NCT04809103

Intratumoral Cisplatin for Resectable NSCLC

Completed Phase 1 Results posted Last updated 6 February 2026

What this trial tests

Phase 1 trial testing cis-diamminedichloroplatinum in Non-Small Cell Lung Cancer in 6 participants. Completed in 1 October 2025.

Timeline

8 March 2021

Primary endpoint
1 October 2025

1 October 2025

Quick facts

Lead sponsor	University of Vermont
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	8 March 2021
Primary completion	1 October 2025
Estimated completion	1 October 2025
Sites	1 location across United States

Drugs / interventions tested

• cis-diamminedichloroplatinum — full drug profile →

Conditions studied

• Non-Small Cell Lung Cancer — all drugs for Non-Small Cell Lung Cancer →

Sponsor

University of Vermont

Who can join

18 and older, any sex, with Non-Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Rate of Dose Limiting Toxicity Primary · Within 2 weeks of delivery

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

Group	Value	95% CI
Intratumoral Cisplatin Arm	0

Major Pathologic Response Secondary · Assessed on the surgical resection specimen, performed within 30 days of bronchoscopic delivery

Evaluation of the tissue response to the drug

Group	Value	95% CI
Intratumoral Cisplatin Arm	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 30 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intratumoral Cisplatin 10 mg

Serious: 0/3 (0%)

Deaths: 0/3

Intratumoral Cisplatin 20 mg

Serious: 0/3 (0%)

Deaths: 0/3

Other adverse events (2 terms — click to expand)

Reaction	System	Intratumoral Cisplatin 10 mg	Intratumoral Cisplatin 20 mg
Headache	General disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—

Data from ClinicalTrials.gov NCT04809103 adverse events section.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Trial watch: intratumoral immunotherapy.
   Humeau J, Le Naour J, Galluzzi L, Kroemer G, et al · · 2021 · cited 45× · PMID 34676147 · DOI 10.1080/2162402x.2021.1984677
2. Advantageous Reactivity of Unstable Metal Complexes: Potential Applications of Metal-Based Anticancer Drugs for Intratumoral Injections.
   Levina A, Crans DC, Lay PA. · · 2022 · cited 20× · PMID 35456624 · DOI 10.3390/pharmaceutics14040790
3. Real-World Impact of Robotic-Assisted Bronchoscopy on the Staging and Diagnosis of Lung Cancer: The Shape of Current and Potential Opportunities.
   Ortiz-Jaimes G, Reisenauer J. · · 2023 · cited 9× · PMID 37694262 · DOI 10.2147/por.s395806
4. Optimizing Therapeutics for Intratumoral Cancer Treatments: Antiproliferative Vanadium Complexes in Glioblastoma.
   Bates AC, Klugh KL, Galaeva AO, Patch RA, et al · · 2025 · cited 2× · PMID 39940763 · DOI 10.3390/ijms26030994
5. Intratumoral Treatment in Lung Cancer: Is It Time to Move Towards Clinical Practice?
   Pagliari GG, Colonese F, Canova S, Abbate MI, et al · · 2024 · cited 1× · PMID 39682081 · DOI 10.3390/cancers16233892
6. Linking Iron Metabolism, Ferroptosis, and Cancer: New Targets and Prospects for Effective Anticancer Therapeutic Interventions.
   Kourti M, Kontoghiorghes GJ. · · 2026 · PMID 42122232 · DOI 10.3390/cancers18091436
7. Direct pulmonary delivery route in lung cancer: a highway for siRNA therapeutics.
   Sharif MS, Luzzi L, De Laurentiis M, Giordano A, et al · · 2025 · PMID 41658564 · DOI 10.3389/fonc.2025.1722906