This study is a multicenter randomized controlled clinical trial targeting subjects with advanced or metastatic squamous NSCLC with unknown or negative gene status, aiming to evaluate the efficacy and safety of first-line delayed administration of Serplulimab combined with a low-dose Nab-Paclitaxel doublet chemotherapy regimen.
Sign a written informed consent before implementing any trial-related procedures;
Age ≥18 years and ≤75 years;
Histologically or cytologically confirmed locally advanced (IIIB-IIIC), metastatic, or recurrent (stage IV) squamous NSCLC (according to the 8th edition TNM lung cancer staging by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer), not suitable for surgery and radical concurrent chemoradiotherapy, and subjects who have not previously received systemic treatment;
Unknown gene status, or known histological specimen gene status confirming no EGFR gene-sensitive mutations or ALK gene fusion variations;
Pathology is adenocarcinoma or small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC;
Received radiotherapy before the first study drug administration, meeting one of the following conditions: ≥30% of bone marrow received radiotherapy within 14 days before treatment; lung lesion radiotherapy with a dose >30Gy within 6 weeks before treatment (subjects must have recovered to grade 1 or below from previous radiotherapy toxicity, without the need for corticosteroid treatment, and no history of radiation pneumonitis); palliative radiotherapy completed within 7 days before the first study drug administration;
Diagnosed with other malignancies other than NSCLC within 5 years before the first administration (excluding completely treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or completely resected carcinoma in situ);
Currently participating in an interventional clinical study treatment or received other study drugs or investigational devices within 4 weeks before the first administration;
Parallel
Serplulimab, Nab-Paclitaxel, Carboplatin
DrugStandard Dose Group (Control Group): Every three weeks is one cycle, with intravenous infusion on the first day of each cycle of Nab-Paclitaxel 260 mg/m², carboplatin AUC5, and serplulimab 4.5 mg/kg. Low Dose Group (Experimental Group): Every three weeks is one cycle, with intravenous infusion on the first day of each cycle of Nab-Paclitaxel 195 mg/m², carboplatin AUC3.75, and intravenous infusion of serplulimab 4.5 mg/kg on the third day.
The objective response rate (ORR)
The progression free survival (PFS)
The disease control rate (DCR)
The duration of remission (DOR)
The overall survival (OS)
Click on the lead sponsor to view all of their trials.
