OncoMatch/Clinical Trials/NCT05543330
A Phase Ib/II Clinical Trial of M701 in the Treatment of Malignant Pleural Effusions Caused by NSCLC
Is NCT05543330 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including M701 pleural infusion and Cisplatin pleural infusion for malignant pleural effusions.
Treatment: M701 pleural infusion · Cisplatin pleural infusion — This is a phase 1/phase 2, multicenter, open-label study to evaluate the safety, tolerability, PK, PD, immunogenicity and preliminary efficacy of M701 in patients with treatment of malignant pleural effusions caused by NSCLC.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Disease stage
Required: Stage IV
Metastatic disease required
NSCLC Stage IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Lab requirements
Blood counts
ANC ≥ 1.5 ×10^9/L, platelet count ≥ 100 ×10^9/L, hemoglobin ≥ 8.5 g/dL (without blood transfusion within 14 days of the first dose of study drug)
Kidney function
serum creatinine ≤ 1.5 x ULN
Liver function
bilirubin (TBIL) ≤ 1.5 x ULN, AST and ALT ≤ 3 x ULN (≤ 5 x ULN in case of liver metastases)
Bone marrow: absolute neutrophil count (ANC) ≥ 1.5 ×10^9/L, platelet count ≥ 100 ×10^9/L, hemoglobin ≥ 8.5 g/dL (without blood transfusion within14 days of the first dose of study drug); Liver: bilirubin (TBIL)≤ 1.5 x upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤ 3 x ULN ( ≤ 5 x ULN in case of liver metastases); Kidney: serum creatinine ≤1.5 x ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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