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New drug cocktail aims to shrink lung tumors before surgery
NCT ID NCT07438600
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase II trial tests whether combining two drugs—sacituzumab tirumotecan and toripalimab—given before surgery can shrink tumors in people with stage II to IIIB non-small cell lung cancer (NSCLC). About 38 participants will receive the drugs intravenously over several weeks, then have surgery to remove any remaining cancer. The main goal is to see how many patients have no cancer left in their lung tissue after treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sacituzumab tirumotecan (a targeted antibody-drug conjugate) combined with toripalimab (an immunotherapy drug)
- What this could lead to
- If successful, this combination could become a new pre-surgery treatment option for certain non-small cell lung cancers, potentially improving tumor shrinkage and long-term outcomes.
- What could go wrong
- This is a small, early-phase trial with only 38 participants, so results may not apply broadly. The drugs can cause serious side effects like immune-related reactions or low blood cell counts.
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 38 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 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. Age ≥18 years at the time of informed consent signing, either sex; 2. ECOG performance status score of 0-1 within 7 days prior to dosing; 3. Histologically or cytologically confirmed NSCLC; 4. Negative for EGFR sensitive mutations (no exon 19 deletion or exon 21 L858R substitution mutation) and negative for ALK fusion gene; 5. No prior local treatment (surgery or radiotherapy) for NSCLC and no prior systemic antineoplastic therapy, including cytotoxic therapy, targeted therapy (including tyrosine kinase inhibitors or monoclonal antibodies), cellular therapy, immunotherapy, traditional Chinese medicine therapy, and any other investigational drug therapy; 6. Patients with resectable stage II-IIIB NSCLC as assessed by MDT (according to UICC/AJCC 8th edition TNM staging); 7. At least one measurable lesion (according to RECIST 1.1 criteria); 8. Patients who agree to undergo radical surgical treatment; 9. Surgical evaluation confirms operability with no contraindications to surgery; 10. Adequate organ and bone marrow function (no transfusion, recombinant human thrombopoietin, or colony-stimulating factor treatment within 2 weeks prior to first dosing), defined as follows: 1. Hematology: Absolute neutrophil count (NEUT#) ≥ 1.5×10⁹/L; Platelets (PLT) ≥ 100×10⁹/L; Hemoglobin ≥ 90 g/dL; 2. Hepatic function: Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP) ≤ 2.5×upper limit of normal (ULN); Total bilirubin (TBIL) ≤ 1.5×ULN; 3. Renal function: Creatinine clearance (Ccr) ≥ 60 ml/min (Cockcroft-Gault formula, see Appendix); 4. Coagulation function: International normalized ratio (INR), Activated partial thromboplastin time (APTT), and Prothrombin time (PT) ≤ 1.5×ULN; 5. Cardiac function: Echocardiography (ECHO) or Multiple gated acquisition (MUGA) scan showing left ventricular ejection fraction (LVEF) ≥ 50%; 11. For female subjects of childbearing potential and male subjects with partners of childbearing potential, must agree to use effective medical contraception from the time of informed consent signing until 6 months after the last dose (see Appendix 2 for details); 12. Subjects voluntarily participate in this study, sign informed consent, and are able to comply with protocol-specified visits and related procedures. Exclusion Criteria: 1. Histologically or cytologically confirmed combined small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma components; 2. Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies, or any other antibodies or drugs specifically targeting T-cell co-stimulation or checkpoint pathways; 3. Prior treatment with TROP2-targeted therapy and/or topoisomerase I inhibitors; 4. Requirement for strong inhibitors or inducers of cytochrome P450 3A4 enzyme (CYP3A4) within 2 weeks prior to first dosing and during the study (strong CYP3A4 inhibitors or inducers are not permitted in this study; Appendix 6 lists representative drugs of strong CYP3A4 inhibitors or inducers); all subjects must avoid concomitant use of any drugs, herbal supplements, and/or foods known to induce CYP3A4. 5. Other malignancies within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma, or cutaneous squamous cell carcinoma; 6. Known history of hypersensitivity to study drugs and their components, history of immunodeficiency, or history of organ transplantation; 7. History of interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid treatment (non-infectious), current ILD or non-infectious pneumonitis, or suspected ILD or non-infectious pneumonitis that cannot be excluded by imaging at screening; clinically significant pulmonary impairment due to pulmonary comorbidities, including but not limited to any underlying pulmonary disease (such as pulmonary embolism within 3 months prior to dosing, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.) or any autoimmune, connective tissue, or inflammatory disease that may involve the lungs (i.e., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.), or prior pneumonectomy; 8. Active autoimmune disease requiring systemic treatment within the past 2 years (hormone replacement therapy is not considered systemic treatment, such as type 1 diabetes, hypothyroidism requiring only thyroid hormone replacement therapy, adrenal or pituitary insufficiency requiring only physiologic doses of glucocorticoid replacement therapy); 9. Active infection requiring systemic treatment within 2 weeks prior to first dosing; 10. Active hepatitis B \[hepatitis B surface antigen (HBsAg) positive, HBV-DNA testing required; HBV-DNA ≥ 500 IU/mL or above the lower limit of detection, whichever is higher\] or hepatitis C (hepatitis C antibody positive, and HCV-RNA above the lower limit of detection). Note: For HBsAg-positive subjects, anti-hepatitis B virus treatment is required during study treatment; 11. Positive human immunodeficiency virus (HIV) test or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection; 12. Severe concomitant diseases that endanger patient safety or affect study completion, as judged by the investigator, including but not limited to uncontrolled hypertension with medication, severe diabetes, active infection, etc.; 13. Documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or history of corneal disease that prevents delayed corneal healing; 14. Pregnant or lactating women; 15. Any condition that interferes with the evaluation of study drugs, subject safety, or interpretation of study results, or any other condition deemed by the investigator as unsuitable for participation in this 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 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.
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Other studies related to the condition(s) this trial covers.
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