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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 (Jun 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 Jun 2026Location: China

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

Treatments studied

Immunotherapy

Sintilimab

Other

Propranolol hydrochlorideChemotherapy

Cancer type

Non-Small Cell Lung Carcinoma

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)

Demographics

Ages ≤ 75

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.

Frequently asked questions

Is NCT05979818 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

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.

Does this trial require ROS1?

Yes, ROS1 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.

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