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OncoMatch/Clinical Trials/NCT05979818

Propranolol Hydrochloride in Combination With Sintilimab and Platinum-based Chemotherapy for Treatment of Advanced Non-small Cell Lung Cancer

Is NCT05979818 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Propranolol hydrochloride and Sintilimab for non small cell lung cancer.

Phase 1RecruitingSecond Xiangya Hospital of Central South UniversityNCT05979818Data as of May 2026

Treatment: Propranolol hydrochloride · Sintilimab · ChemotherapyThis study is a prospective single-center Phase I clinical study in patients with EGFR/ALK/ROS1 driver oncogene negative, and advanced or metastatic NSCLC. This study is to evaluate the efficacy and safety preliminarily in a small-size of propranolol hydrochloride in combination with sintilimab and platinum-based chemotherapy in first-line therapy. Propranolol hydrochloride is a beta- adrenergic blocking agent which is associated with augment of immune cell responses. Propranolol hydrochloride may improve the responses of immune checkpoint inhibitors in treating patients with advanced NSCLC.

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Extracted eligibility criteria

Cancer type

Small Cell Lung Cancer

Biomarker criteria

Required: ALK wild-type

Required: EGFR wild-type

Required: ROS1 wild-type

Disease stage

Required: Stage IIIB, IIIC, IV

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: anti-PD-1 therapy

Prior exposure to any anti-PD-1 or anti-PD-L1, PD-L2, CD137, CTLA-4 antibody therapy, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

Cannot have received: anti-PD-L1 therapy

Prior exposure to any anti-PD-1 or anti-PD-L1, PD-L2, CD137, CTLA-4 antibody therapy, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

Cannot have received: anti-PD-L2 therapy

Prior exposure to any anti-PD-1 or anti-PD-L1, PD-L2, CD137, CTLA-4 antibody therapy, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

Cannot have received: anti-CTLA-4 therapy

Prior exposure to any anti-PD-1 or anti-PD-L1, PD-L2, CD137, CTLA-4 antibody therapy, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

Cannot have received: systemic cytotoxic chemotherapy

Exception: neoadjuvant/adjuvant chemotherapy or chemoradiotherapy completed ≥12 months prior to diagnosis of advanced/metastatic disease is permitted

Chemotherapy and chemoradiotherapy are permitted as neoadjuvant/adjuvant treatment as long as the treatment is completed at least 12 months prior to the diagnosis of advanced or metastatic disease

Lab requirements

Blood counts

absolute neutrophil count ≥ 1.5 x 10^9/L; platelet count ≥ 100 x 10^9/L; hemoglobin ≥ 9.0 g/dL (no blood transfusion or erythropoietin-dependent administration within 7 days)

Kidney function

serum creatinine ≤1.5 × ULN or Cr clearance ≥60 mL/min; urine protein <2+ or 24-hour urine protein quantification <1g

Liver function

total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN in absence of hepatic metastases; ALT or AST ≤ 5 × ULN with hepatic metastases

Cardiac function

NYHA classification < 3; LVEF ≥ 50%; Baseline ECG showed no PR interval lengthened or atrioventricular block

Meet the following laboratory indicators... Heart function: the New York heart association (NYHA) classification < 3;Left ventricular ejection fraction(LVEF)≥ 50%; Baseline ECG showed no PR interval lengthened or atrioventricular block

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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