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Lung cancer trial seeks optimal immunotherapy schedule around surgery

NCT ID NCT07554846

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 759 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

May 2032

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, 200032, China