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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShenzhen Celconta Life Science Co., Ltd.

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

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

    Drug

    PANK-003 cell injection combined with standard postoperative adjuvant chemotherapy

Treatment groups

115 Participants
are divided into 1 treatment group
Group A: PANK-003 cell injection combined with standard postoperative adjuvant chemotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence and severity of adverse events (AEs)

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

Time frame
3 months
2

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.

Time frame
1 year

Secondary outcomes

1

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.

Time frame
1 year
2

Overall Survival (OS)

Overall Survival (OS):The time from the date of first administration of PANK-003 cell injection to deathfrom any cause.

Time frame
1 year
3

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.

Time frame
1 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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