Intratumoral Cisplatin for Resectable NSCLC

NCT04809103 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: 00001101
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Rate of Dose Limiting Toxicity

  Adverse events as defined using the Common Terminology Criteria for Adverse Events

  Within 2 weeks of delivery

Secondary Outcomes (1)

• Major Pathologic Response

  Assessed on the surgical resection specimen, performed within 30 days of bronchoscopic delivery

Study Arms (2)

Intratumoral Cisplatin 20 mg

EXPERIMENTAL

Second dose level

Drug: cis-diamminedichloroplatinum

Intratumoral Cisplatin 10 mg

EXPERIMENTAL

First dose level

Drug: cis-diamminedichloroplatinum

Interventions

cis-diamminedichloroplatinum DRUG

Cisplatin delivered bronchoscopically at the time of diagnosis of NSCLC

Also known as: cisplatin

Intratumoral Cisplatin 10 mg; Intratumoral Cisplatin 20 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vermont: lead
• Johnson & Johnson: collaborator

Study Sites (1)

University of Vermont

Burlington, Vermont, 05405, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Results Point of Contact

• Title: C. Matthew Kinsey MD, MPH
• Organization: University of Vermont Medical Center

matt.kinsey@med.uvm.edu

802.656.3521

Study Officials

• C. Matthew Kinsey, MD, MPH

  University of Vermont

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Interventional Pulmonary

Model Details: Dose escalation

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 22, 2021
• Study Start: March 8, 2021
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: February 6, 2026
• Results First Posted: February 6, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)