A Phase 3 interventional study of SHR-A1811 Injection and Adebrelimab Injection in Non Small Cell Lung Cancer, sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. Not yet recruiting at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd. (part of Jiangsu HengRui Medicine Co., Ltd.) · Phase 3, Interventional, and Treatment
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.
6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.
This study's planned enrollment of 436 is above the median of 62 across 5,327 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Suzhou Suncadia Biopharmaceuticals Co., Ltd. is the lead sponsor of 104 studies on the registry; 73 are open to participants now.
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Exclusion Criteria:
SHR-A1811, Adebrelimab Group.
Drug: SHR-A1811 Injection · Drug: Adebrelimab Injection
Tislelizumab, Pemetrexed, Carboplatin/Cisplatin.
Drug: Tislelizumab Injection · Drug: Pemetrexed Disodium For Injection · Drug: Carboplatin injection · Drug: Cisplatin injection
SHR-A1811 Injection.
Adebrelimab Injection.
Tislelizumab Injection.
Pemetrexed Disodium For Injection.
Carboplatin Injection.
Cisplatin Injection.
Progression-free survival (PFS) based on blinded independent central review (BICR)
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.
Time frame: From randomization until disease progression or death from any cause, whichever occurs first, up to approximately 40 months.
Overall Survival (OS)
OS is defined as the time from randomization to the date of death from any cause.
Time frame: From randomization until death from any cause, up to approximately 50 months.
Progression-Free Survival (PFS) assessed by the Investigator
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 the Investigator.
Time frame: From randomization until disease progression or death from any cause, whichever occurs first, up to approximately 40 months.
Objective Response Rate (ORR) assessed by the Investigator and BICR
ORR is defined as the proportion of participants who achieve a confirmed complete response (CR) or partial response (PR), in accordance with RECIST v1.1, as assessed by the Investigator and BICR.
Time frame: From randomization until confirmed objective response, up to approximately 40 months.
Duration of Response (DoR) assessed by the Investigator and BICR
DoR is defined, in accordance with RECIST v1.1, as the time from the date of the first documented CR or PR to the date of the first documented disease progression or death from any cause, whichever occurs first, as assessed by the Investigator and BICR.
Time frame: From the first documented objective response until disease progression or death from any cause, whichever occurs first, up to approximately 40 months.
Disease Control Rate (DCR) assessed by the Investigator and BICR
DCR is defined as the proportion of participants who achieve a complete response (CR), partial response (PR), or stable disease (SD), in accordance with RECIST v1.1, as assessed by the Investigator and BICR.
Time frame: From randomization until confirmed disease control, up to approximately 40 months.
Incidence and Severity of Adverse Events (AEs), graded according to NCI-CTCAE v6.0
This outcome is defined as the number and proportion of participants experiencing adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation of study treatment. AE severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 6.0.
Time frame: From the first dose of study treatment through 30 days after the last dose, up to approximately 40 months.
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung →
Suzhou Suncadia Biopharmaceuticals Co., Ltd. →