drugset / Trial / NCT06896890

Cisplatin (CIS) Administered As Dry Powder for Inhalation (DPI) in Patients with Stage IV Non-Small Cell Lung Cancer

NCT06896890 ↗

Phase 1/2 Recruiting 32 enrolled Inhatarget Therapeutics
NaSingle-groupOpen-labelTreatment

Summary

The combination of chemotherapy and immunotherapy shows promising results in terms of overall survival (OS) and progression-free survival (PFS) for the treatment of first-line stage IV non-small cell lung cancer (NSCLC) patients, leading to such combinations becoming a real backbone of the Standard of Care (SoC) for NSCLC patients. However, conventional chemotherapy's severe systemic toxicities represent a limiting factor in terms of administered dose and frequency. Administration of cisplatin by inhalation (pulmonary route) is a promising additional approach that may overcome the limitations of conventional chemotherapy. Use of a dry powder inhaler enables a high therapeutic response by delivering high local concentrations of a well-established active substance without the usual undesired reactions that limit the use of high doses when administered through the conventional systemic route. This study may provide insights into whether this add-on treatment might be a safe and potentially efficacious option for NSCLC patients.

Timeline

Start
2023-06-23
Primary completion
2026-10-01
Completion
2026-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 2.5 mg Inhaled
Subject Cisplatin Other / unclassified 5 mg Inhaled
Subject Cisplatin Other / unclassified 10 mg Inhaled
Subject Cisplatin Other / unclassified 30 mg Inhaled