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New drug duo aims to shrink lung tumors before surgery

NCT ID NCT07281209

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests two drugs (SHR-A1811 and adebelimumab) given before surgery to people with early-stage non-small cell lung cancer that has a specific genetic change (HER2 alteration). The goal is to see if the combination can shrink or eliminate the tumor before it is removed. About 40 participants will take part in this phase 2 trial.

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 40 people

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

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Jun 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: 1. Having sufficient understanding of this study and being willing to sign the informed consent form (ICF); 2. Aged 18-75 years, male or female; 3. Treatment-naive, histologically confirmed resectable, stage II, IIIA, IIIB (AJCC staging system, version 9) NSCLC 4. HER2 alterations identified by histological specimens; 5. Measurable lesions based on the response evaluation criteria in solid tumors version 1.1 (RECIST v1.1); 6. ECOG score 0-1; 7. No contraindications to immunotherapy; 8. Adequate organ function: 9. Being willing and able to comply with the visits, treatment plan, laboratory examinations and other study procedures scheduled in the study; 10. Pulmonary function being able to withstand the planned surgery evaluated by surgeons; 11. Women of childbearing potential must undergo a serum pregnancy test within 1 week prior to the first dose and the result must be negative. Female patients of childbearing potential and male subjects whose partners are women of childbearing potential must agree to use highly effective contraceptive methods during the study period and within 180 days after the last dose of study drug Exclusion Criteria: 1. Known EGFR sensitizing mutations or ALK fusions. 2. Malignant pleural effusion. Drainable effusions during screening require thoracentesis to rule out malignancy. 3. Prior anticancer therapy (radiotherapy, chemotherapy, immunotherapy), except curatively treated NSCLC with ≥5 years recurrence-free. Anticancer Chinese herbal medicine is allowed if stopped ≥2 weeks prior. 4. Active or history of autoimmune diseases (e.g., uveitis, hepatitis, vasculitis, thyroiditis). Exceptions include: resolved childhood asthma, vitiligo, psoriasis, or alopecia without systemic treatment. Patients requiring bronchodilators are excluded. 5. Immunodeficiency (e.g., HIV), active Hepatitis B (HBsAg+ \& HBV DNA ≥500 IU/mL), or active Hepatitis C (HCV Ab+ \& detectable HCV RNA). Resolved HBV infection (anti-HBc+, HBsAg-) is allowed. 6. Uncontrolled third-space fluid accumulation requiring repeated drainage. 7. Significant proteinuria (urine protein ≥++ and 24-hour protein ≥1.0 g) or severe hepatic/renal impairment. 8. Systemic corticosteroids (\>10 mg/day prednisone equivalent) or immunosuppressants within 14 days prior to first dose. Inhaled/topical steroids or physiologic replacement doses are permitted. 9. Antitumor vaccines or immunostimulatory agents within 1 month prior to first dose. 10. Systemic immunosuppressive therapy within 2 weeks prior to first dose or anticipated need during the study. Short-term, low-dose use may be permitted after Medical Monitor approval. 11. Concurrent participation in another interventional clinical trial or prior interventional drug within 4 weeks (or 5 half-lives). Non-interventional study participation is allowed. 12. Known or suspected interstitial lung disease, or other significant pulmonary conditions that may interfere with drug-related pulmonary toxicity evaluation. 13. Severe cardiovascular disease, including: clinically significant arrhythmias; QTc ≥450 ms (male) or ≥470 ms (female); NYHA Class ≥III heart failure; or LVEF \<50%. 14. Severe infection within 4 weeks prior to first dose, or active infection requiring therapeutic antibiotics within 2 weeks prior (prophylactic antibiotics allowed). 15. Active tuberculosis within 1 year prior to first dose. 16. Major surgery within 28 days prior to first dose. 17. History of allogeneic organ or stem cell transplantation. 18. Pregnancy, lactation, or unwillingness to use effective contraception. 19. Known allergy or hypersensitivity to SHR-A1811/Adebelimumab or their excipients. 20. History of psychoactive drug abuse, alcohol abuse, or drug addiction. 21 Any other condition that may compromise patient safety or study compliance, per investigator's judgment.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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