PANK-003 Cell Injection Combined With Standard Adjuvant Chemotherapy After Surgery in Patients With Stage IIIA NSCLC

NCT07043907 | Not Yet Recruiting Phase 2

• 1 other identifier: 2025-ETHICS COMMITTEE OPIN-038
• Study Type: interventional
• Target: 115
• Locations: 0 countries
• Sites: N/A

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

Conditions

Stage IIIA Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Incidence and severity of adverse events (AEs)

  Incidence, severity and clinically significant abnormal laboratory findings of treatment related AEs.

  3 months

• Disease Free Surviva Percentage（DFS%）

  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.

  1 year

Secondary Outcomes (3)

• Disease Free Survival (DFS)

  1 year

• Overall Survival (OS)

  1 year

• Tumor Recurrence Rate (TRR)

  1 year

Study Arms (1)

PANK-003 cell injection combined with standard postoperative adjuvant chemotherapy

EXPERIMENTAL

Drug: PANK-003 cell injection combined with standard postoperative adjuvant chemotherapy

Interventions

PANK-003 cell injection combined with standard postoperative adjuvant chemotherapy DRUG

PANK-003 cell injection combined with standard postoperative adjuvant chemotherapy

PANK-003 cell injection combined with standard postoperative adjuvant chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily participate in the clinical trial; fully understand and be informed about this study and sign the informed consent form;
• At the time of screening, the age should be between 18 and 75 years old (inclusive), regardless of gender;
• At the time of enrollment, the expected survival time is more than 6 Months;
• The Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1;
• 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 = \[(140 - age) × body weight (kg) × 0.85\] / \[0.818 × creatinine (μmol/L)\]).
• 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;
• Investigator-confirmed eligibility for study enrollment.

You may not qualify if:

• NSCLC patients who have received neoadjuvant therapy;
• Pregnant or lactating women;
• 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;
• 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(+);
• Received investigational drugs or other cell-based immunotherapy within 28 days before screening;
• Administration of live/attenuated vaccines within 4 weeks prior to NK cell infusion;

Sponsors & Collaborators

• Shenzhen Celconta Life Science Co., Ltd.: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Shuanghu Yuan

CONTACT

0551-65897870; yuanshuanghu@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2025
• First Posted: June 29, 2025
• Study Start: July 8, 2025
• Primary Completion (Estimated): July 8, 2028
• Study Completion (Estimated): June 18, 2029
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share