Trial Title:
Neoadjuvant With Tα1 Plus Immuno-chemotherapy for Resectable NSCLC
NCT ID:
NCT06607926
Condition:
Resectable Non-Small-Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Tislelizumab
Thymalfasin
Conditions: Keywords:
non-small-cell lung cancer
resectable
thymosin alpha-1
PD-1 inhibitor
pCR
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Thymosin Alpha 1
Description:
4.8 mg subcutaneous injection twice weekly over 12 weeks
Arm group label:
Experimental group
Other name:
thymalfasin
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
200mg, IV, d1 of each 21-d cycle, four cycles
Arm group label:
Control group
Arm group label:
Experimental group
Intervention type:
Drug
Intervention name:
Platinum-doublet chemotherapy
Description:
Chemotherapy regimen: (1) for squamous cell carcinoma: cisplatin/carboplatin +
paclitaxel; and (2) for non-squamous cell carcinoma: cisplatin/carboplatin + pemetrexed.
Arm group label:
Control group
Arm group label:
Experimental group
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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
- Good coagulation, defined as prothrombin time/international normalized ratio
(INR) ≤ 1.5 × ULN.
- Normal thyroid function, defined as thyroid-stimulating hormone (TSH) level
within the reference range. Subjects with baseline TSH level beyond the normal
range may also be enrolled if total T3 (or free T3) and free T4 levels are
within the normal range.
- The cardiac enzyme levels are within the normal limits (enrollment is also
permitted if the investigator deems laboratory abnormalities as clinically
insignificant).
- Females of childbearing potential must agree to use contraceptive methods throughout
the study and for 6 months post-study. Patients must have a negative serum or urine
pregnancy test within 7 days prior to enrollment and should not be lactating. Male
patients must agree to use contraceptive methods throughout the study and for 6
months post-study.
- Subjects have full understanding of the study and voluntarily sign the informed
consent form before any trial-related procedure is initiated.
Exclusion Criteria:
- 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.
- Administration of a live vaccine within 30 days before the first dose. Note:
administration of inactivated influenza vaccine by injection within 30 days before
the first dose is allowed; however, subjects with a history of administration of
intranasal live attenuated influenza vaccines will be excluded.
- Pregnant or lactating women.
- Subjects with any severe or uncontrolled systemic condition, including but not
limited to:
- Significant resting ECG abnormalities in rhythm, conduction, or morphology
(e.g., complete left bundle branch block, second- and higher-degree heart
block, ventricular arrhythmias, or atrial fibrillation), corresponding to
severe and difficult-to-control symptoms.
- Unstable angina, congestive heart failure, or New York Heart Association (NYHA)
class ≥ 2 chronic heart failure.
- History of arterial thrombosis, embolism, or ischemia, including myocardial
infarction, unstable angina, cerebrovascular accident, or transient ischemic
attack, within 6 months preceding enrollment.
- Uncontrolled blood pressure, with systolic blood pressure (SBP) > 140 mmHg
or diastolic blood pressure (DBP) > 90 mmHg.
- History of non-infectious pneumonitis necessitating glucocorticoid therapy
within 1 year before the first dose, or current clinically active interstitial
lung disease.
- Active tuberculosis.
- Active or uncontrolled infection requiring systemic treatment.
- Clinically active diverticulitis, intra-abdominal abscess, or gastrointestinal
obstruction.
- Liver diseases, including cirrhosis, decompensated liver disease, and
acute/chronic active hepatitis.
- Poorly controlled diabetes mellitus, with fasting blood glucose (FBG) > 10
mmol/L.
- Urine protein ≥++ on routine urinalysis, along with a 24-hour urine protein
level of > 1.0 g.
- A psychiatric disorder that limits the patient's ability to comply with the
treatment or to follow the protocol.
- A history or current evidence of any condition, therapy, or laboratory abnormality
that might confound the results of the study, interfere with the subject's
participation for the full duration of the study; or, any condition that is judged
by the Investigator to be inappropriate for the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Xuanwu Hospital, Capital Medical University
Address:
City:
Beijing
Zip:
100053
Country:
China
Contact:
Last name:
Yi Zhang
Phone:
86-010-83922345
Email:
steven9130@sina.com
Investigator:
Last name:
Yi Zhang
Email:
Principal Investigator
Start date:
October 15, 2024
Completion date:
December 30, 2025
Lead sponsor:
Agency:
Xuanwu Hospital, Beijing
Agency class:
Other
Source:
Xuanwu Hospital, Beijing
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06607926
