OncoMatch/Clinical Trials/NCT06987734
Neoadjuvant Sugemalimab + Chemotherapy Followed by Adjuvant Sugemalimab for Patients With Resectable Stage II-IIIA Non-small-cell Lung Cancer Patients
Is NCT06987734 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Neoadjuvant Sugemalimab + Chemotherapy Followed by Adjuvant Sugemalimab for lung cancer (nsclc).
Treatment: Neoadjuvant Sugemalimab + Chemotherapy Followed by Adjuvant Sugemalimab — This is a single arm, open-label exploratory study conducted in resectable stage II-IIIA NSCLC without EGFR/ALK mutations, aiming to investigate feasibility, safety and efficacy of Sugemalimab in perioperative contexts. Twenty-five resectable stage II-IIIA patients are planned to be enrolled. The proportion of patients with squamous cell carcinoma will not less than 40%. Combined neoadjuvant chemotherapy and immunotherapy with fixed dose of Sugemalimab 1200 mg IV Q3W + Platinum-based chemo in resectable stage II-IIIA NSCLC adult patients followed by surgery. After completion of neoadjuvant therapy (3-4 cycles) and before surgery, a tumor assessment will be done. Patients have to leave the study if there is evidence of progression in neoadjuvant therapy. Pathological response is planned to assessed after surgery. Following surgery, the patients with complete resection will receive an additional 1 year of Sugemalimab q3w. Treatment will commence as soon as clinically feasible post-surgery. Informed consent will be obtained prior to tissue collection and genome sequencing for each participant. Primary tumour tissue will be obtained at diagnosis by biopsy such as percutaneous lung puncture biopsy, bronchoscopic biopsy or endobronchial ultrasound (EBUS) (based on clinical practice). Fresh tumour tissue was collected after surgical resection. Tissues collected were subjected to medically necessary pathology for diagnosis. Specimens were processed for multiplex immunofluorescence, single-cell sequencing and spatial transcriptomics, bulk RNAseq and WES to explore the changes in the immune microenvironment before and after suglizumab administration.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR activating mutation in the TK domain
All patients carrying activating mutations in the TK domain of EGFR [excluded]
Required: ALK any variety of alterations
any variety of alterations in the ALK gene [excluded]
Disease stage
Required: Stage II, IIIA
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Any anti-tumor treatment within the past 5 years, including chemotherapy, radiotherapy, target therapy or other immunotherapy
Cannot have received: radiotherapy
Any anti-tumor treatment within the past 5 years, including chemotherapy, radiotherapy, target therapy or other immunotherapy
Cannot have received: targeted therapy
Any anti-tumor treatment within the past 5 years, including chemotherapy, radiotherapy, target therapy or other immunotherapy
Cannot have received: immunotherapy
Any anti-tumor treatment within the past 5 years, including chemotherapy, radiotherapy, target therapy or other immunotherapy
Cannot have received: antibody/drug that targets at T-cell coregulatory proteins
Any prior treatment of antibody/drug that targets at T-cell coregulatory proteins
Lab requirements
Blood counts
Hemoglobin ≥90g/L; ANC ≥1.5×10^9/L; Platelets ≥100×10^9/L
Kidney function
Creatinine ≤1.5x ULN or Creatinine Clearance rate ≥60 ml/min
Liver function
Total bilirubin ≤1.5x ULN; ALT and AST ≤2.5x ULN
Cardiac function
LVEF ≥ lower limit of normal value (50%)
Major organ function ... Hemoglobin（HB）≥90g/L； Absolute neutrophils count（ANC）≥1.5×109/L； Blood platelets（PLT）≥100×109/L ... Total bilirubin（TBIL）≤1.5 times the upper limit of normal (ULN) ； Alanine aminotransferase (ALT) and aspartate aminotransgerase AST≤2.5*ULN, Creatinine（Cr）≤1.5*ULN or Creatinine Clearance rate (CCr)≥60 ml/min; Coagulation test: INR/APTT within normal limits Doppler ultrasound assessment：left ventricular ejection fraction (LVEF) ≥the lower limit of normal value (50%).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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