Neoadjuvant With Tα1 Plus Immuno-chemotherapy for Resectable NSCLC

NCT06607926 | Not Yet Recruiting

• 1 other identifier: XWh-NSCLC-NEO-ZDX
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to explore the efficacy and safety of thymosin α-1 (Tα1) plus chemotherapy and PD-1 inhibitors as neoadjuvant therapy for operable non-small cell lung cancer

Conditions

Resectable Non-Small-Cell Lung Cancer

Keywords

non-small-cell lung cancer; resectable; thymosin alpha-1; PD-1 inhibitor; pCR

Outcome Measures

Primary Outcomes (1)

• Pathologic complete response rate

  The rate of no viable tumor cells in the resected specimen including lymph node region evaluated by H\&E staining

  at the time of surgey

Secondary Outcomes (3)

• major pathological response rate

  at the time of surgey

• Rate of R0 resection

  at the time of surgey

• Incidence of irAE

  From the first dose of PD-1 inhibitors to the three months after surgery

Study Arms (2)

Control group

ACTIVE COMPARATOR

Neoadjuvant therapy with platinum-doublet chemotherapy plus tislelizumab for four cycles, followed by surgery and adjuvant therapy.

Drug: Tislelizumab; Drug: Platinum-doublet chemotherapy

Experimental group

EXPERIMENTAL

Neoadjuvant therapy with platinum-doublet chemotherapy plus tislelizumab and Tα1 for four cycles, followed by surgery and adjuvant therapy.

Drug: Thymosin Alpha 1; Drug: Tislelizumab; Drug: Platinum-doublet chemotherapy

Interventions

Thymosin Alpha 1 DRUG

4.8 mg subcutaneous injection twice weekly over 12 weeks

Also known as: thymalfasin

Experimental group

Tislelizumab DRUG

200mg, IV, d1 of each 21-d cycle, four cycles

Control group; Experimental group

Platinum-doublet chemotherapy DRUG

Chemotherapy regimen: (1) for squamous cell carcinoma: cisplatin/carboplatin + paclitaxel; and (2) for non-squamous cell carcinoma: cisplatin/carboplatin + pemetrexed.

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females aged ≥ 18 years and ≤ 70 years
• With operable NSCLC confirmed by imaging studies and histopathology. (Stage II-IIIB\[N2\], according to the 8th Edition of the American Joint Committee on Cancer (AJCC-TNM) Staging Manual). Operable NSCLC, as defined by the Multidisciplinary Consensus Statement on the Clinical Management of Patients with Stage III Non-Small Cell Lung Cancer (2019 edition), includes resectable and potentially resectable cases. Resectable stage III NSCLC mainly includes stage IIIA N0-1, N2 with a single mediastinal lymph node metastasis and a short diameter \< 2 cm and some T4N1 (with solitary carcinomatous nodules in different lobes of the same lung). Potentially resectable stage III NSCLC includes some IIIA and IIIB tumors, usually including a single N2 mediastinal lymph node with a short diameter \< 3 cm, a potentially resectable superior sulcus tumor, and a potentially resectable T3 or T4 central tumor.
• Presence of at least one measurable lesion on imaging as per the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
• Negative for EGFR and ALK driver mutations
• With an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 - 1.
• With a life expectancy \> 6 months.
• No prior systemic treatment (including surgery, chemotherapy, radiotherapy, targeted therapy, or immunotherapy) for lung cancer.
• Informed consent to undergo radical surgery.
• No contraindications to surgery, as assessed by a thoracic surgeon.
• With adequate organ function, and with laboratory test results meeting the following criteria:
• Absolute neutrophil count (ANC) ≥ 1.5×10\^9/L without the use of granulocyte colony-stimulating factor in the past 14 days
• Platelet count ≥ 100×10\^9/L without blood transfusion in the past 14 days
• Hemoglobin (Hb) level ≥ 90 g/L without blood transfusion or erythropoietin administration in the past 14 days.
• Serum creatinine ≤ 1.5 × upper limit of normal (ULN) and creatinine clearance (calculated by the Cockcroft-Gault equation) ≥ 60 mL/min.
• Total bilirubin ≤ 1.5×ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN.

You may not qualify if:

• History of other malignancies within 5 years prior to the initial dose, excluding radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ following radical resection.
• Positive for EGFR and ALK driver mutations or unknown
• Ongoing participation in another interventional clinical trial, or receipt of other investigational agents or devices within 4 weeks prior to the first dose.
• Prior multidisciplinary treatment for lung cancer, including but not limited to surgery, radiotherapy, chemotherapy, and/or immunotherapy (e.g., PD-1 or PD-L1 inhibitors and CTLA-4 inhibitors).
• Use of systemic therapy with anti-tumor traditional Chinese patent medicines or immunomodulatory drugs (including thymopeptides, interferons, and interleukins, except for topical use for pleural effusions) within 2 weeks before the first dose.
• Active autoimmune disease necessitating systemic treatment (e.g., disease-modifying drugs, glucocorticoids, and immunosuppressants) within 2 years before the first dose. Replacement therapies such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency are not classified as systemic therapy.
• Use of systemic glucocorticoid therapy (excluding intranasal, inhaled, or other topical applications) or any other immunosuppressive treatment within 7 days before the first dose. Note: Glucocorticoids at physiological doses (≤ 10 mg/day of prednisone or equivalent) are allowed.
• History of allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
• Allergic to the active substance or excipients of the study drug.
• Incomplete recovery from toxicity and/or complications due to prior interventions (i.e., ≤ grade 1 or baseline, excluding fatigue and alopecia) before treatment initiation.
• Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV-1/2 antibody).
• Untreated active hepatitis B, defined as positive HBsAg along with HBV-DNA levels exceeding the ULN as determined by the clinical laboratory of the research center. Note: Subjects with hepatitis B may be eligible if they meet the following criteria:
• The HBV viral load is \< 1000 copies/mL (200 IU/mL) before the first dose, with subjects being required to undergo anti-HBV therapy throughout chemotherapy to prevent viral reactivation.
• For subjects with anti-HBc(+), HBsAg(-), anti-HBs(-), and HBV viral load (-), no HBV prophylaxis is required, although viral reactivation should be monitored closely.
• Subjects with active hepatitis C virus (HCV) infection, defined as positive HCV antibody and HCV-RNA levels above the threshold of detection.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, 100053, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Thymalfasin; tislelizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Thymosin; Thymus Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Proteins

Study Officials

• Yi Zhang

  Xuanwu Hospital, Beijing

  STUDY DIRECTOR

Central Study Contacts

Xin Zhao, MD

CONTACT

+86-010-83922345; zx89316@163.com

Yi Zhang, MD, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of thoracic surgery, Xuanwu Hospital

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 23, 2024
• Study Start: October 15, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 30, 2025
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)