New drug duo aims to shrink lung tumors before surgery
NCT ID NCT07329322
First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 2 times
Summary
This study tests whether a new drug, sacituzumab tirumotecan, given alone or with another drug (osimertinib), can shrink tumors before surgery in people with a specific type of lung cancer (EGFR-mutated non-small cell lung cancer). About 60 adults aged 18-75 who have not had prior treatment will participate. The main goal is to see how many patients have few or no cancer cells left in the removed tumor 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 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Oct 2032
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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, ≥ 18 and ≤ 75 years at the time of signing the informed consent form (ICF). 2. Histologically or cytologically confirmed NSCLC. 3. No prior systemic anti-tumor therapy. 4. No prior local therapy for NSCLC. 5. Confirmed by tumor histology, or cytology to have EGFR sensitizing mutations. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization. 7. At least one target lesion as assessed by the investigator according to RECIST v1.1. 8. Life expectancy ≥ 24 weeks. 9. Adequate organ and bone marrow function. 10. For female participants of childbearing potential and male participants with partners of childbearing potential, they must agree to use effective medical contraception from the start of signing the ICF until 6 months after the last dose. 11. Participants must voluntarily join this study, sign the ICF, and be able to comply with the protocol-specified visits and related procedures. Exclusion Criteria: 1. Tumor histology or cytology confirming combined small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma or squamous cell carcinoma components of more than 10%. 2. Participants with other malignant tumors within 3 years prior to randomization. 3. Resting electrocardiogram (ECG) showing clinically significant abnormal results. 4. Presence of any of the following cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors. 5. Uncontrolled systemic diseases in the investigator's judgment. 6. History of interstitial lung disease (ILD), drug-induced ILD, or non-infectious pneumonitis, have current ILD or non-infectious pneumonitis. 7. Clinically severe lung damage due to complications of lung disorder. 8. Participants who have received systemic corticosteroids therapy with \> 10 mg/day of prednisone or other immunosuppressive drugs within 2 weeks before randomization. 9. Known active pulmonary tuberculosis. 10. Known history of allogeneic organ transplant and allogeneic hematopoietic stem cell transplant. 11. Active hepatitis B. 12. Positive for human immunodeficiency virus (HIV) test or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection. 13. Known hypersensitivity to osimertinib, sacituzumab tirumotecan, or any of their components (including but not limited to polysorbate-20); known history of severe hypersensitivity to other biologics. 14. Have received a live vaccine within 30 days prior to randomization, or plan to receive a live vaccine during the study. 15. Pregnant or lactating women. 16. Any condition that, in the investigator's opinion, would interfere with the evaluation of the study drug, participant safety, or interpretation of study results, or any other condition that the investigator considers 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 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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Cancer Hospital Chinese Academy of Medical Sciences
RECRUITINGBeijing, China
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Other studies related to the condition(s) this trial covers.
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- Two-Drug combo takes aim at Hard-to-Treat lung cancer