Resectable Stage II-IIIa Squamous NSCLCPhase 2ECTOP-1036NCT07398937
Comparison of Serplulimab Versus Nivolumab in Neoadjuvant Therapy for Resectable Stage II-IIIA Squamous NSCLC
A Phase 2 study testing Serplulimab + chemotherapy and Nivolumab + chemotherapy in people with Resectable Stage II-IIIa Squamous NSCLC, run by Fudan University at 1 site in China.
Trial summary
This trial is a randomized, controlled, multicenter, open-label study, planning to enroll 116 subjects with resectable stage II-IIIa squamous NSCLC confirmed by histopathology or cytology, aiming to evaluate the efficacy and safety of serplulimab compared to nivolumab combined with chemotherapy in neoadjuvant therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Resectable Stage II-IIIa Squamous NSCLC
- What is being tested?
- Serplulimab + chemotherapy and Nivolumab + chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- 5 Feb 2026to 31 Dec 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
- Age ≥ 18 years and ≤ 75 years at time of study entry.
- The International Federation of Gynecology and Obstetrics (FIGO) 2018 Stages II-IIIA squamous non-small cell lung cancer confirmed by histopathology or cytology.
- The patient with stage II-IIIA squamous non-small cell lung cancer confirmed by histopathology or cytology;
- Able to tolerate complete lung cancer resection;
- WHO/ECOG performance status of 0 or 1.
Who cannot join
- Other pathological histological types of non-small cell lung cancer subjects, including adenocarcinoma subjects, squamous-adenocarcinoma mixed cancer subjects, and NSCLC containing components of small cell lung cancer and neuroendocrine carcinoma.
- EGFR sensitivity mutation or ALK, ROS1 gene rearrangement;
- Known severe allergy to any components of carboplatin/albumin paclitaxel and other drugs;
- Central nervous system (CNS) or leptomeningeal metastases confirmed by imaging or pathology
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Fangqiu Fu, 021-64175590, fufangqiu12@163.com
About this study
Official title: A Randomized, Open-label, Multicenter Phase II Clinical Trial Evaluating the Efficacy and Safety of Serplulimab Combined With Chemotherapy Versus Nivolumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage II-IIIa Squamous NSCLC.
This trial is a randomized, controlled, multicenter, open-label study, planning to enroll 116 subjects with resectable stage II-IIIa squamous NSCLC confirmed by histopathology or cytology, aiming to evaluate the efficacy and safety of serplulimab compared to nivolumab combined with chemotherapy in neoadjuvant therapy. This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1036.
- Conditions
- Resectable Stage II-IIIa Squamous NSCLC
- Being tested
- Serplulimab + chemotherapy, Nivolumab + chemotherapy
- Keywords
- lung cancer, immunotherapy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serplulimab + chemotherapyDrug
Serplulimab injection [300 mg, administered on Day 1, Q3W (once every 3 weeks)] + paclitaxel (albumin-bound) for injection [260 mg/m2, highest dose Not More Than 400 mg, administered on Day 1, Q3W] + carboplatin injection (AUC=5, highest dose Not More Than 750 mg, administered on Day 1, Q3W) for 2-3 cycles
Nivolumab + chemotherapyDrug
Nivolumab [360 mg, administered on Day 1, Q3W (once every 3 weeks)] + paclitaxel (albumin-bound) for injection [260 mg/m2, highest dose Not More Than 400 mg, administered on Day 1, Q3W] + carboplatin injection (AUC=5, highest dose Not More Than 750 mg, administered on Day 1, Q3W) for 2-3 cycles;
| Study group | Role | What they receive |
|---|---|---|
| Serplulimab + chemotherapy | Experimental | Serplulimab injection [300 mg, administered on Day 1, Q3W (once every 3 weeks)] + paclitaxel (albumin-bound) for injection [260 mg/m2, highest dose Not More Than 400 mg, administered on Day 1, Q3W] + carboplatin injection (AUC=5, highest dose Not More Than 750 mg, administered on Day 1, Q3W) for 2-3 cycles; Receives: Drug: Serplulimab + chemotherapy |
| Nivolumab + chemotherapy | Active comparator | Nivolumab [360 mg, administered on Day 1, Q3W (once every 3 weeks)] + paclitaxel (albumin-bound) for injection [260 mg/m2, highest dose Not More Than 400 mg, administered on Day 1, Q3W] + carboplatin injection (AUC=5, highest dose Not More Than 750 mg, administered on Day 1, Q3W) for 2-3 cycles; Receives: Drug: Nivolumab + chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete remission (PCR) rate
Pathologic complete response (pCR) rate is defined as the number of randomized participants with absence of residual tumor in lung and lymph nodes as evaluated by investigator.
Measured: From randomization up to a median of 30 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start5 Feb 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Stage II-IIIa Squamous NSCLCStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
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
- NCT07398937
- Sponsor's protocol ID
- HLX10IIT314
- Acronym
- ECTOP-1036
- Status last verified
- Jan 2026
- First submitted
- 3 Feb 2026
- Last updated
- 10 Feb 2026
- Results posted
- 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 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multicenter Phase II Clinical Trial Evaluating the Efficacy and Safety of Serplulimab Combined With Chemotherapy Versus Nivolumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage II-IIIa Squamous NSCLC.
- ClinicalTrials.gov ID
- NCT07398937
- Acronym / sponsor ID
- ECTOP-1036 / HLX10IIT314
- Conditions
- Resectable Stage II-IIIa Squamous NSCLC
- Keywords
- lung cancer, immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 5 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 10 Feb 2026 (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 trial is a randomized, controlled, multicenter, open-label study, planning to enroll 116 subjects with resectable stage II-IIIa squamous NSCLC confirmed by histopathology or cytology, aiming to evaluate the efficacy and safety of serplulimab compared to nivolumab combined with chemotherapy in neoadjuvant therapy. This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1036.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serplulimab + chemotherapy | Experimental | Drug: Serplulimab + chemotherapySerplulimab injection [300 mg, administered on Day 1, Q3W (once every 3 weeks)] + paclitaxel (albumin-bound) for injection [260 mg/m2, highest dose Not More Than 400 mg, administered on Day 1, Q3W] + carboplatin injection (AUC=5, highest dose Not More Than 750 mg, administered on Day 1, Q3W) for 2-3 cycles; |
| Nivolumab + chemotherapy | Active comparator | Drug: Nivolumab + chemotherapyNivolumab [360 mg, administered on Day 1, Q3W (once every 3 weeks)] + paclitaxel (albumin-bound) for injection [260 mg/m2, highest dose Not More Than 400 mg, administered on Day 1, Q3W] + carboplatin injection (AUC=5, highest dose Not More Than 750 mg, administered on Day 1, Q3W) for 2-3 cycles; |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years and ≤ 75 years at time of study entry.
- The International Federation of Gynecology and Obstetrics (FIGO) 2018 Stages II-IIIA squamous non-small cell lung cancer confirmed by histopathology or cytology.
- The patient with stage II-IIIA squamous non-small cell lung cancer confirmed by histopathology or cytology;
- Able to tolerate complete lung cancer resection;
- WHO/ECOG performance status of 0 or 1.
Key exclusion criteria (4 listed)
- Other pathological histological types of non-small cell lung cancer subjects, including adenocarcinoma subjects, squamous-adenocarcinoma mixed cancer subjects, and NSCLC containing components of small cell lung cancer and neuroendocrine carcinoma.
- EGFR sensitivity mutation or ALK, ROS1 gene rearrangement;
- Known severe allergy to any components of carboplatin/albumin paclitaxel and other drugs;
- Central nervous system (CNS) or leptomeningeal metastases confirmed by imaging or pathology
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 + chemotherapySerplulimab injection [300 mg, administered on Day 1, Q3W (once every 3 weeks)] + paclitaxel (albumin-bound) for injection [260 mg/m2, highest dose Not More Than 400 mg, administered on Day 1, Q3W] + carboplatin injection (AUC=5, highest dose Not More Than 750 mg, administered on Day 1, Q3W) for 2-3 cycles | Drug | Serplulimab + chemotherapy |
| Nivolumab + chemotherapyNivolumab [360 mg, administered on Day 1, Q3W (once every 3 weeks)] + paclitaxel (albumin-bound) for injection [260 mg/m2, highest dose Not More Than 400 mg, administered on Day 1, Q3W] + carboplatin injection (AUC=5, highest dose Not More Than 750 mg, administered on Day 1, Q3W) for 2-3 cycles; | Drug | Nivolumab + chemotherapy |
Primary outcome
Pathological complete remission (PCR) rate
Time frame: From randomization up to a median of 30 months after randomization
Pathologic complete response (pCR) rate is defined as the number of randomized participants with absence of residual tumor in lung and lymph nodes as evaluated by investigator.
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 10 Feb 2026.
- 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.
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 + chemotherapy and Nivolumab + chemotherapy in people with Resectable Stage II-IIIa Squamous NSCLC, 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 10 Feb 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete remission (PCR) rate (time frame: From randomization up to a median of 30 months after randomization). 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 10 Feb 2026.