Intratumoral Cisplatin for Resectable NSCLC
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|ClinicalTrials.gov Identifier: NCT04809103|
Recruitment Status : Recruiting
First Posted : March 22, 2021
Last Update Posted : March 22, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Cancer||Drug: cis-diamminedichloroplatinum||Phase 1|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Trial of Intratumoral Cisplatin for Early Stage, Resectable, Non-Small Cell Lung Cancer|
|Actual Study Start Date :||March 8, 2021|
|Estimated Primary Completion Date :||March 1, 2023|
|Estimated Study Completion Date :||September 1, 2023|
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.
Cisplatin delivered bronchoscopically at the time of diagnosis of NSCLC
Other Name: cisplatin
- Rate of dose limiting toxicity [ Time Frame: Within 2 weeks of delivery ]Adverse events as defined using the Common Terminology Criteria for Adverse Events
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04809103
|Contact: Ardren Saraemail@example.com|
|Principal Investigator:||C. Matthew Kinsey, MD, MPH||University of Vermont|