Can a drug duo shrink inoperable lung tumors enough for surgery?
NCT ID NCT07778745
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 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: * 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for NSCLC are added.
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.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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.
- Can a new targeted drug shrink lung tumors?
- Can a targeted drug delivery system shrink lung tumors?
- Can a new drug combo revive the immune System's attack on resistant cancers?
- Can a cell therapy shrink Hard-to-Treat lung tumors?
- Can a nebulized biologic fight lung cancer from the inside out?
- Can a targeted drug tame HER2-Mutant lung cancer?