Xingbai Ji Formula Combined with Chemotherapy and Sintilimab in Metastatic Multi-Target Mutation-Negative Non-Small Cell Lung Cancer: a Clinical Trial

NANot yet recruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

March 10, 2025

Primary Completion Date

June 30, 2027

Study Completion Date

January 31, 2028

Conditions
Non-Small Cell Lung CancerNon-small Cell Lung Cancer RecurrentNon-small Cell Lung Cancer Stage IIIBNon-small Cell Lung Cancer Stage IVNon-small Cell Lung Cancer Metastatic
Interventions
DRUG

Xingbaiji Formula

"Patients were randomized into two groups:~Control Group:~Non-squamous NSCLC: Sintilimab (200 mg) combined with pemetrexed + cisplatin/carboplatin, administered intravenously (IV) every 3 weeks (Q3W) for 4 cycles. After 4 cycles, maintenance therapy with sintilimab (200 mg Q3W, up to 24 months) + pemetrexed Q3W continued until disease progression, intolerable toxicity, death, or voluntary withdrawal.~Squamous NSCLC: Sintilimab (200 mg) combined with gemcitabine + cisplatin/carboplatin, IV Q3W for 4-6 cycles. Post-induction, sintilimab (200 mg Q3W) maintenance continued until progression, intolerance, or ≤2 years of treatment.~Experimental Group:~The control regimen plus Xingbaiji Formula:~Xingbaiji Granule 1: 10 g/bag, dissolved in warm water, 1 bag twice daily (morning and evening) after meals.~Xingbaiji Granule 2: 5 g/bag, dissolved in warm water, 1 bag twice daily (morning and evening) after meals."

Trial Locations (1)

330006

Jiangxi Provincial People's Hospital, Nanchang

All Listed Sponsors
lead

Jiangxi Provincial People's Hopital

OTHER