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Can a drug duo shrink inoperable lung tumors enough for surgery?

NCT ID NCT07778745

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 21, 2026 · Last updated Aug 21, 2026

Summary

This trial is testing whether combining two drugs—an immunotherapy called adebrelimab and a targeted therapy called trastuzumab rezetecan—can shrink tumors in people with stage III HER2-positive lung cancer that cannot be removed surgically. Participants receive several cycles of the drug combination, then may undergo surgery or chemoradiation if the tumor shrinks enough. The goal is to see how well the treatment works at reducing tumor size and whether it helps people live longer without the cancer progressing.

What this could mean

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

Active substance
A combination of two drugs: adebrelimab (an immunotherapy) and trastuzumab rezetecan (a targeted antibody-drug conjugate)
What this could lead to
If successful, this combination could shrink inoperable HER2-positive lung tumors enough to allow surgery, potentially improving long-term survival.
What could go wrong
This is a small, early-phase trial (37 people) without a comparison group, so results may not be conclusive. The drugs can cause side effects like immune-related inflammation or infusion reactions.

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 37 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2029

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: * Aged 18-75 years, male or female. * Histologically or cytologically confirmed stage III unresectable NSCLC per AJCC 9th edition, judged unresectable by institutional MDT team. * Confirmed HER2 alteration: HER2 mutation/amplification detected by tissue NGS, or HER2 protein overexpression (IHC 2+ or 3+). * No prior systemic anti-tumor therapy for NSCLC; prior anti-tumor Chinese herbal medicine allowed if ≥2 weeks washout before first dose. * At least 1 measurable target lesion per RECIST v1.1. * ECOG performance status 0 or 1. * Able to provide tumor tissue specimen (archival ≤6 months or newly biopsied non-irradiated lesion). * FEV1 \>1.0 L and FEV1% predicted \>40% within past 3 months. * Adequate organ function within 7 days before first dose (no blood product/G-CSF support within 14 days): * Hematology: WBC ≥3.0×10⁹/L, ANC ≥1.5×10⁹/L, PLT ≥100×10⁹/L, Hb ≥90g/L * Liver: AST/ALT ≤2.5×ULN (≤5×ULN for liver metastasis), TBIL ≤1.5×ULN * Renal: Serum Cr ≤1.5×ULN or CrCl ≥50 mL/min * Cardiac: LVEF ≥50% by echocardiogram * Fertile male/female participants must use effective contraception during treatment and 6 months after last dose; female participants non-lactating, negative serum HCG within 14 days pre-first dose. * Voluntarily sign written informed consent, good compliance for follow-up. Exclusion Criteria: * Mixed small cell/large cell neuroendocrine/sarcomatoid NSCLC histology. * Concurrent other actionable driver gene alterations (EGFR, ALK, MET, BRAF, RET etc.) besides HER2. * Past or concurrent other malignant tumor (except fully resected cancer ≥5 years without active treatment). * Prior thoracic radiotherapy. * Major surgery within 28 days or minor invasive surgery within 7 days before first dose. * HIV infection, active hepatitis B/C, organ transplant history, congenital/acquired immunodeficiency. * Systemic immune modulators (thymosin, interferon, IL-2) within 4 weeks pre-enrollment. * Uncontrolled severe cardiovascular disease, unstable angina or intervention-required ventricular arrhythmia within 1 month. * Confirmed or suspected interstitial lung disease, severe baseline pulmonary dysfunction interfering with lung toxicity monitoring. * Active uncontrolled ≥2 grade infection within 2 weeks before enrollment. * Active tuberculosis under treatment. * Known hypersensitivity to any component of study drugs or other monoclonal antibodies/fusion proteins. * Any condition judged by investigator to compromise participant safety or trial compliance.

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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

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  1. 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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