Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Two-Drug combo aims to shrink lung tumors before surgery

NCT ID NCT07819578

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

Researchers are testing whether giving toripalimab plus sacituzumab tirumotecan before surgery helps people with resectable non-small cell lung cancer. The trial enrolls about 30 adults with stage II to IIIB disease that has not been treated and lacks certain driver mutations. Participants receive the two drugs intravenously every two weeks for up to six cycles, then undergo surgery if doctors judge the tumor removable. The main goal is to see how many participants have no cancer cells left in the removed tumor and lymph nodes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
toripalimab plus sacituzumab tirumotecan
What this could lead to
If the combination works, it could offer a new pre-surgery option that shrinks lung tumors enough to make removal more effective and lower the chance of recurrence.
What could go wrong
This is a small, single-arm phase II trial with 30 participants, so it cannot prove the combination is better than standard care. The drugs can cause immune-related side effects, and some participants may not become eligible for surgery.

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.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

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: * Signed informed consent obtained before any study procedure. * Age 18 to 75 years, male or female. * Histologically/cytologically confirmed, treatment-naive, resectable or potentially resectable NSCLC: stage II-IIIA and selected IIIB (T3N2, T4N2) per IASLC/UICC TNM 9th edition. * Disease staged as cTNM by PET-CT or by neck/chest/abdominal/pelvic CT plus whole-body bone scan and brain MRI. * Multidisciplinary team including thoracic surgeon judges lesion resectable or potentially resectable. * At least one measurable target lesion per RECIST 1.1. * ECOG performance status 0-1. * Adequate organ function (baseline, no transfusion, rh-EPO, or G-CSF within 2 weeks before first dose): neutrophils ≥1.5 ×10\^9/L; platelets ≥100 ×10\^9/L; hemoglobin ≥9 g/dL. * AST, ALT, ALP ≤2.5 × ULN; TBil ≤1.5 × ULN. * For liver metastases: AST/ALT ≤5 × ULN; TBil ≤2 × ULN. * For liver or bone metastases: ALP ≤5 × ULN. * Creatinine clearance (Cockcroft-Gault) ≥60 mL/min. * INR, APTT, PT ≤1.5 × ULN. * TSH within normal range; if TSH abnormal but T3 and free T4 normal, eligible. * Women of childbearing potential must have a negative pregnancy test within 7 days before first dose and use effective contraception during treatment and until 12 months after last dose; men with partners of childbearing potential must use effective contraception during treatment and until 12 months after last dose. Exclusion Criteria: * Neuroendocrine histology component in tumor pathology. * Known EGFR sensitizing mutation or ALK fusion (for non-squamous NSCLC, EGFR/ALK status must be determined). * Other malignancy within 5 years, except those with clinically negligible metastatic risk and curative treatment intent (e.g., adequately treated carcinoma in situ as per protocol examples). * Severe or uncontrolled comorbidities, including symptomatic cerebrovascular events or liver disease at Child-Pugh grade ≥A. * History of allogeneic stem cell transplantation or solid organ transplantation. * Severe dry eye syndrome, severe meibomian gland dysfunction, severe blepharitis, or corneal disorders that may delay corneal healing. * History of interstitial lung disease requiring steroids, or active ILD. * HIV positive or diagnosed AIDS. * Active tuberculosis. * Uncontrolled active HBV infection (HBsAg positive with HBV-DNA above local upper limit of normal). HBV-DNA must be \<500 IU/mL within 28 days before randomization/inclusion. * Active HCV infection (HCV antibody positive and HCV RNA positive). * Known hypersensitivity to toripalimab or sacituzumab tirumotecan (or excipients). * Live vaccine within 30 days before first dose (except inactivated vaccines allowed where specified by protocol, including local policy). * Any systemic or local anticancer treatment before first study treatment. * Use of traditional Chinese medicines with anticancer indication within 7 days before first dose, or need to continue such drugs during study. * Other investigational drug not discontinued for at least 5 half-lives or 2 months (whichever is longer) before first dose. * Any known or suspected autoimmune disease or immunodeficiency, except primary hypothyroidism (stable, not requiring hormones, or stable on physiologic hormone replacement) and stable type 1 diabetes mellitus with controlled blood glucose. * Medical or psychiatric conditions likely to cause premature discontinuation or compromise safety, sampling, or follow-up, including severe social or compliance risks. * Pregnancy or breastfeeding; unwillingness to use effective contraception as specified. * Any other condition considered unsuitable by investigator.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Non-small cell lung cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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 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 ↗

  2. 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.

More trials for these conditions

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