A Study of SHR-A1811 in First-line Treatment of Patients With Advanced or Metastatic Non-small Cell Lung Cancer With HER2 Mutations
Recruiting now · Phase 3
Conditions studied: Non-Small Cell Lung Cancer With HER2- Mutations
In brief
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
Key facts
- Study ID
- NCT06430437
- Run by
- Jiangsu HengRui Medicine Co., Ltd.
- People needed
- 300
- Starts
- 2024-07-29
- Expected to finish
- 2027-04-01
- Last updated by the study team
- 2026-01-21
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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