Recruiting PHASE1, PHASE2 NSCLC (advanced Non-small Cell Lung Cancer)

New treatment option for NSCLC (advanced Non-small Cell Lung Cancer)

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

ClinicalTrials.gov ID: NCT06896890

What this study is testing

What is CIS-DPI?

CIS-DPI is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for nsclc (advanced non-small cell lung cancer).

Also referred to as Cisplatin-based Dry Powder for Inhalation.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • The patient must be ≥18 years of age at the time of signing the informed concent form (ICF).
  • The patient must have a pathologically or cytologically confirmed Stage IV NSCLC that could be treated with pembrolizumab alone or combined with...
  • The patient must have measurable disease according to RECIST 1.1.
  • The patient must be treatment naïve for stage IV NSCLC at the time of study enrolment. Patients having received, at least 6 months before D1...
  • The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

You likely can't join if

  • Patients with contraindication to or unwillingness to undergo contrast-enhanced computed tomography (CT) scans and chest X-rays according to the...
  • Patients who are participating in an investigational drug or device study within 4 weeks prior to the planned day for the first study treatment...
  • Patients who have been treated by any anti-neoplastic agent within 6 months prior to the planned day for the first study treatment administration...
  • Patients who have received prior therapy with an immune checkpoint inhibitor.
  • Patients who have received prior radiotherapy (head, neck, thorax, or abdomen) within 4 weeks prior to the planned day for the first study treatment...
  • Patients with concurrent thoracic irradiation for the treatment of lung cancer.
See the full eligibility criteria
Who can join
  • The patient must be ≥18 years of age at the time of signing the informed concent form (ICF).
  • The patient must have a pathologically or cytologically confirmed Stage IV NSCLC that could be treated with pembrolizumab alone or combined with carboplatin/pemetrexed or paclitaxel.
  • The patient must have measurable disease according to RECIST 1.1.
  • The patient must be treatment naïve for stage IV NSCLC at the time of study enrolment. Patients having received, at least 6 months before D1, platinum derivatives adjuvant after (i) surgery or (ii) concomitant...
  • The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • The patient must have adequate organ function values as follows:
  • Haematology:
  • Platelet count \>100,000 cells/mm3.
  • Absolute neutrophil count \>1,500 cells/mm3.
  • Haemoglobin \>9 g/dL.
  • Serum creatinine less or equal to upper limit of normal (ULN) or creatinine clearance \>60 mL/min/1.73 m2 on the basis of Cockcroft-Gault glomerular filtration rate estimation.
  • Coagulation:
  • International normalised ratio (INR) ≤1.5; for patients treated with coumarins INR ≤3 is acceptable.
  • Prothrombin time (PTtest) and activated partial thromboplastin time (aPTT) \<1.6 x ULN unless therapeutically warranted.
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<3 x ULN. In case of hepatic metastasis, AST and ALT \<5 x ULN.
  • Bilirubin ≤1.5 x ULN, except for patients with known familial hyperbilirubinemia (such as Gilbert syndrome); for patients with documented Gilbert's syndrome (Gilbert-Meulengracht syndrome) total bilirubin of ≤3 x ULN is...
  • The patient must have a resting oxygen saturation of at least 90%, a FEV1 ≥50% of predicted values as determined by spirometry and a DLCO of at least 50%.
  • The patient is able to manipulate adequately the refillable single-dose (RS01) capsule-based device.
  • Women of childbearing potential should have a negative serum pregnancy test, and be not pregnant or breastfeeding at screening.
  • Male patients that are able to father children and female patients of childbearing potential must agree to use highly effective methods of contraception throughout the study and for at least 6 months after the last dose...
  • The patient has given written informed consent prior to any study-specific procedures.
  • The patient has the willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
What rules you out
  • Patients with contraindication to or unwillingness to undergo contrast-enhanced computed tomography (CT) scans and chest X-rays according to the protocol requirements.
  • Patients who are participating in an investigational drug or device study within 4 weeks prior to the planned day for the first study treatment administration (D1).
  • Patients who have been treated by any anti-neoplastic agent within 6 months prior to the planned day for the first study treatment administration (D1).
  • Patients who have received prior therapy with an immune checkpoint inhibitor.
  • Patients who have received prior radiotherapy (head, neck, thorax, or abdomen) within 4 weeks prior to the planned day for the first study treatment administration (D1) except palliative radiotherapy (2 weeks). Patients...
  • Patients with concurrent thoracic irradiation for the treatment of lung cancer.
  • Patients who underwent major surgery within 4 weeks before the planned day for the first study treatment administration (D1).
  • Patients with EGFR activating mutation or ALK translocation, or any other activable molecular alterations that in the opinion of the investigator could be more effectively treated with targeted therapies (Note: This...
  • Non-smoking patients without results of Epidermal growth factor receptor (EGFR) mutation and anaplastic large-cell lymphoma kinase (ALK) translocation before the planned day for the first study treatment administration...
  • Patients with known pre-existing hearing impairment due to VIII nerve alteration.
  • Patients presenting a history of previous severe intolerance to or sensitivity to cisplatin, vitamin E or lactose.
  • Patients with mouth problems (e.g. cleft palate) or other abnormalities that would prevent tight fit of the mouth seal.
  • Patients with uncontrolled symptomatic pleural effusion or uncontrolled pneumothorax.
  • Patients having undergone pneumonectomy or bilobectomy (except if bilobectomy includes the right middle lobe).
  • Patients with a known history of severe cough/bronchospasm upon inhalation of dry powder inhalation products.
  • Patients with a known history or current evidence of any chronic upper or lower respiratory conditions (other than asthma and allergic or non-allergic rhinitis). History of mild acute upper or lower respiratory...
  • Patients with a known history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, acute exacerbation of chronic obstructive pulmonary disease (COPD) in the last 3...
  • Patients with uncontrolled asthma, as defined in the Global Initiative for Asthma (GINA) 2020 guidelines. Patients with (i) a history of asthma or (ii) controlled active asthma treated with long-acting beta-2 mimetics...
  • Patients with uncontrolled or severe active infection.
  • Known positivity for human immunodeficiency virus (HIV) or history of HIV (HIV testing is not mandatory):
  • Active hepatitis B virus (HBV; chronic or acute) defined as having a positive hepatitis B surface antigen (HBsAg) test at screening. Patients with past or resolved HBV infection (defined as having a negative HBsAg test...
  • Active hepatitis C virus (HCV) infection defined as having a positive HCV antibody test followed by a positive HCV ribonucleic acid (RNA) test at screening. The HCV RNA test will be performed only for patients who have...
  • Positivity for Coronavirus Disease 2019 (COVID-19) by PCR testing. PCR result must not be older than 72 hours prior to the planned day for the first study drug administration (D1). Completed vaccination or prior...
  • Live virus vaccine within 30 days prior to the planned day for the first study treatment administration (D1) (Note: inactivated seasonal flu vaccine is acceptable).
  • Patients using oral corticosteroids within 4 weeks1 week prior to the planned day for the first study treatment administration (D1) above daily dose of 10 mg or any single dose of 16 mg. Patients receiving inhaled or...
  • Patients who are presenting persistent toxicities greater than or equal to Common Terminology Criteria for Adverse Events (CTCAE version 5.0) grade 2 caused by previous cancer therapy (except for clinically...
  • Patients having a current active malignancy with the exception of adequately-treated basal or squamous cell carcinoma of the skin, preinvasive carcinoma of the cervix, in situ carcinoma of the breast or low-grade...
  • Patients with a known history of arterial thromboembolic event (ATE) or venous thromboembolic event (VTE) within 3 months prior to the planned day for the first study treatment administration (D1).
  • Patients with a known history of any of the following conditions: presyncope or syncope of either unexplained or cardiovascular etiology, uncontrolled ventricular arrhythmia (including but not limited to ventricular...
  • Patients with significant or uncontrolled congestive heart failure (CHF) with Left Ventricular Ejection Fraction Assessment (LVEF) of less than 40%, significant or uncontrolled myocardial infarction or significant...
  • Patients who have uncontrolled hypertension defined as systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥90 mmHg despite standard medical management with ≥2 anti-hypertensive drugs.
  • Patients with a known history of organ transplant or current active immunosuppressive therapy (such as cyclosporine, tacrolimus).
  • Patients with known history or presence of clinically relevant central nervous system (CNS) pathology, any autoimmune disease or significant coagulation disorder.
  • Patients with carcinomatous meningitis or CNS metastases, except where such metastases are stable and already irradiated.
  • Patients with peripheral neuropathy \>grade 1.
  • Patients with any significant medical condition that in the opinion of the investigator makes participation in the trial against the patients' best interests.
  • Patients who are unwilling or unable to comply with the study protocol for any other reason.

The study team makes the final eligibility decision.

Where it's taking place

  • Brussels, Belgium
  • Charleroi, Belgium
  • Jolimont, Belgium
  • Kortrijk, Belgium
  • Liège, Belgium
  • Mons, Belgium
  • Roeselare, Belgium
  • Boulogne-Billancourt, France
  • Caen, France
  • Paris, France
  • Saint-Herblain, France
  • Barcelona, Spain
  • Madrid, Spain
  • Seville, Spain

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Brussels, Belgium; Charleroi, Belgium; Jolimont, Belgium; Kortrijk, Belgium; Liège, Belgium; Mons, Belgium and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

ObesityType 2 diabetesType 1 diabetesPrediabetesWeight lossMetabolic syndromeHigh cholesterolHigh triglyceridesHigh blood pressurePCOSHypothyroidismThyroid diseaseGoutFatty liver disease (NAFLD/NASH)Heart failureCoronary artery disease

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.