A Study of SHR-A1811 in First-line Treatment of Patients With Advanced or Metastatic Non-small Cell Lung Cancer With HER2 Mutations
A Randomized, Open-Label, Multicenter Phase III Study of SHR-A1811 for First-Line Treatment in Subjects With HER2-Mutated Advanced or Metastatic Non-Small Cell Lung Cancer
Jiangsu HengRui Medicine Co., Ltd.
300 participants
Jul 29, 2024
INTERVENTIONAL
Conditions
Summary
The study is being conducted to evaluate the efficacy, and safety of SHR-A1811 versus Standard of Care as first-line treatment of advanced or metastatic Non-Small Cell Lung Cancer with HER2- Mutations
Eligibility
Inclusion Criteria8
- Able and willing to provide a written informed consent
- 18-75 years old (inclusive of both ends)
- ECOG score of 0 or 1.
- Patients with histologically or cytologically confirmed advanced or metastatic NSCLC.
- Subjects with central laboratory- confirmed functional HER2 mutations
- No prior systemic antitumor therapy (including investigational agents) for advanced or metastatic NSCLC.
- Have at least one measurable lesion outside the central nervous system that meets the criteria defined by RECIST v1.1
- Protocol-defined adequate organ function including cardiac, renal, hepatic function
Exclusion Criteria9
- Mixed lung cancer with small cell components and sarcomatoid carcinoma confirmed by histology or cytology.
- Concurrently carrying other driver gene mutations, and targeted drugs for such driver gene mutations have been approved for market release.
- Subjects with untreated or active metastasis of central nervous system (CNS) tumors, or a history of meningeal metastasis or current meningeal metastasis.
- With poorly controlled tumor-related pain.
- previous or current with other malignancies.
- Subjects with a history of interstitial pneumonia/non-infectious pneumonia requiring hormone therapy, or current interstitial pneumonia/non-infectious pneumonia.
- Subjects with active or previous autoimmune diseases.
- Subjects with uncontrolled or severe cardiovascular diseases.
- Subjects with active hepatitis B or hepatitis C.
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Interventions
Drug: SHR-A1811 administered intravenously every 3 weeks (Q3W)
Drug: PD-1/PD-L1 inhibitors administered intravenously every 3 weeks (Q3W) Drug: Pemetrexed Based on the investigator's choice was administered intravenously every 3 weeks (Q3W) Drug: Paclitaxel Based on the investigator's choice was administered intravenously every 3 weeks (Q3W) Drug: Carboplatin Based on the investigator's choice was administered intravenously every 3 weeks (Q3W) Drug: Cisplatin Based on the investigator's choice was administered intravenously every 3 weeks (Q3W)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06430437