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New drug duo aims to shrink lung tumors before surgery

NCT ID NCT07329322

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Oct 2032

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Cancer Hospital Chinese Academy of Medical Sciences

    RECRUITING

    Beijing, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.