Trial Title:
Serplulimab for Patients With Non-small Cell Lung Cancer (NSCLC) With TPS ≥ 50%: a Prospective, Single-center, Single-arm Phase 2 Study.
NCT ID:
NCT06195683
Condition:
Non-small Cell Lung Cancer
PDL1 Gene Mutation
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Participants with ⅠB(≥4cm)-ⅢA and TPS ≥ 50% non-small cell lung cancer patients,
excluding EGFR and ALK gene mutations. They will receive 4 cycles of Serplulimab
monotherapy at 4.5mg/kg as neoadjuvant treatment before surgery. Subsequently, they will
undergo surgical resection and the effectiveness of the neoadjuvant treatment will be
evaluated. After surgery, they will receive 14 cycles of Serplulimab as adjuvant
treatment.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Serplulimab
Description:
Serplulimab for 4.5mg/kg IV Q3W day 1,22,43,64
Arm group label:
anti-PDL-1 Immunotherapy followed by Surgical Resection
Summary:
The goal of this clinical trial is to observe the efficacy and safety of Serplulimab
monotherapy as a neoadjuvant treatment for TPS ≥ 50% non-small cell lung cancer (NSCLC).
Detailed description:
The study aims to explore new strategies for neoadjuvant treatment of resectable NSCLC
patients with TPS ≥ 50%, and to identify potential prognostic biomarkers.
Participants with stage ⅠB-ⅢA and TPS ≥ 50% non-small cell lung cancer, excluding EGFR
and ALK gene mutations will receive 4 cycles of Serplulimab monotherapy at 4.5mg/kg as
neoadjuvant treatment before surgery. Subsequently, they will undergo surgical resection
and evaluation of the effect of neoadjuvant therapy. 14 cycles of Serplulimab as adjuvant
treatment. Participants will provide blood samples before neoadjuvant treatment, before
the third cycle of neoadjuvant treatment, before surgery, and 4-7 days after surgery for
Minimal Residual Disease（MRD） detection to assist in evaluating the treatment effect.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Sign written informed consent
- The participant signs and dates a written informed consent form. The informed
consent form must be signed before any protocol-related procedures (not part of the
participant's routine medical care) are performed.
- The participant must be willing and able to comply with scheduled visits, treatment
regimens, and laboratory tests.
Participant types and target disease characteristics
-Eastern Cooperative Oncology Group (ECOG) performance status score 0-1 Histologically
confirmed non-small cell lung cancer, clinical stage IIB (tumors ≥4cm), II, IIIA (lymph
nodes limited to N1) according to the UICC lung cancer staging system (8th edition).
There are measurable lesions according to RECIST criteria.
- Participants must have tumor tissue samples available for PD-L1 (22c3 kit) IHC
testing, with PD-L1 expression ≥50%
- Within 3 months, lung function should reach at least FEV1>1.0L, FEV1%>40%.
According to the definition of laboratory test results described below, there is
sufficient hematology and vital organ function, and the test results need to be completed
within 14 days before the first study treatment:
1. Blood routine (within 14 days before the first study treatment without receiving
hematopoietic stimulating factors or blood transfusions): absolute neutrophil count
(ANC) ≥ 1.5 × 109/L, absolute lymphocyte count (LC) ≥ 0.5 × 109/L; platelet count
(PLT) ≥ 100 × 109/L, hemoglobin (Hb) ≥ 90g/L
2. Liver function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)
≤3 xULN; total bilirubin (TBIL) ≤1.5 x ULN (for patients with confirmed Gilbert
syndrome, total bilirubin ≤3.0 mg/dL); albumin (ALB) ≥3 g/dL;
3. Renal function: creatinine clearance rate (CrCl) ≥45mL/minute (using the
Cockcroft-Gault formula);
4. Coagulation function: international normalized ratio (INR) ≤1.5, activated partial
thromboplastin time (APTT) ≤1.5 x ULN;
5. Cardiac color Doppler ultrasound examination: left ventricular ejection fraction
(LVEF) ≥50% Age and fertility status Age ≥18 and ≤75. Women of childbearing age
(WOCBP) must have a negative serum or urine pregnancy test within 24 hours before
starting the study treatment (the minimum sensitivity of HCG is 25 IU/L or
equivalent units).
- Female must be in a non-lactating state
Exclusion Criteria:
Histologically or cytologically confirmed mixed SCLC and NSCLC, large cell neuroendocrine
carcinoma, and sarcomatoid carcinoma; NSCLC non-squamous histological type with EGFR
mutation-positive or ALK-positive subjects. Non-squamous subjects must undergo EGFR gene
testing and ALK gene and/or immunohistochemical testing, with TPS score <50%; Malignant
pleural effusion. If the subject has pleural effusion that can be aspirated during the
screening period, at least one pleural puncture is required to confirm the presence of
malignant cells; Previous systemic treatment for non-small cell lung cancer (including
clinical study medication) has been received. If the subject has previously received
traditional Chinese medicine for anti-tumor treatment, the end of the treatment must be
separated from the first study medication by a time interval of no less than 2 weeks;
Previous thoracic radiotherapy has been received; Participation in other clinical studies
within 4 weeks before the first dose or 5 half-lives of the study drug, whichever is
shorter; Systemic immune stimulation therapy (including but not limited to interferon or
interleukin-2, including immune stimulation agents in clinical trials) within 4 weeks
before the first dose; Systemic immunosuppressive therapy (including but not limited to
glucocorticoids, cyclophosphamide, azathioprine, methotrexate, thalidomide,
antineoplastic cytokines) within 2 weeks before the first dose or is expected to be
required during the study treatment period. Subjects who have received short-term,
low-dose (≤10mg/day prednisone or equivalent dose) systemic immunosuppressive drugs or
short-term high-dose systemic immunosuppressive drugs (such as for treatment of contrast
agent allergy with glucocorticoids for 48 hours) may be included in the study after
obtaining approval from the medical monitor. Subjects who use glucocorticoids (≤10mg/day
prednisone or equivalent dose) for treatment of chronic obstructive pulmonary disease,
mineralocorticoids for treatment of orthostatic hypotension, and physiological
replacement doses of glucocorticoids for treatment of adrenal insufficiency may be
included; There are autoimmune diseases. The following conditions are allowed: type I
diabetes (blood sugar can be controlled by insulin therapy); hypothyroidism caused by
autoimmune thyroiditis that only needs hormone replacement therapy; only vitiligo
dermatosis (psoriatic arthritis needs to be excluded); History of other malignancies
(except non-small cell lung cancer) within the screening period, excluding cervical
carcinoma in situ, basal cell or squamous cell skin cancer, localized prostatic cancer,
ductal carcinoma in situ, hormone replacement therapy for non-metastatic prostate cancer
or breast cancer; Known or suspected interstitial pneumonia or other serious lung
diseases that may interfere with lung toxicity testing or treatment, including
significant respiratory function impairment; Severe cardiovascular diseases such as NYHA
classification II or higher, myocardial infarction or cerebrovascular accident (stroke,
hemorrhagic stroke) within 3 months before the first dose, unstable arrhythmia or
unstable angina within 1 month before the first dose; Significant bleeding symptoms or
bleeding tendency within 1 month before the first dose, such as gastrointestinal
bleeding, gastric ulcer bleeding, or suffering from thromboangiitis obliterans; Deep
venous thrombosis and pulmonary embolism within 3 months before the first dose; HIV
positive; Active hepatitis B (HBsAg positive and HBV-DNA test result higher than the
upper limit of normal in the local laboratory during screening) or hepatitis C (HCV-Ab
positive and HCV-RNA positive during screening); Active tuberculosis infection within 1
year before the first dose; Serious infection within 4 weeks before the first dose,
including hospitalization and/or antibiotics treatment for ≥2 weeks for infections such
as sepsis, severe pneumonia, etc.; antibiotics treatment for active infections within 2
weeks before the study treatment; Vaccination with live attenuated vaccines within 28
days before the first dose; Major surgery within 28 days before the first dose; Previous
or planned allogeneic bone marrow transplantation or solid organ transplantation; History
of severe allergic reaction to other monoclonal antibody / fusion protein drugs; Allergic
to any component of the investigational product; Pregnant, breastfeeding, or planning to
become pregnant during the study period; Subjects with a history of substance abuse,
alcoholism, or drug addiction; The researchers believe that any other medical (such as
pulmonary, metabolic, endocrine, or neurological diseases, congenital diseases, etc.),
psychiatric, or social conditions that may interfere with the rights, safety, health, or
ability of the subjects to sign informed consent, collaborate and participate in the
study, or interfere with the evaluation of study drugs, interpretation of patient safety,
or study results.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Start date:
December 1, 2023
Completion date:
June 20, 2025
Lead sponsor:
Agency:
Zhejiang Cancer Hospital
Agency class:
Other
Source:
Zhejiang Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06195683
