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

February 23, 2025 updated by: Weirong Yao, Jiangxi Provincial People's Hopital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Jiangxi Provincial People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm
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.
No Intervention: Control Arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate (ORR)
Time Frame: six months
six months

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-Free Survival(PFS)
Time Frame: 1 year
1 year
Disease Control Rate（DCR）
Time Frame: six months
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangxi Provincial People's Hopital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 10, 2025

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

January 31, 2028

Study Registration Dates

First Submitted

February 18, 2025

First Submitted That Met QC Criteria

February 23, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 23, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202510200

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe