NSCLCPhase 2NCT05882513
Serplulimab Combined With Chemotherapy in Patients With Resectable Non-small-cell Lung Cancer
A Phase 2 study testing Serplulimab and neoadjuvant therapy, surgical resection of lung cancer and Tumour will be Collected from participant. Fate of sample is Destruction after use in people with NSCLC and Neoadjuvant Therapy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
China with high incidence of non-small cell lung cancer. In the past few decades, surgery, radiotherapy, chemotherapy and other treatments were continuously improved, however, the mortality of lung cancer patients was not significantly decreased. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC, Neoadjuvant Therapy
- What is being tested?
- Serplulimab and neoadjuvant therapy, surgical resection of lung cancer and Tumour will be Collected from participant. Fate of sample is Destruction after use
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 16 May 2023to 31 Dec 2030
- 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
- signed informed consent;
- patients age 18 to 75 years old
- primary resectable, histologically confirmed non small cell lung cancer;
- non small cell lung cancer the clinical stage was IIA-IIIB (no N3 patient) (according to AJCC TNM stage, 8th edition).
- ECOG PS 0-1.
- the diseases could be resectable assessed by thoracic oncologist
Who cannot join
- with significant cardiovascular disease;
- current treatment with anti-viral therapy or HBV;
- Female patients who are pregnant or lactating;
- history of malignancy within 5 years prior to screening;
- active or history of autoimmune disease or immune deficiency;
- signs of distant metastases.
Trial locations and contacts
1 site in 1 country.
China1 site
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, China, 310009
About this study
Official title: A Prospective, Single-arm, Single-center, Exploratory Study of the Safety and Efficacy of Serplulimab Combined With Chemotherapy in Patients With Resectable Non-small-cell Lung Cancer
China with high incidence of non-small cell lung cancer. In the past few decades, surgery, radiotherapy, chemotherapy and other treatments were continuously improved, however, the mortality of lung cancer patients was not significantly decreased. For patients with locally advanced lung cancer, direct surgery is not effective. It is difficult to achieve radical resection by surgery merely, and even if many patients receive surgery, they may eventually have tumor recurrence and poor survival rate. Therefore, it is necessary to explore effective perioperative neoadjuvant treatment to reduce the risk of postoperative recurrence and improve the postoperative survival rate of patients. According to the reports, PD-1/ PD-L1 immunocheckpoint inhibitor may become a new method for the treatment of lung cancer. Preliminary clinical results showed that immunotherapy combined with chemoradiotherapy provided a synergies antitumor effect. Multiple clinical results showed that serplulimab provided higher overall response rate for advanced lung cancer. However, in patients with locally advanced lung cancer, the efficacy of serplulimab combined with chemotherapy for sequential radical surgery is still unclear. The purpose of this study is to observe and evaluate the efficacy and safety of serplulimab combined with chemotherapy in the neoadjuvant therapy of resectable non-small cell lung cancer.
- Conditions
- NSCLC, Neoadjuvant Therapy
- Being tested
- Serplulimab and neoadjuvant therapy, surgical resection of lung cancer, Tumour will be Collected from participant. Fate of sample is Destruction after use
- Keywords
- serplulimab, Non small cell lung cancer, Neoadjuvant Therapy
- 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.
Serplulimab and neoadjuvant therapyDrug
Also called Serplulimab
Squamous cell carcinoma: Serplulimab: 4.5mg/kg, i.v, day1; albumin paclitaxel 260mg/m2, day1; carboplatin AUC=5, i.v, day1.
Non-squamous cell carcinoma: Serplulimab: 4.5mg/kg, i.v, day1 ; pemetrexed 500mg/m2, day1 ; carboplatin AUC=5, i.v, day1.
surgical resection of lung cancerProcedure or surgery
Also called Surgery
radical resection of lung cancer
Tumour will be Collected from participant. Fate of sample is Destruction after useOther
Tumour sample will be collected after surgery
| Study group | Role | What they receive |
|---|---|---|
| Lung cancer group | Experimental | Squamous cell carcinoma: Serplulimab: 4.5mg/kg, i.v, day1; albumin paclitaxel 260mg/m2, day1; carboplatin AUC=5, i.v, day1.
Non-squamous cell carcinoma: Serplulimab: 4.5mg/kg, i.v, day1 ; pemetrexed 500mg/m2, day1 ; carboplatin AUC=5, i.v, day1.
Preoperative neoadjuvant therapy for 3 cycles, one cycle every 21 days. Surgical resection of lung cancer will be arranged about 4-8 weeks after the last cycle of neoadjuvant therapy. Receives: Drug: Serplulimab and neoadjuvant therapy; Procedure: surgical resection of lung cancer; Other: Tumour will be Collected from participant. Fate of sample is Destruction after use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (PCR)
No residual invasive tumor cells were found in the pathological examination of resected specimens,including the primary tumor and lymph nodes.
Measured: 1 month after surgery
Secondary outcomes (6)
Major Pathological Response (MPR)
In the pathological examination of resected specimens, the proportion of residual tumor cells was less than 10%.
Measured: 1 month after surgery
Objective Response Rate (ORR)
The proportion of subjects with imaging PR or CR assessed according to RECIST 1.1 criteria
Measured: before surgery
2-year and 5-year overall survival
The proportion of all study cases in which no death from any cause occurred within 2 years and 5 years after enrolled
Measured: 2-year and 5-year after enrolled
Incidence of Treatment-related Adverse Events
Incidence of Treatment-related Adverse Events as Assessed by CTCAE v5.0
Measured: 1 month after surgery
R0 resection rate
The pathological results will showed that the incision margin was negative and no residual cancer cells were found under the microscope
Measured: 1 month after surgery
The changes in the tumor tissue sample among non-PCR (NPCR) and PCR patients
By using mass spectrometry (CyTOF) and single-cell analysis, we comprehensively characterized the immune landscape in the tumor sample of patients after anti-PD-1 immunotherapy, aiming to explore the immune subsets correlated with neoadjuvant immunotherapy response.
Measured: 3 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start16 May 2023
- Primary completion31 Dec 2025
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- 36 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weilin Wang, Study chair, 2nd Affiliated Hospital, School of Medicine, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05882513
- Sponsor's protocol ID
- 2023-0485
- Status last verified
- Nov 2025
- First submitted
- 22 May 2023
- Last updated
- 24 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Single-center, Exploratory Study of the Safety and Efficacy of Serplulimab Combined With Chemotherapy in Patients With Resectable Non-small-cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05882513
- Acronym / sponsor ID
- 2023-0485
- Conditions
- NSCLC, Neoadjuvant Therapy
- Keywords
- serplulimab, Non small cell lung cancer, Neoadjuvant Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 16 May 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 31 May 2023 (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.
China with high incidence of non-small cell lung cancer. In the past few decades, surgery, radiotherapy, chemotherapy and other treatments were continuously improved, however, the mortality of lung cancer patients was not significantly decreased. For patients with locally advanced lung cancer, direct surgery is not effective. It is difficult to achieve radical resection by surgery merely, and even if many patients receive surgery, they may eventually have tumor recurrence and poor survival rate. Therefore, it is necessary to explore effective perioperative neoadjuvant treatment to reduce the risk of postoperative recurrence and improve the postoperative survival rate of patients. According to the reports, PD-1/ PD-L1 immunocheckpoint inhibitor may become a new method for the treatment of lung cancer. Preliminary clinical results showed that immunotherapy combined with chemoradiotherapy provided a synergies antitumor effect. Multiple clinical results showed that serplulimab provided higher overall response rate for advanced lung cancer. However, in patients with locally advanced lung cancer, the efficacy of serplulimab combined with chemotherapy for sequential radical surgery is still unclear. The purpose of this study is to observe and evaluate the efficacy and safety of serplulimab combined with chemotherapy in the neoadjuvant therapy of resectable non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung cancer group | Experimental | Drug: Serplulimab and neoadjuvant therapy, Procedure: surgical resection of lung cancer, Other: Tumour will be Collected from participant. Fate of sample is Destruction after useSquamous cell carcinoma: Serplulimab: 4.5mg/kg, i.v, day1; albumin paclitaxel 260mg/m2, day1; carboplatin AUC=5, i.v, day1. Non-squamous cell carcinoma: Serplulimab: 4.5mg/kg, i.v, day1 ; pemetrexed 500mg/m2, day1 ; carboplatin AUC=5, i.v, day1. Preoperative neoadjuvant therapy for 3 cycles, one cycle every 21 days. Surgical resection of lung cancer will be arranged about 4-8 weeks after the last cycle of neoadjuvant therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- signed informed consent;
- patients age 18 to 75 years old
- primary resectable, histologically confirmed non small cell lung cancer;
- non small cell lung cancer the clinical stage was IIA-IIIB (no N3 patient) (according to AJCC TNM stage, 8th edition).
- ECOG PS 0-1.
Key exclusion criteria (6 listed)
- with significant cardiovascular disease;
- current treatment with anti-viral therapy or HBV;
- Female patients who are pregnant or lactating;
- history of malignancy within 5 years prior to screening;
- active or history of autoimmune disease or immune deficiency;
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 |
|---|---|---|
| Serplulimab and neoadjuvant therapyAlso: SerplulimabSquamous cell carcinoma: Serplulimab: 4.5mg/kg, i.v, day1; albumin paclitaxel 260mg/m2, day1; carboplatin AUC=5, i.v, day1. Non-squamous cell carcinoma: Serplulimab: 4.5mg/kg, i.v, day1 ; pemetrexed 500mg/m2, day1 ; carboplatin AUC=5, i.v, day1. | Drug | Lung cancer group |
| surgical resection of lung cancerAlso: Surgeryradical resection of lung cancer | Procedure or surgery | Lung cancer group |
| Tumour will be Collected from participant. Fate of sample is Destruction after useTumour sample will be collected after surgery | Other | Lung cancer group |
Primary outcome
Pathological Complete Response (PCR)
Time frame: 1 month after surgery
No residual invasive tumor cells were found in the pathological examination of resected specimens,including the primary tumor and lymph nodes.
6 secondary outcomes
Major Pathological Response (MPR)
Time frame: 1 month after surgery
Objective Response Rate (ORR)
Time frame: before surgery
2-year and 5-year overall survival
Time frame: 2-year and 5-year after enrolled
Incidence of Treatment-related Adverse Events
Time frame: 1 month after surgery
R0 resection rate
Time frame: 1 month after surgery
The changes in the tumor tissue sample among non-PCR (NPCR) and PCR patients
Time frame: 3 month after surgery
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 24 Apr 2026.
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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. This study is not recruiting at the moment.
Weilin Wang study chair
2nd Affiliated Hospital, School of Medicine, Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Serplulimab and neoadjuvant therapy, surgical resection of lung cancer and Tumour will be Collected from participant. Fate of sample is Destruction after use in people with NSCLC and Neoadjuvant Therapy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 6 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (PCR) (time frame: 1 month after surgery). 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 24 Apr 2026.