A Prospective Trial Evaluating the Efficacy and Tumor Immune Microenvironment Remodeling Induced by SFI Plus PD-1 Inhibitors and PBC in Resectable 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.

Sex

All

Minimum age

18 Years

Maximum age

75 Years

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.

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