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 range18 Years – 75 Years

SexALL

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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.
✕. 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.
✕. Uncontrolled third-space fluid accumulation requiring repeated drainage.
✕. 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.

What they're measuring

pCR rate

Timeframe: up to 7 weeks after neoadjuvant

Trial details

NCT IDNCT07281209

SponsorShanghai Chest Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Zi ming Li

18017321562 liziming1980@163.com

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