OncoMatch/Clinical Trials/NCT07647094
A Prospective, Multicenter, Randomized Controlled Study on the Efficacy and Safety of Low-dose Carboplatin Combined With Nab-Paclitaxel and Delayed Administration of Serplulimab as First-line Treatment for Advanced Squamous Non-small Cell Lung Cancer
Is NCT07647094 recruiting? Yes, currently enrolling (Jul 2026). This Early Phase 1 trial studies Serplulimab, Nab-Paclitaxel, Carboplatin for nsclc.
Treatment: Serplulimab, Nab-Paclitaxel, Carboplatin — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: ALK wild-type
Required: EGFR wild-type
Disease stage
Required: Stage IIIB, IIIC, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
ECOG performance status 0-1
Demographics
Prior therapy
Cannot have received: anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy
Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs targeting another stimulatory or co-inhibitory T cell receptor (e.g., CTLA-4, OX-40, CD137)
Cannot have received: systemic anti-tumor treatment for advanced/metastatic disease
Exception: Subjects who previously received platinum-containing adjuvant/neoadjuvant chemotherapy, or radical chemoradiotherapy for progressed disease, may be included if disease progression or recurrence occurs at least 6 months after the last chemotherapy drug treatment
No prior systemic anti-tumor treatment for advanced/metastatic disease. Subjects who previously received platinum-containing adjuvant/neoadjuvant chemotherapy, or radical chemoradiotherapy for progressed disease, may be included if disease progression or recurrence occurs at least 6 months after the last chemotherapy drug treatment
Lab requirements
Blood counts
ANC ≥1.5 x 10⁹/L (no G-CSF in past 14 days); platelets ≥100 × 10⁹/L (no transfusion in past 14 days); hemoglobin >9 g/dL (no transfusion or erythropoietin in past 14 days)
Kidney function
serum creatinine ≤1.5x ULN and creatinine clearance ≥60 ml/min
Liver function
total bilirubin ≤1.5x ULN; AST/ALT ≤2.5x ULN (≤5x ULN if liver metastases)
Cardiac function
myocardial enzyme spectrum within normal range; no significant and severe uncontrollable abnormalities in ECG rhythm, conduction, or morphology; no unstable angina, congestive heart failure, NYHA class ≥2, or recent myocardial infarction (<6 months)
Sufficient organ function: subjects must meet the following laboratory criteria: ... Absolute neutrophil count (ANC) ≥1.5 x 10⁹/L ... platelet count ≥100 × 10⁹/L ... hemoglobin >9 g/dL ... total bilirubin ≤1.5x ULN ... AST/ALT ≤2.5x ULN (≤5x ULN if liver metastases) ... serum creatinine ≤1.5x ULN and creatinine clearance ≥60 ml/min ... good coagulation function ... normal thyroid function ... myocardial enzyme spectrum within the normal range
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07647094 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy, systemic anti-tumor treatment for advanced/metastatic disease disqualifies patients from enrollment.
Does this trial require ALK?
Yes, ALK wild-type is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR wild-type is a required biomarker for enrollment.
What disease stage is eligible?
Stage IIIB or IIIC or IV is required.
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.
Check if I qualifyRelated pages