Lung cancer trial seeks optimal immunotherapy schedule around surgery
NCT ID NCT07554846
First seen Jun 25, 2026 · Last updated Sep 11, 2026 · Updated 3 times
Summary
This phase 3 trial compares three ways of giving the immunotherapy drug toripalimab to people with stage II-IIIA non-small cell lung cancer that can be removed with surgery. Participants will receive toripalimab either before surgery (neoadjuvant), after surgery (adjuvant), or both before and after surgery (perioperative), all combined with chemotherapy. The study aims to find which timing best prevents the cancer from returning over three years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Toripalimab (an immunotherapy drug) combined with chemotherapy (pemetrexed and carboplatin or cisplatin)
- What this could lead to
- If successful, this could show the best timing for immunotherapy to prevent lung cancer from coming back after surgery, potentially improving survival rates.
- What could go wrong
- This is an early-stage trial in a specific lung cancer type, and results may not apply to all patients. Immunotherapy can cause immune-related side effects, and the added benefit over standard care is not yet proven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 759 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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May 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fudan University Shanghai Cancer Center
RECRUITINGShanghai, 200032, China