A Prospective Trial of SFI Plus PD-1 Inhibitors and PBC in Resectable NSCLC (SFI-NSCLC) (SFI-NSCLC)

October 27, 2026 updated by: Yue-Yin Pan, Anhui Provincial Cancer Hospital

A Prospective Trial Evaluating the Efficacy and Tumor Immune Microenvironment Remodeling Induced by Shenqi Fuzheng Injection Combined With Neoadjuvant PD-1 Inhibitors and Platinum-Based Chemotherapy in Resectable Locally Advanced NSCLC

This prospective, single-center clinical trial will enroll 30 treatment-naïve patients with locally advanced, resectable stage II-IIIA non-small cell lung cancer (NSCLC) to receive neoadjuvant Shenqi Fuzheng Injection (SFI) in combination with a PD-1 inhibitor and platinum-based chemotherapy. The primary endpoint is the pathological complete response (pCR) rate, while secondary endpoints include the major pathological response (MPR) rate and event-free survival (EFS). Furthermore, single-cell and spatial transcriptomics will be employed to dynamically track alterations in the immune regulatory network within the tumor microenvironment (TME) pre- and post-SFI administration. This approach aims to elucidate how SFI remodels the TME immune landscape and to uncover its potential advantages in improving clinical outcomes. Additionally, we will investigate the synergistic effects of SFI combined with PD-1 blockade and platinum-based chemotherapy, with the ultimate goal of advancing the integration of traditional Chinese medicine into the therapeutic paradigm for resectable NSCLC.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study plans to enroll 30 treatment-naïve patients with locally advanced, resectable non-small cell lung cancer (NSCLC). Enrolled patients will receive 2 to 3 cycles of neoadjuvant combination therapy, including Shenqi Fuzheng Injection (SFI), a PD-1 inhibitor, and platinum-based chemotherapy, followed by surgical resection 3 to 4 weeks after completion of treatment. The primary outcome measure is the pathological response rate of the tumor following surgery. Additionally, advanced genomic profiling techniques will be employed to analyze changes in the tumor immune microenvironment before and after treatment, with the aim of elucidating the underlying mechanisms of action of SFI.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Tian Tian Tian, Master's degree
  • Phone Number: 13866195758
  • Email: tiantian@ustc.com

Study Contact Backup

  • Name: Pan yueyin Chief Medical Officer of Clinical Research, Doctoral degree
  • Phone Number: 13805695539
  • Email: panyueyin@ustc.edu.cn

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 18 to 75 years, with a pathologically confirmed diagnosis of resectable stage IB (tumor diameter ≥4 cm), IIA or IIIA (AJCC 8th edition) NSCLC.

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with an estimated life expectancy ≥3 months.

No prior history of immunotherapy or platinum-based chemotherapy. No known EGFR mutations or ALK rearrangements. At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).

Adequate bone marrow reserve and vital organ function (ANC ≥1.5 × 10⁹/L, PLT ≥75 × 10⁹/L, Hb ≥90 g/L; hepatic and renal function parameters within 1.5 × ULN).

Voluntary participation and provision of written informed consent. Subjects of childbearing potential must agree to use effective contraceptive measures for at least 90 days after the last dose.

Exclusion Criteria:

  • Pregnant and/or lactating women; Women of childbearing potential with a positive serum pregnancy test; Unresectable or metastatic disease: tumor invasion into critical structures (e.g., vertebral body, carina, or heart) or tumor metastases, including M1 stage and brain metastases (unless neurologically asymptomatic and radiologically stable for ≥4 weeks following prior therapy); Severe comorbidities, including interstitial lung disease (ILD), defined as a documented history of or active ILD, and autoimmune diseases (e.g., systemic lupus erythematosus and rheumatoid arthritis) requiring systemic immunosuppressive therapy.

History of neurological or psychiatric disorders. Uncontrolled infections, uncontrolled hypertension, or severe primary diseases of the cardiovascular, hepatic, renal, or hematopoietic systems.

History of solid organ transplantation or chronic use of immunosuppressive therapy (including topical or local administration) Known hypersensitivity to Shenqi Fuzheng Injection or its excipients, or a history of allergic diathesis or multiple drug allergies.

Concurrent malignancy or a history of any other malignancy diagnosed within 5 years prior to randomization, except for adequately treated localized cancers (e.g., carcinoma in situ of the cervix, basal cell carcinoma, cutaneous squamous cell carcinoma, or papillary thyroid carcinoma).

Patients deemed unsuitable for study participation at the investigator's discretion or those who voluntarily withdraw consent prior to enrollment.

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: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SFI plus PD-1 and PBC

Patients received neoadjuvant Shenqi Fuzheng Injection (SFI; 250 mL intravenous infusion once daily for 10 consecutive days) in combination with a PD-1 inhibitor and platinum-based doublet chemotherapy. SFI administration commenced 2 days prior to the initiation of cycle 3 chemotherapy. Surgical resection was performed 3-4 weeks after completion of neoadjuvant therapy.
Drug: Shenqi Fuzheng Injection

Shenqi Fuzheng Injection (SFI) in combination with anti-PD-1 monoclonal antibody plus platinum-based doublet chemotherapy as neoadjuvant therapy.

SFI is administered starting 3 days before the third cycle of chemotherapy, given by intravenous infusion at a dose of 250 mL once daily for 10 consecutive days.

Other Names:
  • Carboplatin
  • Paclitaxel
  • PD-1 Inhibitor

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pathological Complete Response (pCR) Rate
Time Frame: Tumour tissue specimens were obtained at the time of surgery

Defined as the proportion of randomized subjects with no residual viable tumor in the lung and sampled lymph nodes, as assessed by a Blinded Independent Pathological Review (BIPR), divided by the total number of randomized subjects in the respective treatment group.
Tumour tissue specimens were obtained at the time of surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Major Pathological Response (MPR) Rate
Time Frame: From enrollment to surgery following neoadjuvant therapy.

Defined as the proportion of randomized subjects with ≤10% residual viable tumor in the lung and sampled lymph nodes, as assessed by BIPR, divided by the total number of subjects in the respective treatment group.
From enrollment to surgery following neoadjuvant therapy.
Recurrence-Free Survival (RFS)
Time Frame: From enrollment to 36 months post-treatment

Defined as the time interval from the date of surgery to the date of documented disease recurrence or the date of the last follow-up, whichever occurs first.
From enrollment to 36 months post-treatment
Radiological Complete Response (rCR) Rate
Time Frame: From Enrollment to Surgery After Neoadjuvant Therapy

Defined as the absence of contrast enhancement in the original tumor bed as demonstrated by contrast-enhanced mediastinal MRI. The rCR will be dynamically monitored at three timepoints: prior to neoadjuvant therapy, before the initiation of Cycle 3 of the immuno-chemotherapy regimen (i.e., prior to Shenqi Fuzheng Injection administration), and prior to surgical resection.
From Enrollment to Surgery After Neoadjuvant Therapy

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Anhui Provincial Cancer Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Livzon Pharmaceutical Group Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pan Yue Yin, Doctoral degree, Anhui Provincial Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 6, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026-LLYJ-0043
  • 2026-LLYJ-0043 (Registry Identifier: LZ-SFI-NSCLC-01)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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.

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