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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-A1811 combined with Adebelimumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A1811 + Adebrelimab | Drug | This study evaluates a novel, chemotherapy-free neoadjuvant regimen uniquely combining the HER2-targeting ADC SHR-A1811 with the anti-PD-L1 antibody Adebrelimab. This specific combination of a HER2-ADC and an immune checkpoint inhibitor in the pre-operative setting for HER2-altered NSCLC is the primary feature distinguishing this intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| pCR rate | Pathological Complete Response (pCR) Rate is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy. | up to 7 weeks after neoadjuvant |
| Measure | Description | Time Frame |
|---|---|---|
| MPR rate | Major Pathological Response (MPR) Rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes in neoadjuvant therapy. | up to 7 weeks after neoadjuvant |
| ORR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zi ming Li | Contact | 18017321562 | liziming1980@163.com |
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Objective Response Rate (ORR) is defined as the percentage of participants achieving complete response (CR) and partial response (PR) for tumor volume reduction and maintaining the minimum duration requirement based on RECIST v1.1
| up to 7 weeks after neoadjuvant |
| EFS | Event Free Survival (EFS) is defined as the time from randomization until radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause. | up to 3 years |
| OS | Overall survival (OS) is defined as the time from randomization until death from any cause. | up to 3 years |
| Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) | Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | 90 days after the last administration |