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Intratumoral Cisplatin for Resectable NSCLC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04809103
Recruitment Status : Recruiting
First Posted : March 22, 2021
Last Update Posted : March 22, 2021
Johnson & Johnson
Information provided by (Responsible Party):
C. Matthew Kinsey MD, MPH, University of Vermont

Tracking Information
First Submitted Date  ICMJE March 8, 2021
First Posted Date  ICMJE March 22, 2021
Last Update Posted Date March 22, 2021
Actual Study Start Date  ICMJE March 8, 2021
Estimated Primary Completion Date March 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2021)
Rate of dose limiting toxicity [ Time Frame: Within 2 weeks of delivery ]
Adverse events as defined using the Common Terminology Criteria for Adverse Events
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2021)
  • Major pathologic response [ Time Frame: Assessed on the surgical resection specimen, performed within 30 days of bronchoscopic delivery ]
    Evaluation of the tissue response to the drug
  • Blood biomarker panel [ Time Frame: Assessed from blood drawn on day of bronchoscopy and day of surgical resection ]
    Includes serum cytokine analysis, mass cytometry for inflammatory cells, and complete blood count
  • Tissue biomarker panel [ Time Frame: Assessed from tissue obtained on day of bronchoscopy and day of surgical resection ]
    Includes evaluation of cellular constituents and sequencing of cells present in tissue
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Intratumoral Cisplatin for Resectable NSCLC
Official Title  ICMJE A Phase 1 Trial of Intratumoral Cisplatin for Early Stage, Resectable, Non-Small Cell Lung Cancer
Brief Summary


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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Small Cell Lung Cancer
Intervention  ICMJE Drug: cis-diamminedichloroplatinum
Cisplatin delivered bronchoscopically at the time of diagnosis of NSCLC
Other Name: cisplatin
Study Arms  ICMJE Experimental: Intratumoral Cisplatin Arm
Single arm approach. There is no comparator or placebo group. Cisplatin will be administered directly into a non-small cell lung cancer, following imaging verification and pathologic diagnosis, during a single bronchoscopic procedure.
Intervention: Drug: cis-diamminedichloroplatinum
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 18, 2021)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2023
Estimated Primary Completion Date March 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ardren Sara 8026563795
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT04809103
Other Study ID Numbers  ICMJE 00001101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party C. Matthew Kinsey MD, MPH, University of Vermont
Study Sponsor  ICMJE University of Vermont
Collaborators  ICMJE Johnson & Johnson
Investigators  ICMJE
Principal Investigator: C. Matthew Kinsey, MD, MPH University of Vermont
PRS Account University of Vermont
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP