Blood test could guide who needs extra cancer therapy after lung surgery
NCT ID NCT06426511
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a blood test that detects tiny bits of tumor DNA (ctDNA) can help doctors decide who needs additional immunotherapy (toripalimab) after lung cancer surgery. About 80 people with stage IB-IIIA non-small-cell lung cancer will be enrolled. The goal is to see if this personalized approach works as well as giving everyone the same long course of treatment, potentially sparing some patients from unnecessary therapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Toripalimab (a drug that helps the immune system fight cancer)
- What this could lead to
- If successful, this could mean that some people with lung cancer can receive less treatment after surgery, reducing side effects while still preventing the cancer from coming back.
- What could go wrong
- This is a small, early-phase trial (Phase 2) with only 80 participants, so results may not apply to everyone. The ctDNA-guided approach might not be as effective as standard treatment in preventing cancer recurrence.
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 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Dec 2029
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: * Subjects must have undergone complete surgical resection (R0) of their stage IB , II and select IIIA NSCLC according to the AJCC 8th edition staging; * Squamous or non-squamous NSCLC histology; * Subjects should be without EGFR or ALK alterations for nonsquamous NSCLC; * Male and female, aged 18-75 years; * Surgery for lung cancer must be completed ≤ 60 days prior to study treatment; * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; * Adequate hematological function: Absolute neutrophil count (ANC) ≥2.0 x 109/L, and Platelet count ≥100 x 109/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level); * Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN; * Adequate renal function: Serum creatinine ≤ 1.25 x ULN, or ≥ 60 ml/min; * Female subjects should not be pregnant or breast-feeding; * Written informed consent provided. Being willing and able to comply with the visits, treatment plan, laboratory examinations and other study procedures scheduled in the study. Exclusion Criteria: * Not R0 resection, or metastatic disease. * Subjects with known EGFR sensitive mutations or ALK translocation, EGFR and ALK mutation status needs to be identified for the subjects with non-squamous NSCLC; * Previous treatment with systemic antitumor therapy for NSCLC; * Severe allergic reaction to other monoclonal antibodies; * Subjects with any known or suspected autoimmune disorder or immunodeficiency, with the following exceptions: hypothyroidism, hormone therapy is not needed, or well controlled at physiological dose; controlled type I diabetes; * Uncontrolled active hepatitis B (defined as positive hepatitis B surface antigen in screening period with HBV-DNA detected higher than the upper limit of normal at the clinical laboratory of the study center); active hepatitis C (defined as positive hepatitis C surface antibody in screening period and positive HCV-RNA); * Vaccination of live vaccine within 30 days prior to the first dose; * Evidence of clinically active interstitial lung disease; * Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS); * Inability to comply with protocol or study procedures; * Any unstable systemic disease (including active infection, active tuberculosis uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease); * A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study and may confuse the study results; * History of another malignancy in the last 5 years with the exception of the following: other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted. Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted. * Women who are pregnant or nursing. * Ingredients mixed with small cell lung cancer patients.
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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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Sun Yat-sen University Cancer Center
RECRUITINGGuangzhou, Guangdong, 510060, China
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Other studies related to the condition(s) this trial covers.
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