Stage IIIA Non-small Cell Lung Cancer
Conditions
Brief summary
A Single-center, Single-arm Clinical Trial on the Safety and Efficacy of PANK-003 Cell Injection Combined with Standard Adjuvant Chemotherapy After Surgery in Patients with Stage IIIA Non-Small Cell Lung Cancer
Detailed description
This study is a single-center, single-arm, open-label, single-dose administration dose-finding study, which aims to evaluate the safety and efficacy characteristics of PANK-003 Cell Injection Combined with Standard Adjuvant Chemotherapy After Surgery in Patients with Stage IIIA Non-Small Cell Lung Cancer. The study includes a screening period, a treatment period, and an observation and follow-up period. The main objectives : To evaluate the safety and efficacy of multiple injections of PANK-003 cell injection combined with standard postoperative adjuvant chemotherapy in the treatment of patients with Stage IIIA Non-Small Cell Lung Cancer. Primary Endpoints： Safety Endpoints: Incidence and severity of investigator-assessed adverse events (AEs), and clinically significant abnormal laboratory findings. Efficacy Endpoint: 1-year DFS% assessed by the Independent Radiology Review Committee according to RECIST 1.1 criteria.
Interventions
DRUGPANK-003 cell injection combined with standard postoperative adjuvant chemotherapy
PANK-003 cell injection combined with standard postoperative adjuvant chemotherapy
Sponsors
Shenzhen Celconta Life Science Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Voluntarily participate in the clinical trial; fully understand and be informed about this study and sign the informed consent form; 2. At the time of screening, the age should be between 18 and 75 years old (inclusive), regardless of gender; 3. Patients with histologically confirmed stage IIIA NSCLC (T4N0M0, T3-4N1M0, T1a-2bN2M0) who underwent R0 resection and received postoperative adjuvant chemotherapy (Exclusion of EGFR sensitizing mutations and ALK fusion); and who received the first dose of PANK-003 cell injection combined with postoperative adjuvant chemotherapy within 8 weeks after radical surgery.; 4. At the time of enrollment, the expected survival time is more than 6 Months; 5. The Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1; 6. At the time of screening, the laboratory tests should meet the following requirements: * White blood cell count ≥ 3.0×10⁹/L; * Neutrophil count ≥ 1.5×10⁹/L; * Lymphocyte count ≥ 0.5×10⁹/L; * Hemoglobin ≥ 90 g/L; * Platelets ≥ 75×10⁹/L; * Serum total bilirubin ≤ 2.0 × ULN (Upper Limit of Normal); for patients with a history/suspected Gilbert's syndrome, total bilirubin (TBIL) must be ≤ 3 × ULN. * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5× ULN; * Creatinine \< 1.5×ULN and endogenous creatinine clearance rate ≥ 50 mL/minute (Cockcroft-Gault method for calculating creatinine clearance rate: For men, creatinine clearance rate = \[(140 - age) × body weight (kg)\] / \[0.818 × creatinine (μmol/L)\]; For women, creatinine clearance rate = \[(140 - age) × body weight (kg) × 0.85\] / \[0.818 × creatinine (μmol/L)\]). 7. Female subjects of childbearing potential must have a negative serum pregnancy test at screening and be willing to use medically recognized highly effective contraception during the study and for at least 1 year after the last study treatment; male subjects with partners of childbearing potential must have undergone surgical sterilization or agree to use effective contraception during the study and for at least 1 year after the last study treatment; 8. Investigator-confirmed eligibility for study enrollment.
Exclusion criteria
1. NSCLC patients who have received neoadjuvant therapy; 2. Pregnant or lactating women; 3. History of other malignancies, except: * Cured non-melanoma skin cancer * Carcinoma in situ of the cervix * Localized prostate cancer * Superficial bladder cancer * Other malignancies with disease-free survival \>5 years; 4. Positive virology serology meeting any of: * HBsAg(+) and/or HBeAg(+) with HBe-Ab(+) and/or HBc-Ab(+) and HBV-DNA \> lower limit of quantification * HCV-Ab(+) * TP-Ab(+) * HIV-Ab(+); 5. Received investigational drugs or other cell-based immunotherapy within 28 days before screening; 6. Administration of live/attenuated vaccines within 4 weeks prior to NK cell infusion; 7. Medical conditions requiring systemic corticosteroid therapy or other immunosuppressive drug treatments during the study period as determined by the investigator; 8. Hypersensitivity to: * Any component of NK cell products (including serum albumin) * Common emergency medications or anesthetics; 9. Unstable cardiovascular diseases within 180 days pre-screening, including: * Unstable angina * Myocardial infarction * Heart failure (NYHA class ≥III) * Severe arrhythmia requiring medication * Cardiac angioplasty, coronary stenting, or CABG; 10. Any condition that may compromise protocol compliance or patient safety as determined by the investigator: * Poorly controlled diabetes * Uncontrolled infections * Central nervous system disorders * Bleeding/thrombotic diathesis * Poor compliance * Substance abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of adverse events (AEs) | 3 months | Incidence, severity and clinically significant abnormal laboratory findings of treatment related AEs. |
| Disease Free Surviva Percentage（DFS%） | 1 year | Disease Free Survival (DFS): The time from the first infusion day of PANK - 003 cell injection in subjects to the recurrence of the tumor (including local recurrence, regional recurrence, or distant metastasis) or death due to any cause. Disease Free Surviva Percentage（DFS%）: It refers to the proportion of subjects who have not experienced tumor recurrence or death at a specific follow-up time point, typically expressed as a percentage. Its core lies in using survival analysis methods, combined with the follow-up data of subjects, to estimate the disease-free survival probabilities at different time points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Free Survival (DFS) | 1 year | Disease Free Survival (DFS): The time from the first infusion day of PANK - 003 cell injection in subjects to the recurrence of the tumor (including local recurrence, regional recurrence, or distant metastasis) or death due to any cause. |
| Overall Survival (OS) | 1 year | Overall Survival (OS):The time from the date of first administration of PANK-003 cell injection to deathfrom any cause. |
| Tumor Recurrence Rate (TRR) | 1 year | Tumor Recurrence Rate (TRR): The proportion of subjects who experience tumor recurrence from the first infusion day of PANK-003 to the end of follow-up. |
Contacts
Primary ContactShuanghu Yuan
Outcome results
None listed