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

NCT06896890 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-03-26

No results posted yet for this study

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.

Conditions

  • NSCLC (advanced Non-small Cell Lung Cancer)
  • Stage IV Lung Cancer

Interventions

DRUG

CIS-DPI

* Administration of cisplatin by inhalation (pulmonary route) using single-use RS01 capsule-based device and CIS-DPI hard capsules containing 2.5 mg, 5 mg, and 10 mg cisplatin. * CIS-DPI, administered once-a-day, 5-days on followed by 2-days off. Daily dose to be administered will range from an initial dose of 2.5 mg cisplatin to a maximal theoretical dose of 30 mg (i.e., dose 1 to dose 7).

Sponsors & Collaborators

  • Inhatarget Therapeutics

    lead INDUSTRY

Principal Investigators

  • Thierry Berghmans, Prof.MD. · Hopital Universitaire de Bruxelles (HUB)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Belgium
  • France
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06896890 on ClinicalTrials.gov