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Trial Title:
Clinical Study of Ametinib Combined With Bevacizumab in First-line Treatment of Advanced NSCLC With EGFR-mutations.
NCT ID:
NCT05754736
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Bevacizumab
Conditions: Keywords:
Non-small Cell Lung Cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Ametinib combined with bevacizumab
Description:
Ametinib 110mg po qd bevacizumab 15mg/kg ivdrip q3w
Arm group label:
Ametinib combined with bevacizumab
Other name:
Third-generation TKI combined with antivascular targeting drug
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.
Detailed description:
This is a one-arm prospective study to evaluate the first-line treatment of amitinib in
combination with bevacizumab in patients with advanced NSCLC with EGFR mutations
Effectiveness and safety. Subjects received amitinib and bevacizumab during the treatment
cycle and were evaluated for efficacy every 6-8 weeks. Subject receives medication until
disease progression, intolerable toxicity, or withdrawal of informed consent. The primary
endpoint was progression-free survival as measured by the solid tumor Response Assessment
Criteria (RECIST v1.1). Primary endpoints included objective response rate (ORR),
progression-free period (PFS), and secondary endpoints included objective response rate
(iORR), progression-free period (iPFS), overall survival (OS), quality of life (QoL), and
safety.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- The intracranial metastases were oligometastases;
- There are symptoms of increased intracranial pressure; (3) Previous or
co-existing malignancies (except cured basal cell carcinoma of the skin and
carcinoma in situ of the cervix); (4) Patients with hypertension and can not be
reduced to the normal range after antihypertensive drug treatment, have grade I
coronary heart disease, grade I arrhythmia and grade I cardiac insufficiency;
- Patients with definite tendency to gastrointestinal bleeding; ⑥ with
hemoptysis symptoms; ⑦ Abnormal coagulation function (INR>1.5, APTT>1.5
ULN), with bleeding tendency; ⑧ Have a history of psychotropic drug abuse
and can not abstain or have mental disorders; ⑨According to the
investigator's judgment, Patients who have a serious concomitant disease
that endangers the patient's safety or affects the patient's completion of
the study, and who have previous or current objective evidence of
pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation
pneumonia, drug-related pneumonia, or severe impairment of lung function.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Second Affiliated Hospital of Shandong First Medical University
Address:
City:
Tai'an
Zip:
271000
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhensheng Fang
Phone:
+86-0538-6236830
Email:
sdtatszhenhua@126.com
Investigator:
Last name:
Haiyan Liu
Email:
Principal Investigator
Start date:
December 1, 2022
Completion date:
December 1, 2025
Lead sponsor:
Agency:
The Second Affiliated Hospital of Shandong First Medical University
Agency class:
Other
Source:
The Second Affiliated Hospital of Shandong First Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05754736
