Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 18 to 75

Compared immunotherapy timings in resectable stage II-IIIA NSCLC

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)

Run by Fudan University · NCT07554846 · Data updated 2026-11-12

In people with resectable stage II-IIIA non-small cell lung cancer, this study will test three timing approaches of the anti-PD-1 therapy toripalimab to see which works best when given around surgery.

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment759 (estimated)
SponsorFudan University
Academic / other
Drugs / interventionschemotherapy, immunotherapy, Toripalimab
Locations1 site (Shanghai)
StatusRecruiting
StartedMay 1, 2026
Main results expectedMay 1, 2030
Study endsMay 1, 2032
Registry record updatedSeptember 10, 2026
Trial IDNCT07554846 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18-75 with resectable stage II-IIIA NSCLC, EGFR/ALK wild-type, good performance status (ECOG 0-1), measurable disease, and adequate organ function who are planned for surgery.

Probably not a fit

Patients with incompatible mutations, poor performance status, active infections, prior systemic therapy for this cancer, or inability to undergo surgery may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, open-label Phase III trial conducted at multiple centers to compare perioperative, neoadjuvant, and adjuvant toripalimab in patients with resectable stage II-IIIA NSCLC without EGFR/ALK mutations. Eligible participants have good performance status, measurable disease, and adequate organ function, and are planned for surgical resection. The study uses RECIST 1.1 to define measurable lesions and evaluates safety and efficacy across the three immunotherapy timing strategies. Enrollment is coordinated by Fudan University with Shanghai Cancer Center as a key site, under the ECTOP-1030 framework.

Why it matters

Potential benefit: If successful, the trial could identify the most effective timing of toripalimab to improve surgical outcomes and survival for resectable NSCLC patients.

How similar studies have gone: Earlier studies in perioperative immunotherapy have shown promise; this trial tests three timing strategies to determine the most beneficial approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
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), without EGFR/ALK sensitive mutations, 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.

Where it's running

  • Fudan University Shanghai Cancer Center
    Shanghai, China
    Recruiting

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.