Non Small Cell Lung CancerPhase 2MSJZT-NSCLCNCT06445881

Efficacy and Safety of Modified Si Jun Zi Tang in Perioperative NSCLC Treatment

A Phase 2 study testing Modified Si Jun Zi Tang in people with Non Small Cell Lung Cancer and Perioperative Complication, run by First Affiliated Hospital of Zhejiang University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Non Small Cell Lung Cancer, Perioperative Complication
What is being tested?: Modified Si Jun Zi Tang
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteChina
Study dates: 1 Jun 2024to 31 Dec 2026
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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.
At least one measurable lesion according to RECIST v1.1 criteria.
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.
Patients must have compliance and geographic proximity to ensure adequate follow-up.

Who cannot join

Patients with a history of autoimmune diseases, active tuberculosis, active hepatitis (HBV DNA <2000 IU), or HIV infection.
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).
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.
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.).
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.
Significant neurological or psychiatric disorders, including epilepsy, dementia, etc.

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Patients with interstitial lung disease or a history of interstitial pneumonia.
Participation in other anti-tumor drug clinical trials within 4 weeks prior to enrollment.
Previous use of PD-1/PD-L1 inhibitors or other anti-tumor immunotherapy drugs.
Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation or planned transplantation.
Known allergy to the drugs or drug excipients used in the study or severe allergic reactions to other monoclonal antibodies.
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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jianzhen Shan, MD contact

Zhen Liu, MD contact

China1 site, 1 recruiting

the First Affilated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
Jianzhen Shan, MD, +86-571-87235409, jianzhenshan@163.com
Zhen Liu, MD, +86-571-87235407, liuzhen@cancer.ac.cn
Recruiting

Other trials in China

About this study

Official title: 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

Chemotherapy combined with immunotherapy is the current standard perioperative treatment for non-small cell lung cancer (NSCLC). However, this regimen has multiple side effects and shows variable efficacy among individuals. In China, adjunctive traditional Chinese medicine is widely accepted by lung cancer patients. Modified Si Jun Zi Tang, a classic formula in traditional Chinese medicine, is known for its benefits in unifying and strengthening the spleen. This study aims to evaluate whether the addition of Modified Si Jun Zi Tang to chemotherapy and immunotherapy during the neoadjuvant phase can improve the R0 resection rate, objective response rate (ORR), and safety in patients with resectable and potentially resectable NSCLC. Secondary objectives include assessing whether this combination can improve 1-year and 2-year disease-free survival (DFS) post-surgery. Additionally, we will collect relevant biological samples to identify tumor markers associated with efficacy, prognosis, and side effects, providing a theoretical basis for modernizing and standardizing traditional Chinese medicine.

Conditions: Non Small Cell Lung Cancer, Perioperative Complication
Being tested: Modified Si Jun Zi Tang
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Modified Si Jun Zi TangDrug
Modified Si Jun Zi Tang is a classic formula in traditional Chinese medicine, known for its benefits in unifying and strengthening the spleen.

Study groups in NCT06445881
Study group	Role	What they receive
Modified Si Jun Zi Tang Combined with Chemotherapy and Immunotherapy	Experimental	Participants will receive Modified Si Jun Zi Tang combined with chemotherapy (albumin-bound paclitaxel or pemetrexed + carboplatin) and PD1 monoclonal antibody, followed by surgery if feasible. Postoperatively, they will continue with Modified Si Jun Zi Tang and PD1 monoclonal antibody for up to one year. Receives: Drug: Modified Si Jun Zi Tang
Standard Chemotherapy and Immunotherapy	No intervention	Participants will receive standard chemotherapy (albumin-bound paclitaxel or pemetrexed + carboplatin) and PD1 monoclonal antibody, followed by surgery if feasible. Postoperatively, they will continue with PD1 monoclonal antibody for up to one year.

What is being measured

The primary outcome is the main question the study is designed to answer.

R0 Resection Rate
The proportion of patients achieving complete surgical resection with negative margins (R0 resection) after neoadjuvant therapy.
Measured: Assessed at the time of surgery, approximately 2-4 months after starting treatment.
Objective Response Rate (ORR)
The proportion of patients achieving partial or complete response as defined by RECIST v1.1 criteria.
Measured: Assessed after 2 cycles of treatment (approximately 6 weeks) and before surgery, if applicable.
Incidence of Adverse Reactions
The proportion of patients experiencing treatment-related adverse reactions, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Measured: Assessed throughout the treatment period, from the start of treatment up to one year post-surgery.

Secondary outcomes (2)

1-Year Disease-Free Survival (DFS)
The proportion of patients who remain free of disease recurrence or progression one year after surgery.
Measured: Assessed one year post-surgery.
2-Year Disease-Free Survival (DFS)
The proportion of patients who remain free of disease recurrence or progression two years after surgery.
Measured: Assessed two years post-surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 202431 Dec 2026

First posted6 Jun 2024
Study start1 Jun 2024
Primary completion31 Dec 2025 (estimated)
Study completion31 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06445881
Sponsor's protocol ID: IIT20240018C-R1
Acronym: MSJZT-NSCLC
Status last verified: Jun 2024
First submitted: 2 Jun 2024
Last updated: 6 Jun 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT06445881
Acronym / sponsor ID: MSJZT-NSCLC / IIT20240018C-R1
Conditions: Non Small Cell Lung Cancer, Perioperative Complication
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 60 participants (estimated)
Lead sponsor: First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
Study start: 1 Jun 2024 (actual)
Primary completion: 31 Dec 2025 (estimated)
Study completion: 31 Dec 2026 (estimated)
First posted: 6 Jun 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Modified Si Jun Zi Tang Combined with Chemotherapy and Immunotherapy	Experimental	Drug: Modified Si Jun Zi TangParticipants will receive Modified Si Jun Zi Tang combined with chemotherapy (albumin-bound paclitaxel or pemetrexed + carboplatin) and PD1 monoclonal antibody, followed by surgery if feasible. Postoperatively, they will continue with Modified Si Jun Zi Tang and PD1 monoclonal antibody for up to one year.
Standard Chemotherapy and Immunotherapy	No intervention	–Participants will receive standard chemotherapy (albumin-bound paclitaxel or pemetrexed + carboplatin) and PD1 monoclonal antibody, followed by surgery if feasible. Postoperatively, they will continue with PD1 monoclonal antibody for up to one year.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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

Key exclusion criteria (12 listed)

Patients with a history of autoimmune diseases, active tuberculosis, active hepatitis (HBV DNA <2000 IU), or HIV infection.
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).
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.
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.).
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Modified Si Jun Zi TangModified Si Jun Zi Tang is a classic formula in traditional Chinese medicine, known for its benefits in unifying and strengthening the spleen.	Drug	Modified Si Jun Zi Tang Combined with Chemotherapy and Immunotherapy

Primary outcome

R0 Resection Rate
Time frame: Assessed at the time of surgery, approximately 2-4 months after starting treatment.
The proportion of patients achieving complete surgical resection with negative margins (R0 resection) after neoadjuvant therapy.
Objective Response Rate (ORR)
Time frame: Assessed after 2 cycles of treatment (approximately 6 weeks) and before surgery, if applicable.
The proportion of patients achieving partial or complete response as defined by RECIST v1.1 criteria.
Incidence of Adverse Reactions
Time frame: Assessed throughout the treatment period, from the start of treatment up to one year post-surgery.
The proportion of patients experiencing treatment-related adverse reactions, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

2 secondary outcomes

1-Year Disease-Free Survival (DFS)
Time frame: Assessed one year post-surgery.
2-Year Disease-Free Survival (DFS)
Time frame: Assessed two years post-surgery.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Jianzhen Shan, MD contact

Zhen Liu, MD contact

Jianzhen Shan, MD principal investigator

the First Affiliated Hospital of Zhejiang Universtiy

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Modified Si Jun Zi Tang in people with Non Small Cell Lung Cancer and Perioperative Complication, run by First Affiliated Hospital of Zhejiang University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jianzhen Shan, MD (+86-571-87235409, jianzhenshan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

R0 Resection Rate (time frame: Assessed at the time of surgery, approximately 2-4 months after starting treatment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06445881.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.