Non-small Cell Lung CancerPhase 2NCT05775796
Evaluate the Efficacy and Safety of Serplulimab Plus Chemotherapy in Neoadjuvant and Adjuvant Treatment of Resectable NSCLC (ECTOP-1013)
A Phase 2 study testing Serplulimab and Chemotherapy in people with Non-small Cell Lung Cancer and Stage II-IIIA, run by Fudan University at 1 site in China.
Trial summary
This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1013. The purpose of this neoadjuvant and adjuvant study is to evaluate the efficacy and safety of Serplulimab and chemotherapy in treating resectable Non-Small Cell Lung Cancer(NSCLC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer, Stage II-IIIA, Immunotherapy
- What is being tested?
- Serplulimab and Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2023to 1 Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue.
- Able and willing to give written informed consent and has signed the informed consent form (ICF), prior to performance of any trial activities.
- Eligible male and female subjects aged 18-75 years.
- Lung function capacity capable of tolerating the proposed lung surgery.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
- Available tissue of primary lung tumor.
Who cannot join
- Presence of locally advanced, inoperable or metastatic disease.
- Subjects with EGFR mutation or ALK、ROS1 gene rearrangement.
- Active, known or suspected autoimmune disease.
- Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors).
- Other protocol defined inclusion/exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
About this study
Official title: A Single-arm, Multicenter, and Phase II Clinical Study to Evaluate the Efficacy and Safety of Serplulimab Combined With Chemotherapy in Neoadjuvant and Adjuvant Treatment of Resectable Stage II-IIIA NSCLC
This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1013. The purpose of this neoadjuvant and adjuvant study is to evaluate the efficacy and safety of Serplulimab and chemotherapy in treating resectable Non-Small Cell Lung Cancer(NSCLC). The study also intended to explore the immune function of tumor-draining lymph nodes during immunotherapy.
- Being tested
- Serplulimab and 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.
Serplulimab and ChemotherapyDrug
Serplulimab+Paclitaxel+Cisplatin/Carboplatin Serplulimab+Pemetrexed+Cisplatin/Carboplatin
| Study group | Role | What they receive |
|---|---|---|
| Serplulimab plus platinum doublet chemotherapy | Experimental | Not described Receives: Drug: Serplulimab and Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Major Pathologic Response (MPR)
Major pathologic response (MPR) rate is defined as after neoadjuvant treatment, the percentage of residual tumor cells in the tumor bed ≤ 10%, regardless of the proportion of patients with residual tumor cells in lymph nodes
Measured: Up to 6 months
Secondary outcomes (5)
Rate of Pathologic Complete Response (pCR)
Proportion of patients without residual tumor cells in tumor bed and lymph nodes after neoadjuvant therapy
Measured: Up to 6 months
Rate of R0 resection
The complete resection rate is the proportion of patients with complete resection
Measured: Up to 6 months
Objective remission rate(ORR)
Objective response rate according to RECIST 1.1
Measured: Up to 6 months
Event-Free Survival (EFS)
Event-free survival (EFS) is defined as the length of time from enrollment to any of the following events: any progression of disease precluding surgery, progression or recurrence disease assessment per response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Patients who don't undergo surgery for reason other than progression will be considered to have an event at progression or death.
Measured: 2 years
Immune infiltrations in tumor-draining lymph nodes
Immune cell subtype infiltrations in tumor-draining lymph nodes by single-cell sequencing
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start15 Mar 2023
- Primary completion28 May 2024
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haiquan Chen, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05775796
- Sponsor's protocol ID
- HLX10IIT21
- Status last verified
- Sep 2025
- First submitted
- 7 Mar 2023
- Last updated
- 1 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fu F, Wu H, Deng C, Chen H, Huang Q, Yuan C, Ding X, Ye T, Zhou Y, Chen S, Sun Y, Zhang Y, Xiang J, Wang S, Li Y, Li B, Lu Y, Zhang Y, Hu H, Chen H. Simplified perioperative serplulimab and chemotherapy for resectable squamous NSCLC: a phase II trial with biomarker analysis. J Immunother Cancer. 2026 May 11;14(5):e014437. doi: 10.1136/jitc-2025-014437.
PubMed 42114951
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Multicenter, and Phase II Clinical Study to Evaluate the Efficacy and Safety of Serplulimab Combined With Chemotherapy in Neoadjuvant and Adjuvant Treatment of Resectable Stage II-IIIA NSCLC
- ClinicalTrials.gov ID
- NCT05775796
- Acronym / sponsor ID
- HLX10IIT21
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 28 May 2024 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 20 Mar 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.
This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1013. The purpose of this neoadjuvant and adjuvant study is to evaluate the efficacy and safety of Serplulimab and chemotherapy in treating resectable Non-Small Cell Lung Cancer(NSCLC). The study also intended to explore the immune function of tumor-draining lymph nodes during immunotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Serplulimab plus platinum doublet chemotherapy | Experimental | Drug: Serplulimab and Chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue.
- Able and willing to give written informed consent and has signed the informed consent form (ICF), prior to performance of any trial activities.
- Eligible male and female subjects aged 18-75 years.
- Lung function capacity capable of tolerating the proposed lung surgery.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
Key exclusion criteria (5 listed)
- Presence of locally advanced, inoperable or metastatic disease.
- Subjects with EGFR mutation or ALK、ROS1 gene rearrangement.
- Active, known or suspected autoimmune disease.
- Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors).
- Other protocol defined inclusion/exclusion criteria apply
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 ChemotherapySerplulimab+Paclitaxel+Cisplatin/Carboplatin Serplulimab+Pemetrexed+Cisplatin/Carboplatin | Drug | Serplulimab plus platinum doublet chemotherapy |
Primary outcome
Rate of Major Pathologic Response (MPR)
Time frame: Up to 6 months
Major pathologic response (MPR) rate is defined as after neoadjuvant treatment, the percentage of residual tumor cells in the tumor bed ≤ 10%, regardless of the proportion of patients with residual tumor cells in lymph nodes
5 secondary outcomes
Rate of Pathologic Complete Response (pCR)
Time frame: Up to 6 months
Rate of R0 resection
Time frame: Up to 6 months
Objective remission rate(ORR)
Time frame: Up to 6 months
Event-Free Survival (EFS)
Time frame: 2 years
Immune infiltrations in tumor-draining lymph nodes
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Derived from this study: PubMed 42114951Fu F, Wu H, Deng C, Chen H, Huang Q, Yuan C, Ding X, Ye T, Zhou Y, Chen S, Sun Y, Zhang Y, Xiang J, Wang S, Li Y, Li B, Lu Y, Zhang Y, Hu H, Chen H. Simplified perioperative serplulimab and chemotherapy for resectable squamous NSCLC: a phase II trial with biomarker analysis. J Immunother Cancer. 2026 May 11;14(5):e014437. doi: 10.1136/jitc-2025-014437.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Chemotherapy in people with Non-small Cell Lung Cancer and Stage II-IIIA, run by Fudan University 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 5 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: finished, as of the sponsor's last update on 1 Oct 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of Major Pathologic Response (MPR) (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05775796, which also lists 1 linked publication.
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 Oct 2025.