Comparison of Perioperative Immunotherapy, Adjuvant Immunotherapy or Neoadjuvant Immunotherapy for Resectable Stage II-IIIA NSCLC (ECTOP-1030)

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 mutations. This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1030.

Study Overview

• Status: Not yet recruiting
• Conditions: Resectable Stage II-IIIa NSCLC
• Intervention / Treatment: Drug: Peroperative immunotherapy; Drug: Neoadjuvant immunotherapy; Drug: Adjuvant immunotherapy

• Study Type: Interventional
• Enrollment (Estimated): 759
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200032
    • Fudan University Shanghai Cancer Center
    • Contact: Chaoqiang Deng; Phone Number: 021-64175590; Email: fdudengcq@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged 18-75, of either gender;
2. Subjects with resectable stage II-IIIA non-small cell lung cancer (according to the AJCC 8th edition), EGFR wild type, and no ALK rearrangement, confirmed by histology or pathology;
3. ECOG PS score of 0-1;
4. There are measurable lesions according to RECIST 1.1;
5. Expected survival duration ≥ 3 months;
6. Main organ functions are normal (14 days before enrollment)
7. According to the surgeon's assessment, the total lung function is capable of withstanding the proposed lung resection surgery;

Exclusion Criteria:

1. Individuals known to be allergic to recombinant humanized anti-PD-1 monoclonal antibody drugs and their components;
2. Currently participating in and receiving other research treatments;
3. Previously received systemic treatment for resectable stage II-III non-small cell lung cancer, including systemic chemotherapy, targeted therapy, immunotherapy, etc;
4. 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;
5. Uncontrollable or symptomatic hypercalcemia (>1.5 mmol/L calcium ion or calcium >12 mg/dL or corrected serum calcium >ULN);
6. Clinically, there is uncontrolled active infection, including but not limited to acute pneumonia;
7. Uncontrollable severe epileptic seizures or superior vena cava syndrome;
8. 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);
9. 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;
10. Known human immunodeficiency virus (HIV) infection (known HIV antibody positive);
11. 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;
12. 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;
13. Subjects who received live virus vaccine within 4 weeks before the study began;
14. Patients who have previously received allogeneic stem cell or solid organ transplantation;
15. 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;
16. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Perioperative immunotherapy; 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	Drug: Peroperative immunotherapy; 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.
Active Comparator: Neoadjuvant immunotherapy; 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	Drug: Neoadjuvant immunotherapy; 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;
Active Comparator: Adjuvant immunotherapy; 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.	Drug: Adjuvant immunotherapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From randomization up to 3 years after randomization

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2032

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: April 21, 2026
• First Posted (Actual): April 28, 2026

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: immunotherapy; lung cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: NSCLC-IIT-JS001-P04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No