RecruitingPhase 1Phase 2NCT06896890

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

A Phase I/II First-in-human Trial Investigating Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Ascending Doses of a Dry Powder Cisplatin Formulation for Inhalation to Treat Stage IV Non-small Cell Lung Cancer Patients


Sponsor

Inhatarget Therapeutics

Enrollment

32 participants

Start Date

Jun 23, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new way of delivering cisplatin — a standard chemotherapy drug — by inhaling it as a dry powder directly into the lungs, rather than receiving it intravenously (through a vein). This approach aims to deliver the drug more precisely to lung tumors while potentially reducing the systemic side effects that occur when it travels through the whole body. The study includes patients with stage IV non-small cell lung cancer (NSCLC) who would normally receive pembrolizumab-based treatment. **You may be eligible if...** - You are 18 years or older - You have confirmed stage IV NSCLC that is eligible for treatment with pembrolizumab (alone or with carboplatin/pemetrexed or paclitaxel) - You have measurable disease on imaging - You have not previously received systemic treatment for your lung cancer - Your lung function is adequate for inhaled therapy **You may NOT be eligible if...** - You have small cell lung cancer or another non-NSCLC type - You have certain genetic mutations that are targeted by approved therapies (like EGFR or ALK) - You have active or uncontrolled brain metastases - You have significant lung disease (such as severe COPD or interstitial lung disease) that would make inhaled therapy unsafe - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCIS-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).


Locations(15)

Institut Jules Bordet - Hôpital Universitaire de Bruxelles

Brussels, Belgium

GHDC

Charleroi, Belgium

CHU Helora - Site Jolimont

Jolimont, Belgium

AZ Groeninge

Kortrijk, Belgium

CHU Sart Tilman

Liège, Belgium

CHU Ambroise Paré

Mons, Belgium

AZ Delta

Roeselare, Belgium

Université Paris-Saclay, UVSQ, APHP - Hôpital Ambroise Paré

Boulogne-Billancourt, France

Centre François Baclesse de Caen

Caen, France

Hôpital Européen Georges Pompidou, Paris-Cite University

Paris, France

L'Institut de Cancérologie de l'Ouest

Saint-Herblain, France

Instituto Oncologico Dr Rosell, Hospital Universitario Dexeus

Barcelona, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario La PAZ, IdiPAZ

Madrid, Spain

Hospital Universitario Virgen del Rocío

Seville, Spain

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NCT06896890


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