NCT04809103

Intratumoral Cisplatin for Resectable NSCLC

A Phase 1 Trial of Intratumoral Cisplatin for Early Stage, Resectable, Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University of Vermont · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	cis-diamminedichloroplatinum	Cisplatin delivered bronchoscopically at the time of diagnosis of NSCLC

Timeline

• Start date: 2021-03-08
• Primary completion: 2025-10-01
• Completion: 2025-10-01
• First posted: 2021-03-22
• Last updated: 2026-02-06
• Results posted: 2026-02-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study