Actively Recruiting
Cisplatin (CIS) Administered As Dry Powder for Inhalation (DPI) in Patients with Stage IV Non-Small Cell Lung Cancer
Led by Inhatarget Therapeutics · Updated on 2025-03-26
32
Participants Needed
15
Research Sites
170 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Cisplatin (CIS) Administered As Dry Powder for Inhalation (DPI) in Patients with Stage IV Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at consent
- Confirmed Stage IV non-small cell lung cancer suitable for treatment with pembrolizumab alone or with carboplatin/pemetrexed or paclitaxel
- Measurable disease by RECIST 1.1 criteria
- Treatment-naive for stage IV NSCLC; prior adjuvant platinum therapy allowed if completed over 6 months ago
- ECOG performance status of 0 or 1
- Adequate organ function: platelet count >100,000/mm3, neutrophils >1,500/mm3, hemoglobin >9 g/dL
- Serum creatinine ≤ upper limit of normal or creatinine clearance >60 mL/min/1.73 m2
- Coagulation parameters within specified limits (INR ≤1.5 or ≤3 if on coumarins; PT and aPTT <1.6 x ULN unless clinically warranted)
- AST and ALT <3 x ULN (or <5 x ULN if hepatic metastasis)
- Bilirubin ≤1.5 x ULN (up to 3 x ULN if Gilbert syndrome)
- Resting oxygen saturation ≥90%, FEV1 ≥50% predicted, DLCO ≥50%
- Able to use the single-dose capsule inhaler device
- Negative pregnancy test for women of childbearing potential; not pregnant or breastfeeding
- Agree to use effective contraception during study and for 6 months after last dose
- Provided written informed consent
- Willing and able to comply with study visits and procedures
You will not qualify if you...
- Contraindication or unwillingness to undergo contrast-enhanced CT scans or chest X-rays
- Participation in another investigational drug or device study within 4 weeks before first treatment
- Anti-neoplastic treatment within 6 months prior to first treatment
- Prior therapy with immune checkpoint inhibitors
- Radiotherapy within 4 weeks prior to first treatment except palliative radiotherapy (2 weeks), with recovery from toxicities and no corticosteroid requirement
- Concurrent thoracic irradiation
- Major surgery within 4 weeks before first treatment
- EGFR activating mutation, ALK translocation, or other targetable molecular alterations better treated with targeted therapies
- Non-smokers without EGFR and ALK mutation test results before first treatment
- Known hearing impairment due to VIII nerve damage
- History of severe intolerance or sensitivity to cisplatin, vitamin E, or lactose
- Mouth abnormalities preventing proper inhaler use
- Uncontrolled symptomatic pleural effusion or pneumothorax
- Previous pneumonectomy or bilobectomy (except if including right middle lobe)
- Severe cough or bronchospasm with dry powder inhalers
- Chronic respiratory conditions other than asthma or rhinitis; recent mild acute respiratory conditions resolved for at least 3 months
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, pneumonitis requiring steroids, recent COPD exacerbation, interstitial lung disease, or current pneumonitis
- Uncontrolled asthma per GINA 2020 guidelines; controlled asthma with less than one crisis monthly allowed
- Uncontrolled or severe active infections
- Known HIV infection or history
- Active hepatitis B or C infection not resolved
- Positive COVID-19 PCR test within 72 hours before first treatment
- Live virus vaccine within 30 days before first treatment
- Oral corticosteroids above specified doses within 4 weeks before first treatment; inhaled or topical corticosteroids allowed
- Persistent toxicities ≥ grade 2 from previous cancer therapy except alopecia
- Active malignancy except certain treated skin, cervical, breast, or prostate cancers; prior malignancy must be disease-free for 3 years
- Recent arterial or venous thromboembolic events within 3 months
- History of unexplained syncope or significant cardiac arrhythmias
- Significant or uncontrolled congestive heart failure or recent myocardial infarction
- Uncontrolled hypertension despite treatment
- History of organ transplant or ongoing immunosuppressive therapy
- Clinically relevant CNS pathology, autoimmune disease, or coagulation disorder
- Carcinomatous meningitis or unstable CNS metastases
- Peripheral neuropathy greater than grade 1
- Any other medical condition making participation unsafe or inability to comply with protocol requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Institut Jules Bordet - Hôpital Universitaire de Bruxelles
Brussels, Belgium
Actively Recruiting
2
GHDC
Charleroi, Belgium
Actively Recruiting
3
CHU Helora - Site Jolimont
Jolimont, Belgium
Actively Recruiting
4
AZ Groeninge
Kortrijk, Belgium
Actively Recruiting
5
CHU Sart Tilman
Liège, Belgium
Actively Recruiting
6
CHU Ambroise Paré
Mons, Belgium
Actively Recruiting
7
AZ Delta
Roeselare, Belgium
Actively Recruiting
8
Université Paris-Saclay, UVSQ, APHP - Hôpital Ambroise Paré
Boulogne-Billancourt, France
Not Yet Recruiting
9
Centre François Baclesse de Caen
Caen, France
Not Yet Recruiting
10
Hôpital Européen Georges Pompidou, Paris-Cite University
Paris, France
Not Yet Recruiting
11
L'Institut de Cancérologie de l'Ouest
Saint-Herblain, France
Not Yet Recruiting
12
Instituto Oncologico Dr Rosell, Hospital Universitario Dexeus
Barcelona, Spain
Actively Recruiting
13
Hospital Universitario 12 de Octubre
Madrid, Spain
Actively Recruiting
14
Hospital Universitario La PAZ, IdiPAZ
Madrid, Spain
Actively Recruiting
15
Hospital Universitario Virgen del Rocío
Seville, Spain
Actively Recruiting
Research Team
F
Frédéric De Coninck
CONTACT
W
Wendy Sonnet, MSc, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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