Spots Global Cancer Trial Database for Efficacy and Safety of Furmonertinib in Patients With Locally Advanced or Metastatic NSCLC With EGFR Exon 20 Insertion
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Trial Identification
Brief Title: Efficacy and Safety of Furmonertinib in Patients With Locally Advanced or Metastatic NSCLC With EGFR Exon 20 Insertion
Official Title: A Phase 2, Multicenter, Open-Label Study to Assess the Efficacy and Safety of Furmonertinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations
Study ID: NCT05466149
Conditions
Interventions
Study Description
Brief Summary: This is a Phase 2, Multicenter, Open-Label Study to Assess the Efficacy and Safety of Furmonertinib in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations. The study plans to enroll approximately 100 patients from approximately 70 sites. Patients are locally advanced or metastatic NSCLC with EGFR exon 20 insertions who have progressed during or after platinum-based chemotherapy. Furmonertinib Mesilate will be treated 240 mg QD until disease progression or unacceptable toxicity. Primary endpoint is ORR. Secondary endpoints include DOR, DCR, DepOR, PFS, OS, CNS ORR, CNS DOR, CNS PFS, safety and the PK profile of Furmonertinib Mesilate and its metabolites (AST5902).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Jilin Province Cancer Hospital, Changchun, Jilin, China
Contact Details
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