OncoMatch/Clinical Trials/NCT07096882
SDTM001 Injection as Adjuvant Therapy for NSCLC Patients After Radical Surgical Resection
Is NCT07096882 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies SDT-M001 for non-small cell lung cancer.
Treatment: SDT-M001 — The goal of this clinical trial is to evaluate the safety profile and tolerability of SDT-M001 injection in NSCLC patients with driver-gene-negative and negative PD-L1 expression after radical surgical resection; to determine the recommended Phase II dose (RP2D).
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR wild-type
Previous tests for driver gene mutations (e.g., EGFR, ALK) were negative
Required: ALK wild-type
Previous tests for driver gene mutations (e.g., EGFR, ALK) were negative
Required: PD-L1 (CD274) negative expression (negative)
PD-L1 expression in tumor tissues was negative as detected
Disease stage
Required: Stage IIA, IIB, IIIA, IIIB
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy
Platinum-based chemotherapy (one to four cycles) has been completed before screening
Must have received: radical surgical resection
have undergone radical surgical resection (R0) treatment
Cannot have received: gene-modified anti-tumor immune cell therapy (CAR-T cells, CAR-NK cells)
Participants who underwent gene-modified anti-tumor immune cell therapy (e.g., CAR-T cells, CAR-NK cells) within one year
Cannot have received: non-gene-modified anti-tumor immune cell therapy (NK cells, DC cells, DC-CIK cells)
non-gene-modified therapy (e.g., NK cells, DC cells, DC-CIK cells) within half a year prior to screening
Cannot have received: chemotherapy
Participants who have received cancer treatment such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks prior to screening
Cannot have received: radiotherapy
Participants who have received cancer treatment such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks prior to screening
Cannot have received: biological therapy
Participants who have received cancer treatment such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks prior to screening
Cannot have received: targeted therapy
Participants who have received cancer treatment such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks prior to screening
Cannot have received: immunotherapy
Participants who have received cancer treatment such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks prior to screening
Cannot have received: other clinical trial
Participants who have participated in other clinical trials of investigational agents or devices for therapeutic intent within 4 weeks prior to screening
Lab requirements
Blood counts
WBC ≥3.5×10^9 cells/L, LYM ≥0.8×10^9 cells/L, PLT ≥80×10^9 cells/L, absolute neutrophil count ≥1.5×10^9 cells/L, hemoglobin ≥90g/L
Kidney function
Creatinine ≤1.0×ULN, or creatinine clearance rate ≥60mL/min (Cockcroft-Gault method)
Liver function
Total bilirubin ≤1.5×ULN, ALT ≤2.5×ULN, AST ≤2.5×ULN
Cardiac function
No impaired cardiac function or significant cardiovascular diseases; acute MI or unstable angina ≤6 months prior to screening; NYHA III/IV CHF; uncorrected severe arrhythmia and hypertension ≥150/100 mmHg; prolonged QTc interval (>450ms in males, >470ms in females); history of other significant cardiovascular diseases
Major organ functions must be normal (no corrective treatment with any blood components, cell growth factors, or albumin infusion within 14 days before obtaining laboratory tests) and meet the following requirements: ... cardiac function or significant cardiovascular diseases, including any of the following: (1) Acute myocardial infarction or unstable angina pectoris ≤6 months prior to screening; (2) New York Heart Association classified III/IV congestive cardiac failure; (3) Uncorrected severe arrhythmia and hypertension ≥150/100 mmHg; (4) Prolonged QTc interval (> 450ms in males , > 470ms in females); (5) History of other significant cardiovascular diseases (e.g., valve replacement surgery, coronary artery bypass grafting).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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