A Study of SHR-A1811 Combined With Adebelimumab as Neoadjuvant Therapy for Resectable HER2-Altere… (NCT07281209) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Study of SHR-A1811 Combined With Adebelimumab as Neoadjuvant Therapy for Resectable HER2-Altered Non-Small Cell Lung Cancer
40 participantsStarted 2025-12
Plain-language summary
This is a prospective, single-arm, multi-center Phase II clinical trial designed to evaluate the efficacy and safety of neoadjuvant therapy with SHR-A1811 in combination with Adebelimumab in patients with resectable, early-stage non-small cell lung cancer (NSCLC) harboring HER2 alterations.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Having sufficient understanding of this study and being willing to sign the informed consent form (ICF);
. Aged 18-75 years, male or female;
. Treatment-naive, histologically confirmed resectable, stage II, IIIA, IIIB (AJCC staging system, version 9) NSCLC
. HER2 alterations identified by histological specimens;
. Measurable lesions based on the response evaluation criteria in solid tumors version 1.1 (RECIST v1.1);
. ECOG score 0-1;
. No contraindications to immunotherapy;
. Adequate organ function:
Exclusion criteria
. Known EGFR sensitizing mutations or ALK fusions.
. Malignant pleural effusion. Drainable effusions during screening require thoracentesis to rule out malignancy.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.
. 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.
. Significant proteinuria (urine protein ≥++ and 24-hour protein ≥1.0 g) or severe hepatic/renal impairment.
. 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.