Using Modified Si Jun Zi Tang with chemotherapy for lung cancer treatment

A Multi-center, Prospective, Exploratory Study Evaluating the Efficacy and Safety of a Modified Si Jun Zi Tang Formula in the Perioperative Treatment of Non-small Cell Lung Cancer

This study tests if adding a traditional Chinese medicine called Modified Si Jun Zi Tang to standard chemotherapy and immunotherapy can help people with non-small cell lung cancer do better during and after surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: First Affiliated Hospital of Zhejiang University (Academic / other)
• Drugs / interventions: immunotherapy, Chemotherapy
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06445881 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of Modified Si Jun Zi Tang, a traditional Chinese medicine, when added to standard chemotherapy and immunotherapy for patients with non-small cell lung cancer (NSCLC) during the perioperative phase. The study aims to determine if this combination can enhance the R0 resection rate and objective response rate, as well as improve safety outcomes. Additionally, it will assess the impact on 1-year and 2-year disease-free survival rates post-surgery. Biological samples will be collected to identify tumor markers related to treatment efficacy and prognosis.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with pathologically confirmed resectable or potentially resectable NSCLC and good performance status.

Not a fit: Patients with prior treatment for NSCLC or those with clinical stages outside II-IIIB may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve surgical outcomes and survival rates for patients with resectable NSCLC.

How similar studies have performed: While traditional Chinese medicine has been used in adjunctive roles, the specific combination of Modified Si Jun Zi Tang with chemotherapy and immunotherapy in this context is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 and ≤ 75 years.
2. Pathologically confirmed non-small cell lung cancer (NSCLC) with no prior treatment for this tumor.
3. Clinical stage II-IIIB (N2) tumors assessed as resectable or potentially resectable by a multidisciplinary team (MDT).
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 - 1.
5. Adequate organ function, including:

   Bone marrow: Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L, platelets ≥ 80 x 10\^9/L, hemoglobin ≥ 90 g/L.

   Liver: Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) ≤ 3 times ULN.

   Kidneys: Creatinine clearance rate ≥ 45 mL/min (using the standard Cockcroft-Gault formula) or ≤ 1.5 times ULN.
6. At least one measurable lesion according to RECIST v1.1 criteria.
7. For women: Must be surgically sterilized, postmenopausal, or use highly effective contraception during and for 3 months after treatment; must not be pregnant or breastfeeding during the treatment period.
8. Patients must have compliance and geographic proximity to ensure adequate follow-up.

Exclusion Criteria:

1. Patients with a history of autoimmune diseases, active tuberculosis, active hepatitis (HBV DNA \<2000 IU), or HIV infection.
2. Patients expected to be unable to tolerate surgery, such as those with severe cardiopulmonary insufficiency or coagulation disorders (APTT \<1.5 times ULN, INR \>2.0, PT \>16 seconds).
3. History of other malignancies within the past 2 years, except for cured cervical carcinoma in situ, basal cell carcinoma of the skin, superficial bladder cancer \[Ta, Tis \& T1\], or papillary thyroid carcinoma.
4. Any unstable systemic disease (including active systemic infections requiring systemic treatment, liver disease, kidney disease, or metabolic disorders, acute cerebral infarction or cerebral hemorrhage, etc.).
5. Significant cardiovascular events: congestive heart failure \> NYHA Class 2; unstable angina, active coronary artery disease (CAD) (myocardial infarction over 1 year before study entry is allowed); severe arrhythmias requiring treatment (use of beta-blockers or digoxin is allowed) or uncontrolled hypertension.
6. Significant neurological or psychiatric disorders, including epilepsy, dementia, etc.
7. Patients with interstitial lung disease or a history of interstitial pneumonia.
8. Participation in other anti-tumor drug clinical trials within 4 weeks prior to enrollment.
9. Previous use of PD-1/PD-L1 inhibitors or other anti-tumor immunotherapy drugs.
10. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation or planned transplantation.
11. Known allergy to the drugs or drug excipients used in the study or severe allergic reactions to other monoclonal antibodies.
12. Presence of other severe physical or laboratory abnormalities that may increase the risk of participating in the study, interfere with study results, or any other condition that, in the investigator's judgment, may affect the conduct or results of the clinical study.

Where this trial is running

Hangzhou, Zhejiang

• the First Affilated Hospital of Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Jianzhen Shan, MD — the First Affiliated Hospital of Zhejiang Universtiy
• Study coordinator: Jianzhen Shan, MD

Conditions Non Small Cell Lung Cancer; Perioperative Complication