About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
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.;
At the time of enrollment, the expected survival time is more than 6 Months;
Disqualifiers
NSCLC patients who have received neoadjuvant therapy;
Pregnant or lactating women;
Cured non-melanoma skin cancer
Carcinoma in situ of the cervix
Trial design
Single group
Treatments tested in this trial
PANK-003 cell injection combined with standard postoperative adjuvant chemotherapy
DrugPANK-003 cell injection combined with standard postoperative adjuvant chemotherapy
Treatment groups
Trial outcomes
Primary outcomes
Incidence and severity of adverse events (AEs)
Incidence, severity and clinically significant abnormal laboratory findings of treatment related AEs.
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.
Secondary outcomes
Disease Free Survival (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.
Overall Survival (OS)
Overall Survival (OS):The time from the date of first administration of PANK-003 cell injection to deathfrom any cause.
Tumor Recurrence Rate (TRR)
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.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: