HARMONi-7：晚期非小细胞肺癌一线依沃西单抗 🆚 帕博利珠单抗
A Randomized, Double-blinded, Multiregional Phase 3 Study of Ivonescimab Versus Pembrolizumab for the First-line Treatment of Metastatic Non-small Cell Lung Cancer in Patients Whose Tumors Demonstrate High PD-L1 Expression (TPS ≥ 50%)
HARMONi-7 Study Design
Monotherapy Ivonescimab vs. Pembrolizumab
Key Eligibility Criteria- Metastatic (Stage IV) NSCLC, PD-1 ≥50%
- ECOG 0 or 1
- Histologically or cytologically confirmed squamous or non-squamous NSCLC. No histologic or cytopathologic evidence of the presence of small cell lung carcinoma
- Patients’ tumor must have high PD-L1 expression
- No prior systemic treatment for metastatic NSCLC
- No known actionable genomic alterations in EGFR, ALK, ROS1 or BRAF V600E for which first-line approved therapies are available
- No radiologically documented evidence of major blood vessel invasion, or tumor invading organs, or major blood vessel encasement with narrowing of the vessel or intratumor lung cavitation or necrosis that the investigator determines will pose a significantly increased risk of bleeding
- No symptomatic CNS metastases or CNS metastases with hemorrhagic features or CNS metastases ≥1.5 cm
- No history of bleeding tendencies or coagulopathy and/or clinically significant bleeding symptoms or risk within 4 weeks
NCT06767514: Click to view on ClinicalTrials.gov
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