Xingbai Ji Formula Combined with Chemotherapy and Sintilimab in Metastatic Multi-Target Mutation-Negative Non-Small Cell Lung Cancer: a Clinical Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Xingbaiji Formula.
- Who it may be relevant to
- Registry 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. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Clinical Study of Xingbaiji Formula in Combination with Chemotherapy and Sintilimab As First-Line Treatment for Metastatic Multi-Target Mutation-Negative Non-Small Cell Lung Cancer
Overview
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.
Detailed description
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.
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
Primary outcome measures
- Objective Response Rate (ORR) [Time frame: six months]
Secondary outcome measures (2)
- Progression-Free Survival(PFS) [Time frame: 1 year]
- Disease Control Rate（DCR） [Time frame: six months]
Eligibility criteria
Inclusion criteria
- Signed written informed consent.
- Age: 18-75 years, regardless of gender.
- 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).
- ECOG performance status ≤2 and life expectancy ≥3 months.
- Histologically or cytologically documented ineligibility for EGFR, ALK, or ROS-1 targeted therapies (written evidence required).
- 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.
- 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
- History of or concurrent other malignancies (excluding non-invasive tumors such as cured basal cell carcinoma of the skin, cervical carcinoma in situ, etc.);
- Individuals with allergic reactions to the Xingbaiji formula;
- Patients with mixed small cell lung cancer or those with a small cell lung cancer component;
- Severe mental illness or cognitive impairment that would impede compliance with study protocols or follow-up requirements;
- 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);
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Jiangxi Provincial People's Hospital — Nanchang
Identifiers
NCT: NCT06848426 · 202510200