Safety and Efficacy of Aumolertinib Combined With Anlotinib as 1st Line Treatment in Advanced Lung Cancer EGFR Mutation With TP53 Co-Mutation
NCT05778149 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 47
Last updated 2023-03-21
Summary
The goal of this open, single-arm, exploratory phase II clinical study is to exploratory safety and efficacy in 1st line treatment in advanced lung cancer EGFR mutation with TP53 co-mutation. 47 patients are scheduled to be enrolled. Treatment regimen is aumolertinib 110mg p.o QD and Anlotinib 12mg oral for 2 weeks, three weeks a cycle, until disease progression or intolerable adverse reactions or death.
Conditions
- Aumolertinib
- Anlotinib
- TP53
- NSCLC
- EGFR Activating Mutation
Interventions
- DRUG
-
Aumolertinib,Anlotinib
Aumolertinib 110mg p.o QD; Anlotinib 12mg, oral for 2 weeks, three weeks a cycle, until disease progression.
Sponsors & Collaborators
-
Tianjin Medical University Cancer Institute and Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-03-31
- Primary Completion
- 2025-03-31
- Completion
- 2027-03-31
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