Could radiation plus immunotherapy replace chemo before lung cancer surgery?
NCT ID NCT05798845
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two treatments given before surgery for stage II-IIIA non-small cell lung cancer: immunotherapy (toripalimab) plus radiation versus immunotherapy plus chemotherapy. About 124 adults aged 18-75 will take part. The goal is to see which combination works better at shrinking tumors and is safer, with the hope of improving long-term outcomes.
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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 124 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Dec 2026
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. Age 18 to 75 years old, gender is not limited. 2. ECOG performance status 0-1. 3. non-small cell lung cancer diagnosed by pathology. 4. sufficient tumor tissue available for biomarker analysis. 5. clinical staging of cT1-2N1-2M0 or T3N1M0, stage II-IIIA (8th UICC staging criteria). 6. Patients with distant metastases ruled out by CT or PET/CT and physically assessed as acceptable for radical lung cancer surgery. 7. histomolecular pathology confirming the absence of classic driver oncogene mutations in EGFR, ALK, or ROS1. 8. Basic normal function of all organs (laboratory test results within 1 week prior to enrollment). * Bone marrow function: absolute neutrophil count (ANC) ≥ 1.5x109 /L, platelet count ≥ 100x109 /L, hemoglobin ≥ 9g/dL. * Liver: serum total bilirubin ≤ 1.5 times the upper limit of normal; ALT and AST ≤ 2.5 times the upper limit of normal. * Kidney: blood creatinine level ≤ 1.5 times the upper limit of normal or creatinine clearance ≥ 60 ml/min and urea nitrogen ≤ 200 mg/L. * Urine protein \<+, if urine protein + then total 24 hour protein must be \<500mg. * Blood glucose: within normal range and/or with diabetic patients on treatment but with stable blood glucose control. * Pulmonary function: baseline FEV1 of at least 2L; if baseline FEV1 \< 2L then FEV1 \> 800ml is expected after surgery as assessed by a surgical specialist. * Cardiac function: no myocardial infarction within 1 year; no unstable angina; no symptomatic severe arrhythmia; no cardiac insufficiency. 9. Voluntarily participated in this study and signed the informed consent form by himself or his agent Exclusion Criteria: 1. Pathology suggestive of compound small cell lung cancer, etc. 2. History of previous lobectomy, radiotherapy or chemotherapy. 3. Those with concurrent second primary carcinoma and a history of previous malignancy of less than 5 years (except for completely cured cervical carcinoma in situ or basal cell or squamous epithelial cell skin cancer). 4. Patients with any active autoimmune disease or a history of autoimmune disease (e.g., interstitial pneumonia, uveitis, enterocolitis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism, etc.). 5. Have an active infection requiring systemic treatment or a history of active tuberculosis. 6. Known history of human immunodeficiency virus (HIV) or active chronic Hepatitis C or Hepatitis B virus infection or any uncontrolled active systemic infection requiring intravenous (iv) antimicrobial treatment. 7. Those with known presence or coexistence of other uncontrollable diseases that are not amenable to surgical treatment 8. Physical examination or clinical trial finds that, in the opinion of the investigator, may interfere with the results or place the patient at increased risk for treatment complications 9. Prior interstitial lung disease, drug-induced interstitial disease or any clinically evident active interstitial lung disease with idiopathic pulmonary fibrosis on baseline CT scan; uncontrolled massive pleural or pericardial effusion 10. Unstable systemic concomitant disease (active infection, moderate to severe chronic obstructive pulmonary disease, poorly controlled hypertensive disease, unstable angina pectoris, congestive heart failure, myocardial infarction occurring within 6 months, severe mental disorder requiring medication for control, liver, renal or other metabolic disease, neuropsychiatric pathology such as Alzheimer's disease) 11. History of congenital or acquired immunodeficiency disorders or organ transplantation 12. Received any of the following treatments: * Prior radiotherapy, treatment with anti PD-1, anti PD-L1 or anti PD-L2 drugs, or other drugs that synergistically inhibit T-cell receptors such as CTLA-4, OX-40, CD137. * Having received any investigational drug within 4 weeks * Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or an interventional clinical study follow-up * Persons who have received an antineoplastic vaccine or who have received a live vaccine within 4 weeks * Have undergone major surgery or had severe trauma within 4 weeks
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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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Shanghai Chest Hospital
RECRUITINGShanghai, Shanghai Municipality, 200030, China
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