OncoMatch/Clinical Trials/NCT06896890
Cisplatin (CIS) Administered As Dry Powder for Inhalation (DPI) in Patients with Stage IV Non-Small Cell Lung Cancer
Is NCT06896890 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies CIS-DPI for nsclc (advanced non-small cell lung cancer).
Treatment: CIS-DPI — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR activating mutation
Patients with EGFR activating mutation ... could be more effectively treated with targeted therapies (Note: This exclusion criterion must be checked before the first SoC administration)
Required: ALK translocation
Patients with ... ALK translocation ... could be more effectively treated with targeted therapies (Note: This exclusion criterion must be checked before the first SoC administration)
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-neoplastic agent
Exception: adjuvant platinum derivatives after surgery or concomitant chemoradiotherapy for unresectable locally advanced NSCLC, completed at least 6 months before 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)
Cannot have received: immune checkpoint inhibitor
Patients who have received prior therapy with an immune checkpoint inhibitor
Cannot have received: radiotherapy
Exception: palliative radiotherapy (2 weeks)
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)
Lab requirements
Blood counts
Platelet count >100,000 cells/mm3; ANC >1,500 cells/mm3; Haemoglobin >9 g/dL
Kidney function
Serum creatinine ≤ ULN or creatinine clearance >60 mL/min/1.73 m2 (Cockcroft-Gault)
Liver function
AST and 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 total bilirubin of ≤3 x ULN is acceptable.
adequate organ function values as follows: ... Platelet count >100,000 cells/mm3; ANC >1,500 cells/mm3; Haemoglobin >9 g/dL ... Serum creatinine ≤ ULN or creatinine clearance >60 mL/min/1.73 m2 ... AST and 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 total bilirubin of ≤3 x ULN is acceptable.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify