OncoMatch/Clinical Trials/NCT05978284
Study of ZG006 in Participants With Small Cell Lung Cancer or Neuroendocrine Carcinoma
Is NCT05978284 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies ZG006 for small cell lung cancer.
Treatment: ZG006 — This is a multi-center, open-label, Phase Ⅰ/Ⅱ clinical study of ZG006 for the treatment of participants with small cell lung cancer or neuroendocrine carcinoma who had no standard treatment available, or were intolerant to standard treatment.
Check if I qualifyExtracted eligibility criteria
Cancer type
Small Cell Lung Cancer
Neuroendocrine Tumor
Biomarker criteria
Required: DLL3 any tested (testing required; no eligibility threshold specified)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard treatment
who had no standard treatment available, or were intolerant to standard treatments
Cannot have received: anti-DLL3 drug
Anti-DLL3 and anti-CD3 drugs (including investigational drugs)
Cannot have received: anti-CD3 drug
Anti-DLL3 and anti-CD3 drugs (including investigational drugs)
Cannot have received: chemotherapy
Exception: ≤ 4 weeks before the study entry
Chemotherapy, biotherapy, endocrine therapy (except for hormone replacement), and biological targeted medicines ≤ 4 weeks before the study entry
Cannot have received: biotherapy
Exception: ≤ 4 weeks before the study entry
Chemotherapy, biotherapy, endocrine therapy (except for hormone replacement), and biological targeted medicines ≤ 4 weeks before the study entry
Cannot have received: endocrine therapy
Exception: ≤ 4 weeks before the study entry (except for hormone replacement)
Chemotherapy, biotherapy, endocrine therapy (except for hormone replacement), and biological targeted medicines ≤ 4 weeks before the study entry
Cannot have received: biological targeted medicine
Exception: ≤ 4 weeks before the study entry
Chemotherapy, biotherapy, endocrine therapy (except for hormone replacement), and biological targeted medicines ≤ 4 weeks before the study entry
Cannot have received: local palliative radiotherapy
Exception: ≤ 2 weeks (or 5 half-lives, whichever is longer) before the study entry
Local palliative radiotherapy and a small molecule targeted therapy ≤ 2 weeks (or 5 half-lives, whichever is longer) before the study entry
Cannot have received: small molecule targeted therapy
Exception: ≤ 2 weeks (or 5 half-lives, whichever is longer) before the study entry
Local palliative radiotherapy and a small molecule targeted therapy ≤ 2 weeks (or 5 half-lives, whichever is longer) before the study entry
Cannot have received: systemic immunosuppressive medication (corticosteroid)
Exception: doses > 10 mg/day prednisone or equivalent dose within 14 days prior to the study entry
Systemic immunosuppressive medications, such as corticosteroid (doses > 10 mg/day prednisone or equivalent dose) within 14 days prior to the study entry
Cannot have received: vaccine
Exception: within 4 weeks of study entry
Use of any vaccines against viral infections (COVID-19, influenza, varicella, etc.) within 4 weeks of study entry
Cannot have received: blood transfusion
Exception: within 14 days prior to study entry
Received any blood transfusion, EPO, G-CSF, albumin infusion and renal replacement therapy within 14 days prior to study entry
Cannot have received: EPO
Exception: within 14 days prior to study entry
Received any blood transfusion, EPO, G-CSF, albumin infusion and renal replacement therapy within 14 days prior to study entry
Cannot have received: G-CSF
Exception: within 14 days prior to study entry
Received any blood transfusion, EPO, G-CSF, albumin infusion and renal replacement therapy within 14 days prior to study entry
Cannot have received: albumin infusion
Exception: within 14 days prior to study entry
Received any blood transfusion, EPO, G-CSF, albumin infusion and renal replacement therapy within 14 days prior to study entry
Cannot have received: renal replacement therapy
Exception: within 14 days prior to study entry
Received any blood transfusion, EPO, G-CSF, albumin infusion and renal replacement therapy within 14 days prior to study entry
Lab requirements
Blood counts
ANC ≥ 1.5×10^9/L, PLT ≥ 75×10^9/L, Hemoglobin (Hb) ≥ 100 g/L
Kidney function
Creatinine clearance (Cockcroft-Gault formula) ≥ 50 mL/min
Liver function
ALT and AST < 3×ULN (< 5×ULN for liver metastases); TBIL < 1.5×ULN; albumin ≥ 30g/L
Cardiac function
No acute MI, unstable angina, stroke, or coronary angioplasty/stent within 6 months; NYHA class II-IV CHF or LVEF < 50% or lower limit of normal excluded; Uncontrollable hypertension (SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg) excluded; QTc(F) > 480 ms excluded
The main organ function meets any of the following criteria within 7 days prior to study entry; Hematological function: ANC < 1.5×10^9/L, PLT < 75×10^9/L, Hemoglobin (Hb) < 100 g/L; Hepatic function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 3×ULN, ALT and AST ≥ 5×ULN for liver metastases patients; Total bilirubin (TBIL) ≥ 1.5×ULN; albumin < 30g/L; Creatinine clearance (Cockcroft-Gault formula) < 50 mL/min; INR > 1.5 or APTT > 1.5×ULN; Severe cardiac-cerebral vascular disease, including but not limited to: Acute myocardial infarction, unstable angina, stroke, or received coronary angioplasty or stent implantation within 6 months before study entry; New York Heart Association functional class II to IV congestive heart failure or left ventricular ejection fraction (LVEF) < 50% or the lower limit of normal; Uncontrollable hypertension (even though the best treatment is used but systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg). QTc (F) interval prolonged in electrocardiography during the screening baseline period (> 480 ms)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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