Overview
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.
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.
Eligibility
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.
- There was at least 1 measurable intracranial and extracranial lesion in
CT/MRI according to RECIST1.1 criteria.
- 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;
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.
- 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;