xingbai ji formula combined with chemotherapy and sintilimab in metastatic multi-target mutation-negative non-small cell lung cancer: a clinical trial

Conditions: Non-Small Cell Lung Cancer; Non-small Cell Lung Cancer Recurrent; Non-small Cell Lung Cancer Stage IIIB; Non-small Cell Lung Cancer Stage IV; Non-small Cell Lung Cancer Metastatic

Summary: clinical trial protocol primary objective: to evaluate the efficacy of the xingbaiji formula combined with chemotherapy and sintilimab as first-line therapy in patients with recurrent or metastatic stage iiib-iv egfr/alk/ros-1 mutation-negative non-small cell lung cancer (nsclc), using objective response rate (orr) of tumor lesions as the primary endpoint. secondary objectives: to assess secondary endpoints including progression-free survival (pfs), quality of life (qol), immune-related indicators, and safety profile (e.g., incidence of adverse events), and to further evaluate the efficacy and safety of the combination therapy. randomized group allocation: participants will be randomly assigned to two groups: control group regimen for advanced non-squamous nsclc: drugs and dosage: sintilimab 200mg + pemetrexed + cisplatin/carboplatin via intravenous infusion, administered every 3 weeks (q3w) for 4 cycles. after completion of 4 cycles, patients enter the maintenance phase: sintilimab 200mg q3w (up to 24 months) + pemetrexed q3w until disease progression, intolerable toxicity, death, or voluntary withdrawal. regimen for advanced squamous nsclc: drugs and dosage: sintilimab 200mg + gemcitabine + cisplatin/carboplatin via intravenous infusion, q3w for 4-6 cycles. post-treatment, patients receive sintilimab 200mg q3w maintenance until disease progression, intolerability, or completion of 2 years of sintilimab therapy. experimental group control group regimen + xingbaiji formula xingbaiji formula dosage: 1. granule no. 1: 10g/bag, dissolved in warm water. administration: 1 bag orally, twice daily (morning and evening), after meals. 2. granule no. 2: 5g/bag, dissolved in warm water. administration: 1 bag orally, twice daily (morning and evening), after meals. treatment duration: both granules are taken concurrently with chemotherapy for 6 months, then discontinued.

randomized clinical trial on xingbaiji formula combined with chemotherapy and sintilimab as first-line treatment for recurrent/metastatic stage iiib-iv egfr/alk/ros-1 mutation-negative non-small cell lung cancer primary objective: to evaluate efficacy by measuring objective response rate (orr) in patients receiving xingbaiji formula combined with chemotherapy and sintilimab. secondary objectives: to assess progression-free survival (pfs), quality of life (qol), immune-related biomarkers, safety, and adverse event rates. study arms control group non-squamous nsclc: sintilimab 200mg + pemetrexed + cisplatin/carboplatin (iv, q3w for 4 cycles). after induction, maintenance with sintilimab 200mg q3w (≤24 months) + pemetrexed q3w until disease progression, toxicity, or withdrawal. squamous nsclc: sintilimab 200mg + gemcitabine + cisplatin/carboplatin (iv, q3w for 4-6 cycles). maintenance with sintilimab 200mg q3w until progression or maximum 2 years. experimental group control regimen + xingbaiji formula: xingbaiji granule 1 (10g/sachet): dissolved in warm water, 1 sachet twice daily (morning/evening, post-meal). xingbaiji granule 2 (5g/sachet): dissolved in warm water, 1 sachet twice daily (morning/evening, post-meal). duration: concurrent with chemotherapy for 6 months, then discontinued.

Eligibility criteria:
inclusion criteria: 1. signed written informed consent. 2. age: 18-75 years, regardless of gender. 3. histologically or cytologically confirmed non-small cell lung cancer (nsccc), including adenocarcinoma, squamous cell carcinoma, or large cell carcinoma, with negative egfr, alk, and ros-1 mutations confirmed by next-generation sequencing (ngs). stage iiib-iv nsclc as per ajcc 8th edition staging criteria (required evaluations: neck contrast-enhanced ct or ultrasound, chest contrast-enhanced ct, abdominal contrast-enhanced ct or ultrasound, brain contrast-enhanced mri, bone scan, or whole-body pet/ct). 4. ecog performance status ≤2 and life expectancy ≥3 months. 5. histologically or cytologically documented ineligibility for egfr, alk, or ros-1 targeted therapies (written evidence required). 6. at least one measurable lesion per recist v1.1. lesions within prior radiation fields or post-local treatment may be selected if progression is confirmed. 7. no prior systemic anti-tumor therapy for advanced disease. adjuvant chemotherapy is permitted if ≥6 months have elapsed between recurrence and the last dose. exclusion criteria: 1. history of or concurrent other malignancies (excluding non-invasive tumors such as cured basal cell carcinoma of the skin, cervical carcinoma in situ, etc.); 2. individuals with allergic reactions to the xingbaiji formula; 3. patients with mixed small cell lung cancer or those with a small cell lung cancer component; 4. severe mental illness or cognitive impairment that would impede compliance with study protocols or follow-up requirements; 5. pregnant or lactating women (a pregnancy test must be performed to exclude pregnancy; women of childbearing age must agree to use effective contraception during the study); 6. presence of any major illness or significant laboratory abnormalities that may interfere with receiving xingbaiji formula, chemotherapy, or immunotherapy; 7any other conditions deemed by the investigators to render participation in the trial inappropriate.