Can an immune booster after lung cancer surgery keep the disease at bay?
NCT ID NCT07748325
First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time
Summary
This trial asks whether giving sintilimab, an immune checkpoint inhibitor, after complete surgical removal of non-small cell lung cancer can improve outcomes for patients at high risk of recurrence. Participants who already received chemotherapy plus an immune checkpoint inhibitor before surgery are randomly assigned to either receive sintilimab for up to a year or to be observed without additional treatment. The main goal is to see if sintilimab improves the proportion of patients who remain cancer-free at 18 months after surgery, with secondary focus on overall survival and safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Sintilimab, an immune checkpoint inhibitor, given intravenously every 4 weeks for up to 1 year after surgery.
- What this could lead to
- If effective, this could reduce the chance of lung cancer returning after surgery, potentially improving long-term survival for high-risk patients.
- What could go wrong
- This is a phase II trial with a modest size, so results may not be definitive. Sintilimab can cause immune-related side effects, and not all patients may benefit.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Dec 2028
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. Male or female participants aged 18 to 75 years. 2. Histologically or cytologically confirmed non-small cell lung cancer. 3. Completion of 2 to 4 cycles of neoadjuvant immune checkpoint inhibitor therapy combined with chemotherapy, followed by complete (R0) surgical resection. 4. At least one of the following protocol-defined high-risk features for postoperative recurrence: * Pathologic lymph-node involvement; * Postoperative pathologic T2 or higher disease; * Failure to achieve a major pathologic response, defined as more than 10% residual viable tumor cells in the primary tumor; * Pleural invasion; * Intravascular tumor emboli; * High-risk histologic components, including solid, micropapillary, or adenosquamous components; * Detectable molecular residual disease. 5. For participants with lung adenocarcinoma, absence of sensitizing EGFR mutations and ALK rearrangements. Molecular testing is not mandatory for participants with squamous cell carcinoma according to the current protocol. 6. Eastern Cooperative Oncology Group performance status of 0 or 1. 7. Adequate organ function within 7 days before randomization, as demonstrated by all of the following: * Hemoglobin of at least 90 g/L; * Absolute neutrophil count of at least 1.5 × 10\^9/L; * Platelet count of at least 75 × 10\^9/L; * Total bilirubin no greater than 1.5 times the upper limit of normal; * Alanine aminotransferase and aspartate aminotransferase no greater than 2.5 times the upper limit of normal; * Serum creatinine no greater than 1.5 times the upper limit of normal or creatinine clearance of at least 60 mL/min; * Left ventricular ejection fraction of at least 50%; * International normalized ratio or prothrombin time no greater than 1.5 times the upper limit of normal. 8. Women of childbearing potential must have a negative pregnancy test within 7 days before the first dose and must agree to use effective contraception during the study and for 3 months after the last dose of study treatment. Male participants with partners of childbearing potential must agree to use effective contraception during the study and for 8 weeks after the last dose. 9. Ability to understand the study requirements, willingness to provide written informed consent, and ability to comply with study treatment and follow-up procedures. Exclusion Criteria: 1. Small cell lung cancer or non-small cell lung cancer containing a small cell carcinoma component. 2. Incomplete resection, including R1 or R2 resection, or salvage surgery. 3. Clinically significant malnutrition as determined by the investigator. 4. A history of clinically significant immune-related adverse events during prior treatment, including grade 3 or higher immune-mediated pneumonitis, myocarditis, or another serious immune-related adverse event that, in the investigator's judgment, makes further immune checkpoint inhibitor therapy unsafe. 5. Signs, symptoms, or a known history of clinically significant interstitial lung disease. 6. Any severe or uncontrolled concurrent medical condition, including: * Inadequately controlled hypertension; * Grade 2 or higher myocardial ischemia, myocardial infarction, clinically significant arrhythmia, corrected QT interval of at least 480 milliseconds, or New York Heart Association class II or higher heart failure; * Active or uncontrolled infection of grade 2 or higher; * Decompensated liver disease, active hepatitis, or chronic viral hepatitis requiring antiviral therapy; * Renal failure requiring hemodialysis or peritoneal dialysis; * Known human immunodeficiency virus infection, another acquired or congenital immunodeficiency disorder, or a history of organ transplantation; * Poorly controlled diabetes mellitus, defined as fasting blood glucose greater than 10 mmol/L; * Urine protein of 2+ or greater with a 24-hour urinary protein level greater than 1.0 g; * Clinically significant coagulation abnormalities or an increased risk of bleeding; * A seizure disorder requiring treatment. 7. A concurrent active malignancy, except for malignancies specifically permitted by the final protocol. 8. An active autoimmune disease or another immune-mediated disease requiring systemic treatment. 9. Long-term treatment with systemic immunosuppressive therapy or systemic corticosteroids, except for protocol-permitted physiologic replacement therapy. 10. An active psychiatric disorder, cognitive impairment, or another condition that would prevent provision of informed consent or adherence to study treatment and follow-up. 11. Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.
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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
2 sites. 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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Suining Central Hospital
RECRUITINGSuining, Sichuan, China
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West China Hospital, Sichuan University
RECRUITINGChengdu, Sichuan, 610041, China
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