Efficacy and Safety of Ametinib Combined With Bevacizumab in First-line Treatment of Non-oligometastatic Advanced NSCLC With EGFR-mutations.

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Male or female, ≥18 years old and ≤75years old;

⁃ Non-squamous non-small cell lung cancer (NSCLC) confirmed by pathology (including histology or cytology); ③ EGFR mutation positive (exon 19 deletion or exon 21 L858R mutation); (4) ≥3 intracranial metastases, asymptomatic brain metastases; (5) Never received antitumor therapy before;

‣ There was at least 1 measurable intracranial and extracranial lesion in CT/MRI according to RECIST1.1 criteria.

‣ ⑦ Predicted survival ≥3 months;

‣ ⑧ ECOG score 0-1;

‣ ⑨ The main organs (liver, kidney, heart) function normally.

‣ ⑩ Sign informed consent forms.

Locations
Other Locations
China
The Second Affiliated Hospital of Shandong First Medical University
RECRUITING
Tai’an
Contact Information
Primary
Ying Kong
kongyingcoco@163.com
13153882807
Time Frame
Start Date: 2022-12-01
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 50
Treatments
Experimental: Ametinib combined with bevacizumab
Ametinib 110 mg po qd bevacizumab 15mg/kg ivdrip q3w
Sponsors
Leads: The Second Affiliated Hospital of Shandong First Medical University

This content was sourced from clinicaltrials.gov

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