Clinical trial · Interventional
PANK-003 Cell Injection Combined With Standard Adjuvant Chemotherapy After Surgery in Patients With Stage IIIA NSCLC
A Single-center, Single-arm Exploratory 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
NCT07043907CI-TRIAL-00091607not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IIIA Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PANK-003 cell injection combined with standard postoperative adjuvant chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PANK-003 cell injection combined with standard postoperative adjuvant chemotherapy
- interventionNames
- Drug: PANK-003 cell injection combined with standard postoperative adjuvant chemotherapy
Primary outcomes (2)
- measure
- Incidence and severity of adverse events (AEs)
- timeFrame
- 3 months
- description
- Incidence, severity and clinically significant abnormal laboratory findings of treatment related AEs.
- measure
- Disease Free Surviva Percentage(DFS%)
- timeFrame
- 1 year
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.References
Publications (0)
Data not yet available
No reference posted for this study.