Resectable Stage II-IIIa NSCLCPhase 3ECTOP-1030NCT07554846
Comparison of Perioperative Immunotherapy, Adjuvant Immunotherapy or Neoadjuvant Immunotherapy for Resectable Stage II-IIIA NSCLC
A Phase 3 study testing Peroperative immunotherapy, Neoadjuvant immunotherapy and Adjuvant immunotherapy in people with Resectable Stage II-IIIa NSCLC, run by Fudan University at 1 site in China.
Trial summary
This is a randomized, open-label, multi-center Phase III clinical study aimed at head-to-head evaluating the clinical efficacy of three immunotherapy strategies, namely perioperative immunotherapy, neoadjuvant immunotherapy, and adjuvant immunotherapy using Toripalimab, in patients with resectable stage II-IIIA… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Resectable Stage II-IIIa NSCLC
- What is being tested?
- Peroperative immunotherapy, Neoadjuvant immunotherapy and Adjuvant immunotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 759 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 1 May 2032
- Phase
- Phase 3
- 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
- Aged 18-75, of either gender;
- Subjects with resectable stage II-IIIA non-small cell lung cancer (according to the AJCC 8th edition), without EGFR/ALK sensitive mutations, confirmed by histology or pathology;
- ECOG PS score of 0-1;
- There are measurable lesions according to RECIST 1.1;
- Expected survival duration ≥ 3 months;
- Main organ functions are normal (14 days before enrollment)
- According to the surgeon's assessment, the total lung function is capable of withstanding the proposed lung resection surgery;
Who cannot join
- Individuals known to be allergic to recombinant humanized anti-PD-1 monoclonal antibody drugs and their components;
- Currently participating in and receiving other research treatments;
- Previously received systemic treatment for resectable stage II-III non-small cell lung cancer, including systemic chemotherapy, targeted therapy, immunotherapy, etc;
- Patients with active tuberculosis (TB) who are currently undergoing anti-tuberculosis treatment or have received such treatment within the previous 1 year prior to screening;
- Uncontrollable or symptomatic hypercalcemia (>1.5 mmol/L calcium ion or calcium >12 mg/dL or corrected serum calcium >ULN);
- Clinically, there is uncontrolled active infection, including but not limited to acute pneumonia;
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- Uncontrollable severe epileptic seizures or superior vena cava syndrome;
- Previously or currently suffering from other malignant tumors (excluding non-melanoma basal cell carcinoma or squamous cell carcinoma of the skin, breast/cervical carcinoma in situ, superficial bladder cancer, and other carcinoma in situ that have undergone radical treatment with no evidence of disease recurrence);
- Patients with interstitial pneumonia, history of idiopathic pulmonary fibrosis, organizing pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia, idiopathic pneumonia, evidence of active pneumonia found during chest CT scan screening, or other moderate to severe pulmonary diseases that seriously affect lung function;
- Known human immunodeficiency virus (HIV) infection (known HIV antibody positive);
- Having severe cardiovascular diseases, such as New York Heart Association (NYHA) class 2 or above heart failure, unstable angina pectoris, unstable arrhythmia, myocardial infarction or cerebrovascular accident occurring within 6 months before enrollment;
- Within 2 years prior to the commencement of the study, having received systemic immunosuppressive medications (i.e., using corticosteroids or immunosuppressive drugs) due to any active autoimmune disease;
- Subjects who received live virus vaccine within 4 weeks before the study began;
- Patients who have previously received allogeneic stem cell or solid organ transplantation;
- Pregnant or lactating women, or women who may become pregnant, who test positive for pregnancy before their first medication, or patients who are capable of bearing children but are unwilling to accept contraceptive measures, or whose sexual partners are unwilling to accept contraceptive measures;
- Researchers believe that factors such as psychiatric or substance abuse history, inability to benefit from the clinical study, or conditions that affect patients' ability to sign informed consent forms (such as drug addiction and substance abuse), or any other clinically significant diseases or conditions that make patients unsuitable for participation in this clinical study (including but not limited to: abnormal laboratory results, clinically active diverticulitis, intra-abdominal abscess, intestinal obstruction, and peritoneal metastatic cancer) can affect study compliance.
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, 200032
Chaoqiang Deng, 021-64175590, fdudengcq@163.com
About this study
Official title: A Randomized, Open-label, Multicenter Phase III Clinical Trial Comparing Perioperative Immunotherapy to Adjuvant Immunotherapy or Neoadjuvant Immunotherapy With Toripalimab in Resectable Stage II-IIIA Non-small Cell Lung Cancer (ECTOP-1030)
This is a randomized, open-label, multi-center Phase III clinical study aimed at head-to-head evaluating the clinical efficacy of three immunotherapy strategies, namely perioperative immunotherapy, neoadjuvant immunotherapy, and adjuvant immunotherapy using Toripalimab, in patients with resectable stage II-IIIA non-small cell lung cancer (NSCLC) without EGFR/ALK sensitive mutations. This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1030.
- Conditions
- Resectable Stage II-IIIa NSCLC
- Being tested
- Peroperative immunotherapy, Neoadjuvant immunotherapy, Adjuvant immunotherapy
- 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.
Peroperative immunotherapyDrug
Neoadjuvant phase: Toripalimab injection [240 mg, administered on Day 1, Q3W (once every 3 weeks)] + pemetrexed injection [500 mg/m2, administered on Day 1, Q3W] + carboplatin injection (AUC=5, administered on Day 1, Q3W) or cisplatin injection (75 mg/m2, administered on Day 1, Q3W) for 3 cycles; Adjuvant phase: Toripalimab injection [240 mg, administered on Day 1, Q3W (once every 3 weeks)] + pemetrexed injection [500 mg/m2, administered on Day 1, Q3W] + carboplatin injection (AUC=5, administered on Day 1, Q3W) or cisplatin injection (75 mg/m2, administered on Day 1, Q3W) for 1 cycles; Maintenanse phase: Toripalimab injection [240 mg, administered on Day 1, Q3W (once every 3 weeks)] for 13 cycles.
Neoadjuvant immunotherapyDrug
Neoadjuvant phase: Toripalimab injection [240 mg, administered on Day 1, Q3W (once every 3 weeks)] + pemetrexed injection [500 mg/m2, administered on Day 1, Q3W] + carboplatin injection (AUC=5, administered on Day 1, Q3W) or cisplatin injection (75 mg/m2, administered on Day 1, Q3W) for 3 cycles;
Adjuvant immunotherapyDrug
Adjuvant phase: Pemetrexed injection [500 mg/m2, administered on Day 1, Q3W] + carboplatin injection (AUC=5, administered on Day 1, Q3W) or cisplatin injection (75 mg/m2, administered on Day 1, Q3W) for 1-4 cycles; Maintenanse phase: Toripalimab injection [240 mg, administered on Day 1, Q3W (once every 3 weeks)] for 17 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Perioperative immunotherapy | Experimental | After randomization, patients will receive neoadjuvant treatment with three cycles of Toripalimab combined with platinum-based doublet chemotherapy, one cycle per 3 weeks and the drug administered on the first day of each cycle. Radical surgery will be performed within 4-6 weeks after completing the three cycles of neoadjuvant treatment. Subjects who have undergone radical surgery will receive one cycle of adjuvant treatment with Toripalimab combined with platinum-based doublet chemotherapy post-surgery, followed by 13 cycles of maintenance treatment with Toripalimab, one cycle per 3 weeks and the drug administered on the first day of each cycle Receives: Drug: Peroperative immunotherapy |
| Neoadjuvant immunotherapy | Active comparator | After randomization, patients will receive neoadjuvant treatment with three cycles of Toripalimab combined with platinum-based doublet chemotherapy, one cycle per 3 weeks and the drug administered on the first day of each cycle. Radical surgery will be performed within 4-6 weeks after completing the three cycles of neoadjuvant treatment. Subjects who have undergone radical surgery will selectively receive adjuvant chemotherapy with or without radiation therapy post-surgery Receives: Drug: Neoadjuvant immunotherapy |
| Adjuvant immunotherapy | Active comparator | After randomization, subjects will undergo radical surgery. Those who complete the radical surgery will receive adjuvant platinum-based doublet chemotherapy for 1-4 cycles after surgery, followed by 17 cycles of maintenance therapy with Toripalimab, administered every 3 weeks on first day of each cycle. Receives: Drug: Adjuvant immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year events-free survival (EFS) rate
It is defined as the percentage of the total number of individuals in the analysis dataset who, from randomization to the first recorded event, die due to disease progression leading to inoperability, distant metastatic lesions, local recurrence, or any other reason within 3 years.
Measured: From randomization up to 3 years after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start1 May 2026
- Primary completion1 May 2030 (estimated)
- Study completion1 May 2032 (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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 759 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
- NCT07554846
- Sponsor's protocol ID
- NSCLC-IIT-JS001-P04
- Acronym
- ECTOP-1030
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 10 Sep 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 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multicenter Phase III Clinical Trial Comparing Perioperative Immunotherapy to Adjuvant Immunotherapy or Neoadjuvant Immunotherapy With Toripalimab in Resectable Stage II-IIIA Non-small Cell Lung Cancer (ECTOP-1030)
- ClinicalTrials.gov ID
- NCT07554846
- Acronym / sponsor ID
- ECTOP-1030 / NSCLC-IIT-JS001-P04
- Conditions
- Resectable Stage II-IIIa NSCLC
- Keywords
- lung cancer, immunotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 759 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 May 2030 (estimated)
- Study completion
- 1 May 2032 (estimated)
- First posted
- 28 Apr 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 is a randomized, open-label, multi-center Phase III clinical study aimed at head-to-head evaluating the clinical efficacy of three immunotherapy strategies, namely perioperative immunotherapy, neoadjuvant immunotherapy, and adjuvant immunotherapy using Toripalimab, in patients with resectable stage II-IIIA non-small cell lung cancer (NSCLC) without EGFR/ALK sensitive mutations. This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1030.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Perioperative immunotherapy | Experimental | Drug: Peroperative immunotherapyAfter randomization, patients will receive neoadjuvant treatment with three cycles of Toripalimab combined with platinum-based doublet chemotherapy, one cycle per 3 weeks and the drug administered on the first day of each cycle. Radical surgery will be performed within 4-6 weeks after completing the three cycles of neoadjuvant treatment. Subjects who have undergone radical surgery will receive one cycle of adjuvant treatment with Toripalimab combined with platinum-based doublet chemotherapy post-surgery, followed by 13 cycles of maintenance treatment with Toripalimab, one cycle per 3 weeks and the drug administered on the first day of each cycle |
| Neoadjuvant immunotherapy | Active comparator | Drug: Neoadjuvant immunotherapyAfter randomization, patients will receive neoadjuvant treatment with three cycles of Toripalimab combined with platinum-based doublet chemotherapy, one cycle per 3 weeks and the drug administered on the first day of each cycle. Radical surgery will be performed within 4-6 weeks after completing the three cycles of neoadjuvant treatment. Subjects who have undergone radical surgery will selectively receive adjuvant chemotherapy with or without radiation therapy post-surgery |
| Adjuvant immunotherapy | Active comparator | Drug: Adjuvant immunotherapyAfter randomization, subjects will undergo radical surgery. Those who complete the radical surgery will receive adjuvant platinum-based doublet chemotherapy for 1-4 cycles after surgery, followed by 17 cycles of maintenance therapy with Toripalimab, administered every 3 weeks on first day of each cycle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18-75, of either gender;
- Subjects with resectable stage II-IIIA non-small cell lung cancer (according to the AJCC 8th edition), without EGFR/ALK sensitive mutations, confirmed by histology or pathology;
- ECOG PS score of 0-1;
- There are measurable lesions according to RECIST 1.1;
- Expected survival duration ≥ 3 months;
Key exclusion criteria (16 listed)
- Individuals known to be allergic to recombinant humanized anti-PD-1 monoclonal antibody drugs and their components;
- Currently participating in and receiving other research treatments;
- Previously received systemic treatment for resectable stage II-III non-small cell lung cancer, including systemic chemotherapy, targeted therapy, immunotherapy, etc;
- Patients with active tuberculosis (TB) who are currently undergoing anti-tuberculosis treatment or have received such treatment within the previous 1 year prior to screening;
- Uncontrollable or symptomatic hypercalcemia (>1.5 mmol/L calcium ion or calcium >12 mg/dL or corrected serum calcium >ULN);
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 |
|---|---|---|
| Peroperative immunotherapyNeoadjuvant phase: Toripalimab injection [240 mg, administered on Day 1, Q3W (once every 3 weeks)] + pemetrexed injection [500 mg/m2, administered on Day 1, Q3W] + carboplatin injection (AUC=5, administered on Day 1, Q3W) or cisplatin injection (75 mg/m2, administered on Day 1, Q3W) for 3 cycles; Adjuvant phase: Toripalimab injection [240 mg, administered on Day 1, Q3W (once every 3 weeks)] + pemetrexed injection [500 mg/m2, administered on Day 1, Q3W] + carboplatin injection (AUC=5, administered on Day 1, Q3W) or cisplatin injection (75 mg/m2, administered on Day 1, Q3W) for 1 cycles; Maintenanse phase: Toripalimab injection [240 mg, administered on Day 1, Q3W (once every 3 weeks)] for 13 cycles. | Drug | Perioperative immunotherapy |
| Neoadjuvant immunotherapyNeoadjuvant phase: Toripalimab injection [240 mg, administered on Day 1, Q3W (once every 3 weeks)] + pemetrexed injection [500 mg/m2, administered on Day 1, Q3W] + carboplatin injection (AUC=5, administered on Day 1, Q3W) or cisplatin injection (75 mg/m2, administered on Day 1, Q3W) for 3 cycles; | Drug | Neoadjuvant immunotherapy |
| Adjuvant immunotherapyAdjuvant phase: Pemetrexed injection [500 mg/m2, administered on Day 1, Q3W] + carboplatin injection (AUC=5, administered on Day 1, Q3W) or cisplatin injection (75 mg/m2, administered on Day 1, Q3W) for 1-4 cycles; Maintenanse phase: Toripalimab injection [240 mg, administered on Day 1, Q3W (once every 3 weeks)] for 17 cycles. | Drug | Adjuvant immunotherapy |
Primary outcome
3-year events-free survival (EFS) rate
Time frame: From randomization up to 3 years after randomization
It is defined as the percentage of the total number of individuals in the analysis dataset who, from randomization to the first recorded event, die due to disease progression leading to inoperability, distant metastatic lesions, local recurrence, or any other reason within 3 years.
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 Sep 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 3 study testing Peroperative immunotherapy, Neoadjuvant immunotherapy and Adjuvant immunotherapy in people with Resectable Stage II-IIIa 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 7 inclusion and 16 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 Sep 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
3-year events-free survival (EFS) rate (time frame: From randomization up to 3 years 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 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.