Can two targeted drugs keep HER2 lung cancer from coming back?
NCT ID NCT07836543
First seen Sep 23, 2026 · Last updated Sep 24, 2026 · Updated 1 time
Summary
Researchers are testing whether adding trastuzumab rezetecan, adebrelimab, or both after chemoradiotherapy can help people with unresectable stage III non-small cell lung cancer that has HER2 changes. The trial enrolls about 105 adults whose cancer has not worsened after definitive chemoradiotherapy. Participants receive one of the drug combinations for up to a year, and researchers track how long they live 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
- trastuzumab rezetecan and adebrelimab
- What this could lead to
- If it works, this could offer a new way to keep stage III HER2-altered lung cancer from returning after chemoradiotherapy.
- What could go wrong
- This is a phase 2 trial, so it cannot prove the approach works. The drugs can cause serious side effects, and the results may not apply to all patients with this cancer type.
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 105 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2031
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- 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. Age ≥18 years. 2. ECOG performance status 0-1. 3. Histologically or cytologically confirmed Non-Small Cell Lung Cancer (NSCLC). 4. Radiologically confirmed unresectable Stage III NSCLC per AJCC 9th edition. 5. Pathologically confirmed HER2 mutation or HER2 overexpression (IHC 2+ or 3+). 6. Life expectancy ≥3 months. 7. Completed at least two cycles of platinum-based chemotherapy (concurrent or sequential) with definitive radiotherapy. Consolidation chemotherapy after radiotherapy is not permitted; chemotherapy with or without immunotherapy before concurrent chemoradiotherapy is permitted. 8. Total radiotherapy dose 60 Gy ± 10% (54-66 Gy) using IMRT (preferred) or 3D-CRT, with acceptable dosimetric constraints. 9. Adequate organ and bone marrow function. 10. Negative pregnancy test for women of childbearing potential within 7 days prior to first dose. Willing to use effective contraception during the study and for 180 days after the last dose. 11. Signed informed consent form (ICF). Exclusion Criteria: 1. Known EGFR-activating mutations or ALK fusions. 2. Presence of other driver gene mutations with approved targeted therapies available. 3. Mixed SCLC and NSCLC, large cell neuroendocrine carcinoma, or sarcomatoid carcinoma. 4. Prior treatment with HER2-targeted ADCs or HER2 TKIs. 5. Malignant pleural effusion, pericardial effusion, or ascites. 6. Participation in another clinical trial within 4 weeks or 5 half-lives prior to first dose. 7. Systemic immunosuppressive therapy within 2 weeks prior to first dose. 8. Known HIV infection. 9. Active hepatitis B (HBsAg positive with detectable HBV-DNA and ALT \> ULN) or active hepatitis C. 10. Active autoimmune disease requiring systemic treatment. 11. Other malignancies within 5 years, except adequately treated cervical carcinoma in situ, basal/squamous cell skin carcinoma, localized prostate cancer, or ductal carcinoma in situ. 12. Active or history of Grade ≥2 radiation pneumonitis per RTOG/EORTC, or symptomatic interstitial lung disease. Participants with grade 2 radiation pneumonitis that resolves to grade 1 or lower within 14 days without systemic glucocorticoid treatment may undergo screening if the investigator considers there to be no risk of recurrence. 13. Significant cardiovascular disease. 14. Severe infection within 4 weeks prior to first dose. 15. Prior or planned allogeneic bone marrow or solid organ transplantation. 16. Live attenuated vaccine within 28 days prior to first dose or planned during study. Pregnancy or breastfeeding. 17. Known hypersensitivity to Adebrelimab, Trastuzumab Rezetecan, or any excipients. 18. Known history of psychotropic substance abuse, alcohol abuse, or illicit drug use. 19. Any condition that might impair the subject's ability to comply with study requirements.
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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 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.
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Other studies related to the condition(s) this trial covers.
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- Can daily EGFR pills keep early lung cancer from returning after surgery?
- Double attack on HER2: two drugs combined against Hard-to-Treat lung cancer