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New combo therapy aims to shrink lung tumors before surgery
NCT ID NCT07410975
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving a mix of two immunotherapy drugs (sintilimab and IBI310) plus chemotherapy before surgery can shrink tumors in people with stage II-III non-small cell lung cancer. About 54 participants will receive the treatment and then have surgery. The main goal is to see how many patients have very few live cancer cells left after treatment.
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 54 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Jan 2030
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 years and older
- 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
INCLUSION CRITERIA 1. The patient shall sign the informed consent. 2. Age ≥ 18 years. 3. Histologically or cytologically confirmed non-small-cell lung cancer (NSCLC). 4. No prior anticancer therapy, including (but not limited to) chemotherapy, immunotherapy or radiotherapy. Traditional Chinese medicine given for anticancer intent is permitted provided it was discontinued ≥ 2 weeks before first dose. 5. Investigator-assessed resectable Stage II-IIIB (N3 excluded) NSCLC per AJCC 9th. 6. Non-squamous NSCLC: no EGFR mutation, ALK rearrangement or any other driver mutation with an approved targeted agent. Squamous NSCLC: no known EGFR mutation, ALK rearrangement or other actionable driver mutation. 7. PD-L1 expression negative (22C3 or E1L3N). 8. ECOG performance status 0 or 1. 9. Adequate organ function within 7 days before first dose: * Haemoglobin ≥ 90 g/L (no transfusion within 28 days) * Absolute neutrophil count ≥ 1.5 × 10⁹/L * Platelet count ≥ 100 × 10⁹/L (no platelet transfusion or IL-11 within 14 days) * Creatinine clearance ≥ 60 mL/min (Cockcroft-Gault) * Total bilirubin ≤ 1.5 × ULN (≤ 2.5 × ULN in Gilbert's syndrome or hepatic metastases) * ALT and AST ≤ 3 × ULN * INR or aPTT ≤ 1.5 × ULN * FEV\> 2L, FEV1\> 1L, FEV1/FVC ≥ 70%, DLCO ≥ 70% predicted; or Investigator determination that pulmonary reserve is adequate for planned surgery. 10. Fertile female must have a negative serum pregnancy test within 7 days before first dose. 11. Fertile female and male patients with female partners of childbearing potential must use a highly effective contraceptive method (annual failure rate \< 1 %) from 7 days before first dose until 24 weeks after the last dose. EXCLUSION CRITERIA 1. Major thoracic or abdominal surgery within 28 days before first dose or incomplete recovery from previous surgery. 2. Participants who were systemically treated with corticosteroids (prednisone or other corticosteroids \>10 mg/day) or other immunosuppressive agents for ≥ 7 consecutive days within 14 days before first dose. Except for inhaled or topical corticosteroids, or corticosteroid therapy at physiological replacement doses for adrenal insufficiency; short- courses (\<7 days) corticosteroid use is permitted for the prevention or treatment of non-autoimmune conditions; 3. Participants who received live vaccines (including live attenuated vaccines) within 28 days before first dose. 4. Current or prior interstitial pneumonia or pulmonary diseases requiring systemic glucocorticoids. 5. Presence of any active autoimmune disease or history of autoimmune disease. Except in the following cases: Type 1 diabetes, stable hypothyroidism under hormone replacement therapy, psoriasis or vitiligo not requiring systemic treatment. 6. Other malignancy within 5 years before first dose, except for tumors assessed by the investigator as cured. 7. Uncontrolled comorbidities, including: * Active hepatitis B (HBsAg positive and HBV DNA \> 500 IU/mL or \> 2000 copies/mL) or hepatitis C (HCV antibody and HCV RNA positive). Subjects with HBV DNA ≤ 500 IU/mL who agree to antiviral prophylaxis are eligible. * Known HIV infection or history of AIDS. * Active tuberculosis. * Active infection requiring systemic antibiotics for \> 7 days within 28 days before first dose. * Clinically significant cardiovascular disease: cerebrovascular accident within 6 months, symptomatic heart failure (NYHA class II-IV), unstable angina or myocardial infarction within 6 months, risk of QTc prolongation or arrhythmia. * Urine protein qualitative≥ 2+, and 24-hour urine protein test \> 1g 8. History of allogeneic haematopoietic stem-cell or solid-organ transplantation. 9. Hypersensitivity to antibody therapies (≥ grade 3 NCI-CTCAE v6.0), history of anaphylaxis, uncontrolled asthma, or significant drug allergies. 10. Pregnancy or lactation. 11. Other conditions that may affect the safety or compliance of drug therapy in this study include, but are not limited to, psychiatric disorders, uncontrolled large serosal cavity effusions, or moderate to large serosal cavity effusions requiring repeated drainage (recurring within 2 weeks after intervention), such as pleural effusion, pericardial effusion, or ascites cachexia.
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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 Pulmonary Hospital
RECRUITINGShanghai, Shanghai Municipality, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a tailored drug cocktail beat lung cancer recurrence?
- New drug combo aims to wipe out lung cancer before surgery
- Chemo-Free combo shows promise in lung cancer trial