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Clinical Trials in China / NCT07896005
Starting soon Phase 3

A Study of SHR-A1811 Combined With Adebrelimab for the First-line HER2-overexpressing Non-squamous Non-small Cell Lung Cancer

NCT07896005 · tracked via the Priya Life Science China tracker
Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd
Phase
Phase 3
Started
2026-12
Last updated
2026-10-26

Condition(s) studied

Non Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

SHR-A1811 Injection →Adebrelimab Injection →Tislelizumab Injection →Pemetrexed Disodium For Injection →Carboplatin injection →Cisplatin injection →

SHR-A1811 Injection: SHR-A1811 Injection.

Adebrelimab Injection: Adebrelimab Injection.

Tislelizumab Injection: Tislelizumab Injection.

Pemetrexed Disodium For Injection: Pemetrexed Disodium For Injection.

Carboplatin injection: Carboplatin Injection.

Cisplatin injection: Cisplatin Injection.

Study summary

This is a randomized, open-label, multicenter, phase 3 clinical study comparing the efficacy and safety of SHR-A1811 in combination with Adebrelimab versus platinum-based doublet chemotherapy in combination with Tislelizumab as first-line treatment in patients with HER2-overexpressing locally advanced or metastatic non-squamous non-small cell lung cancer.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Able to provide informed consent, willing and able to comply with the scheduled visits, examinations, and other procedural requirements of the treatment. 2. Aged 18-75 years (inclusive) at the time of signing the informed consent form, with no restriction on sex. 3. ECOG score of 0 or 1. 4. Patients with histologically confirmed locally advanced or metastatic non-squamous NSCLC. 5. Participants with HER2 overexpression confirmed by a central laboratory. 6. Have not previously received systemic antitumor therapy for locally advanced or metastatic NSCLC. Exclusion Criteria: 1. Participants with untreated or active metastasis of central nervous system (CNS) tumors, or a history of meningeal metastasis or current meningeal metastasis. 2. Previous or current with other malignancies. 3. Prior antitumor toxicity and/or complications have not recovered to NCI-CTCAE ≤ Grade 1. 4. Currently participating in another clinical study, or the interval between the start of study treatment and the end of the previous clinical study is less than specified period. 5. Participants with active or previous autoimmune diseases. 6. Participants with uncontrolled or severe cardiovascular diseases. 7. Participants with active hepatitis B or hepatitis C.

Primary outcome measure(s)

  • Progression-free survival (PFS) based on blinded independent central review (BICR) — From randomization until disease progression or death from any cause, whichever occurs first, up to approximately 40 months.
    PFS is defined, in accordance with RECIST v1.1, as the time from randomization to the date of the first documented disease progression or death from any cause, whichever occurs first, as assessed by BICR.

Trial sites (2)

FacilityCityRegionStatus
Shanghai Chest Hospital Shanghai Shanghai Municipality
Zhejiang Cancer Hospital Hangzhou Zhejiang

More Suzhou Suncadia Biopharmaceuticals Co., Ltd. trials in China

A Trial of SHR-7782 for Treatment of Advanced Malignant Tumors Recruiting
A Trial of SHR-2017 Injection in Patients With Bone Metastases From Solid Tumors Recruiting
A Clinical Study of SHR-1316 (SC) Combined With Carboplatin and Etoposide as First-line Treatment for Extensive Stage Small Cell Lung Cancer Active, not recruiting
A Clinical Study of SHR-A1811 in Combination With Chemotherapy and Bevacizumab Versus Standard Therapy as First-Line Treatment for Advanced Colorectal Cancer Recruiting
A Trial of Adebrelimab Plus (SHR-A1811/SHR-A1904 With Chemotherapy) or SHR-8068 as Treatment for Gastric/GEJ Cancer Recruiting

Other trials for the same condition

A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC Recruiting
A Clinical Study of LM103 Injection in the Treatment of Advanced Solid Tumors Recruiting
Lobectomy-First vs. Lymphadenectomy-First for Operable NSCLC (LOFTY) Active, not recruiting
The Efficacy and Safety of LMV-12 Combined With Osimertinib in NSCLC Recruiting
NAD+ Supplement（NMN）With Radioimmunotherapy in Advanced NSCLC Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07896005 on ClinicalTrials.gov ↗ ← All trials in China