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 (Sep 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
Treatments studied
Chemotherapy
Other
Cancer type
Non-Small Cell Lung Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
ECOG score (PS) of 0-1 (for subjects with inadequately controlled malignant pleural effusion of whom ECOG score is 2 can be enrolled)
Demographics
Prior therapy
Must have received: systemic anti-tumor treatment
advanced non-small cell lung cancer that has progressed after at least one line of systemic anti-tumor treatment
Cannot have received: intrathoracic infusion of immune drugs (PD-1, PD-L1, CTLA-4, and other immune checkpoint inhibitors)
Exception: excluding interleukins
Subjects who have received intrathoracic infusion of immune drugs, such as PD-1, PD-L1, CTLA-4, and other immune checkpoint inhibitors (excluding interleukins)
Lab requirements
Blood counts
ANC ≥ 1.5 × 10^9/L, platelet ≥ 100 × 10^9/L, hemoglobin ≥ 85 g/L; no transfusion or correction with G-CSF or other hematopoietic stimulating factors within 14 days before first dose
Kidney function
serum creatinine ≤ 1.5 × ULN
Liver function
total bilirubin ≤ 1.5 × ULN, AST and ALT ≤ 3 × ULN (≤ 5 × ULN in case of liver metastasis), serum albumin > 28 g/L
Cardiac function
mean corrected QT interval (QTcF) > 450 ms (male) or > 470 ms (female) in 3 ECGs at screening; NYHA class III-IV cardiac insufficiency, acute cardiovascular event or pulmonary embolism within past 6 months, vascular stent implantation within past 6 months, new venous thrombotic disease within past 1 month
Organ functions must meet the following criteria: Hemogram (no transfusion of blood or blood products, no correction with granulocyte-colony stimulating factor (G-CSF) or other hematopoietic stimulating factors within 14 days before the first dose): absolute neutrophil count (ANC) ≥ 1.5 109/L, platelet (PLT) ≥ 100 109/L, and hemoglobin (HGB) ≥ 85 g/L; Hepatic function: total bilirubin (TBIL) ≤ 1.5 × ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN (AST and ALT ≤ 5 × ULN in case of liver metastasis), serum albumin > 28 g/L; Renal function: Serum creatinine (Cr) ≤ 1.5 × ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05543330 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior intrathoracic infusion of immune drugs (PD-1, PD-L1, CTLA-4, and other immune checkpoint inhibitors) disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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