 dose escalation.
Detailed description
Non-small cell lung cancer (NSCLC) is the leading cause of cancer-related death in the United States. Even for early stage disease, the rate of recurrence following surgical resection is as high as 50%. Although neoadjuvant therapy, administered before surgery, for early stage lung cancer is associated with a survival benefit, it is rarely used due to the systemic toxicity of intravenous (IV) cytotoxic chemotherapy. IV immunotherapies are also being evaluated in combination with systemic therapies in the neoadjuvant setting. However, only a minority of patients respond to immunotherapy. One of the most common reasons for failure of immunotherapy is lack of presentation of tumor antigens to the immune system, a problem that may be potentially addressed with cytotoxic agents.
Over the last several years, case series have demonstrated the feasibility and safety of delivering cisplatin directly into lung tumors. Given the current knowledge of safety and tolerability of intratumoral cisplatin, coupled with the potential to achieve immune priming that may help address systemic micrometastases, the investigators postulate that intratumoral cisplatin will be well-tolerated, and potentially effective, neoadjuvant therapy for patients with early stage, resectable, non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Dose escalation
| Arm | Type | Receives |
|---|---|---|
| Intratumoral Cisplatin 20 mg | Experimental | Drug: cis-diamminedichloroplatinumSecond dose level |
| Intratumoral Cisplatin 10 mg | Experimental | Drug: cis-diamminedichloroplatinumFirst dose level |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age ≥18 years.
- Eastern Cooperative Oncology Group performance status 0 or 1
- Patients must have adequate organ and marrow function as defined below:
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| cis-diamminedichloroplatinumAlso: cisplatinCisplatin delivered bronchoscopically at the time of diagnosis of NSCLC | Drug | Intratumoral Cisplatin 10 mg, Intratumoral Cisplatin 20 mg |
Primary outcome
Rate of Dose Limiting Toxicity
Time frame: Within 2 weeks of delivery
Adverse events as defined using the Common Terminology Criteria for Adverse Events
1 secondary outcome
Major Pathologic Response
Time frame: Assessed on the surgical resection specimen, performed within 30 days of bronchoscopic delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
C. Matthew Kinsey, MD, MPH principal investigator
University of Vermont
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 cis-diamminedichloroplatinum in people with Non-Small Cell Lung Cancer, run by University of Vermont 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 15 inclusion and 7 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: finished, as of the sponsor's last update on 6 Feb 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?
Yes. Results are posted in the registry (first posted 6 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Rate of Dose Limiting Toxicity (time frame: Within 2 weeks of delivery). 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 6 Feb 2026.