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

Launched by JIANGXI PROVINCIAL PEOPLE'S HOPITAL · Feb 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a traditional Chinese medicine called Xingbai Ji Formula when combined with standard chemotherapy and a drug called Sintilimab for patients with advanced non-small cell lung cancer (NSCLC) that does not have certain genetic mutations (EGFR, ALK, or ROS-1). The goal is to see if this combination treatment can help shrink tumors and improve patient outcomes. Researchers will also look at how long patients can live without the cancer getting worse and how the treatment affects their quality of life.

To participate in this trial, patients must be between 18 and 75 years old and have a confirmed diagnosis of NSCLC that has spread to other parts of the body (Stage IIIB-IV). They should not have received previous treatments for advanced cancer and must meet some health criteria. Participants will be randomly divided into two groups: one will receive only the standard treatment, while the other will receive the standard treatment plus the Xingbai Ji Formula for six months. Throughout the trial, patients will be monitored for side effects and how well the treatment works. This study is not yet recruiting participants, but it aims to provide new insights into treating advanced lung cancer.

Gender

ALL

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.