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Clinical Trial NCT07495098 for Lung Cancer Metastatic, Lung Cancer (NSCLC) is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Phase 1B Trial of Intratumoral Cisplatin for Stage IV Lung Cancer Phase 1 12 Immunotherapy

Not yet recruiting
Clinical Trial NCT07495098 is designed to study Treatment for Lung Cancer Metastatic, Lung Cancer (NSCLC). This Phase 1 interventional study is not yet recruiting. Enrollment is planned to begin on 1 July 2026 until the study accrues 12 participants. Led by University of Vermont, this study is expected to complete by 30 June 2031. The latest data from ClinicalTrials.gov was last updated on 27 March 2026.
Brief Summary
The addition of intravenous (given through a vein) cisplatin to immunotherapy improves treatment outcomes for lung cancer, but unfortunately results in significantly more side effects since the rest of the body is exposed to significant amounts of the drug. Our clinical trial data indicate that injecting cisplatin directly into the tumor using a bronchoscope (a small flexible tube with a camera in it) has very few si...Show More
Detailed Description
Rationale:

Non-small cell lung cancer (NSCLC) is the leading cause of cancer-related death in the United States. The mainstay of therapy for lung cancer remains platinum-based chemotherapy. One of the most commonly used agents is cisplatin, due to the fact that it is highly toxic to cancer cells. Cisplatin binds with DNA, cross-linking strands and thereby inhibiting mitosis, which in turn leads to apoptosis and deat...

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Official Title

Phase 1B Trial of Intratumoral Cisplatin for Stage IV Lung Cancer

Conditions
Lung Cancer MetastaticLung Cancer (NSCLC)
Other Study IDs
  • 00000613B
NCT ID Number
NCT07495098
Start Date (Actual)
2026-07-01
Last Update Posted
2026-03-27
Completion Date (Estimated)
2031-06-30
Enrollment (Estimated)
12
Study Type
Interventional
PHASE
Phase 1
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
Non-Randomized
Interventional Model
Single Group
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalInitial Dose Cohort: 95% Tumor Coverage
Intratumoral cisplatin dosed to cover 95% of the tumor
cisplatin (cis-diamminedichloroplatinum(II) (CDDP))
The safety of intratumoral cisplatin will be evaluated by delivery region will be evaluated.
ExperimentalDe-escalation Dose Cohort: 90% Tumor Coverage
Intratumoral cisplatin dosed to cover 90% of the tumor
cisplatin (cis-diamminedichloroplatinum(II) (CDDP))
The safety of intratumoral cisplatin will be evaluated by delivery region will be evaluated.
ExperimentalEscalation Dose Cohort: 98% Tumor Coverage
Intratumoral cisplatin dosed to cover 98% of the tumor
cisplatin (cis-diamminedichloroplatinum(II) (CDDP))
The safety of intratumoral cisplatin will be evaluated by delivery region will be evaluated.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Safety, as defined by dose limiting toxicity (DLT)
Safety (dose limiting toxicity, DLT), as defined by CTCAE (Common Terminology Criteria for Adverse Events) v 6.0. CTCAE grade 3 or above will be considered a DLT.
For 4 weeks after initial delivery of intratumoral cisplatin
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Cisplatin retention
Post-injection platinum blood levels will allow calculation of retained cisplatin mass via an established pharmacokinetic model. Cisplatin retention will be evaluated by location of injection (low vs high % blood volume)
At each delivery
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All

  • Age 18 years or above

  • Eastern Cooperative Oncology Group (ECOG) performance score 0-2

  • Have known or suspected metastatic NSCLC at time of enrollment (including patients who progress on initial therapy or are found to have metastatic disease during therapy and are not excluded

  • Patient is able and willing to provide informed consent.

  • Rapid on-site cytopathologic examination (ROSE) performed during the procedure (if not previously diagnosed) and returns likely NSCLC. No injection will be performed if ROSE is non-diagnostic.

  • A CT scan of the chest (with or without contrast) within the prior 3 months.

  • The presence of an EBUS accessible target site determined by a treating investigator. These may be primary lung cancers or metastatic sites (including when a lymph node station has been replaced by metastatic tumor), that are accessible by EBUS.

  • MDC agreement of likely Stage IV NSCLC (confirmation from at minimum a Medical Oncologist and Radiation Oncologist on clinical stage).

  • Patients must have adequate organ and marrow function as defined below:

    • Leukocytes ≥3,000/mcL
    • Platelets ≥100,000/mcL
    • Total bilirubin ≤ institutional upper limit of normal (ULN)
    • AST(SGOT)/ALT(SGPT) ≤ institutional ULN
    • Creatinine ≤ institutional ULN

  • Use of an investigational agent in prior 30 days
  • 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 UVMMC Policy NPREP16)
  • Treatment with intravenous cytotoxic chemotherapy within the past 14 days
  • Allergy to cisplatin or its derivatives
  • Allergy to iodinated contrast
  • Patient not appropriate for the research study based on physician discretion
University of Vermont logoUniversity of Vermont52 active studies to explore
Study Responsible Party
C. Matthew Kinsey MD, MPH, Principal Investigator, Director, Interventional Pulmonary, University of Vermont
Study Central Contact
Contact: Kristi Chapman, 8026567953, [email protected]
No location data.