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Brief Title: SI-B001 Combined With Osimertinib Mesylate Tablets in the Treatment of Recurrent Metastatic Non-small Cell Lung Cancer.
Official Title: A Phase II/III Clinical Study to Evaluate the Efficacy and Safety of SI-B001 in Combination With Osimertinib Mesylate Tablets in the Treatment of Recurrent and Metastatic Non- Small Cell Lung Cancer
Study ID: NCT05020769
Brief Summary: This multi-center, open label Phase II/III clinical study is performed in patients with locally advanced/metastatic NSCLC progressed on prior EGFR-TKI treatment or with non TKI-sensitizing mutation or patients with EGFR exon20ins mutation. This study is investigating the safety and efficacy of SI-B001 at monotherapy RP2D or lower combined with Osimertinib in patients with locally advanced or metastatic NSCLC.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China
The Second Affiliated Hospital of Guilin Medical University, Guilin, Guangxi Zhuang Autonomous Region, China
Sun Yat-sen University Cancer Center (SYSUCC), Guangdong, Guangzhou, China
Name: Li Zhang
Affiliation: Sun Yat-sen University Cancer Center (SYSUCC)
Role: PRINCIPAL_INVESTIGATOR