Stage IIIA Non-small Cell Lung CancerPhase 2NCT07043907
PANK-003 Cell Injection Combined With Standard Adjuvant Chemotherapy After Surgery in Patients With Stage IIIA NSCLC
A Phase 2 study testing PANK-003 cell injection combined with standard postoperative adjuvant chemotherapy in people with Stage IIIA Non-small Cell Lung Cancer, run by Shenzhen Celconta Life Science Co., Ltd..
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stage IIIA Non-small Cell Lung Cancer
- What is being tested?
- PANK-003 cell injection combined with standard postoperative adjuvant chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- No sites listed yet
- Study dates
- 8 Jul 2025to 18 Jun 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- 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:
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- 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.
Who cannot join
- 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
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- 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;
- Medical conditions requiring systemic corticosteroid therapy or other immunosuppressive drug treatments during the study period as determined by the investigator;
- Hypersensitivity to:
- Any component of NK cell products (including serum albumin)
- Common emergency medications or anesthetics;
- 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;
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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
Read the 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.
- Conditions
- Stage IIIA Non-small Cell Lung Cancer
- Being tested
- PANK-003 cell injection combined with standard postoperative adjuvant chemotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PANK-003 cell injection combined with standard postoperative adjuvant chemotherapyDrug
PANK-003 cell injection combined with standard postoperative adjuvant chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| PANK-003 cell injection combined with standard postoperative adjuvant chemotherapy | Experimental | Not described Receives: Drug: PANK-003 cell injection combined with standard postoperative adjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs)
Incidence, severity and clinically significant abnormal laboratory findings of treatment related AEs.
Measured: 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.
Measured: 1 year
Secondary outcomes (3)
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.
Measured: 1 year
Overall Survival (OS)
Overall Survival (OS):The time from the date of first administration of PANK-003 cell injection to deathfrom any cause.
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start8 Jul 2025 (estimated)
- Primary completion8 Jul 2028 (estimated)
- Study completion18 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IIIA Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Celconta Life Science Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07043907
- Sponsor's protocol ID
- 2025-ETHICS COMMITTEE OPIN-038
- Status last verified
- Jun 2025
- First submitted
- 21 Jun 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07043907
- Acronym / sponsor ID
- 2025-ETHICS COMMITTEE OPIN-038
- Conditions
- Stage IIIA Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Shenzhen Celconta Life Science Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Jul 2025 (estimated)
- Primary completion
- 8 Jul 2028 (estimated)
- Study completion
- 18 Jun 2029 (estimated)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PANK-003 cell injection combined with standard postoperative adjuvant chemotherapy | Experimental | Drug: PANK-003 cell injection combined with standard postoperative adjuvant chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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;
- The Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1;
Key exclusion criteria (32 listed)
- NSCLC patients who have received neoadjuvant therapy;
- Pregnant or lactating women;
- History of other malignancies, except:
- Positive virology serology meeting any of:
- Received investigational drugs or other cell-based immunotherapy within 28 days before screening;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PANK-003 cell injection combined with standard postoperative adjuvant chemotherapyPANK-003 cell injection combined with standard postoperative adjuvant chemotherapy | Drug | PANK-003 cell injection combined with standard postoperative adjuvant chemotherapy |
Primary outcome
Incidence and severity of adverse events (AEs)
Time frame: 3 months
Incidence, severity and clinically significant abnormal laboratory findings of treatment related AEs.
Disease Free Surviva Percentage（DFS%）
Time frame: 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.
3 secondary outcomes
Disease Free Survival (DFS)
Time frame: 1 year
Overall Survival (OS)
Time frame: 1 year
Tumor Recurrence Rate (TRR)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PANK-003 cell injection combined with standard postoperative adjuvant chemotherapy in people with Stage IIIA Non-small Cell Lung Cancer, run by Shenzhen Celconta Life Science Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shuanghu Yuan (0551-65897870, yuanshuanghu@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs) (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.