Clinical Study of Ametinib Combined With Bevacizumab in First-line Treatment of Advanced NSCLC With EGFR-mutations.

Sponsor
The Second Affiliated Hospital of Shandong First Medical University
Study ID
NCT05754736
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

To explore the intracranial/extracranial ORR, PFS, QoL, safety, dynamic changes of tissue, cerebrospinal fluid, and plasma DNA in patients with newly diagnosed advanced NSCLC with EGFR mutation with/without brain metastasis given first-line treatment with almonertinib combined with bevacizumab at the initial stage of treatment, during treatment and after drug resistance, and the correlation between early clearance of sensitive mutations and survival.

Key Dates

First listed
Mar 6, 2023
Start date
Dec 1, 2022
Status verified
Feb 2023
Primary completion
Dec 1, 2023
Completion
Dec 1, 2025

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ametinib combined with bevacizumab
    Ametinib 110 mg po qd bevacizumab 15mg/kg ivdrip q3w

Primary Outcome Measure

Objective Response Rate [ Time Frame: 2 years ]

Central Contacts

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