NSCLC
Conditions
Interventions
Observation group:NA
Sponsors
The First Afflicted Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Signed informed consent form before trial (In particular, informed consent form for clinical trial No. 2024-576);(2) Male and female patients, aged >=18 years;(3) patients with locally advanced or metastatic non-squamous NSCLC (stage IIIB/IIIC/IV, disease staging according to the American Joint Committee on Cancer (AJCC)/Union for International Cancer Control (UICC) 8th edition) confirmed by histology or cytology;(4) Patients were required to meet any of the following anti-tumor treatment requirements:a) patients who had not received systemic anti-tumor therapy or pulmonary palliative treatment in the advanced stage, including: 1) patients with initial treatment in the advanced stage; 2)Recurrence after previous surgical treatment should meet the condition of disease recurrence more than 12 months before the completion of radical surgery; Patients who received adjuvant therapy after surgery were required to have disease recurrence more than 12 months after the end of adjuvant therapy. Stage III patients are not suitable for radical surgery and do not receive current standard treatment; b) EGFR tyrosine kinase inhibitor (TKI) treatment in the advanced stage with disease progression or intolerance;(5) Patients were required to have any of the following EGFR mutations: a) EGFR sensitive mutations detected by local laboratory test for patients with advanced NSCLC who had not received systemic anti-tumor therapy; b) T790M mutation detected by local laboratory testing is required for patients with advanced EGFR TKI prior to first-line TKI treatment; (6) An ECOG PS score of 0-1 with no deterioration in the past 2 weeks and a life expectancy of at least 12 weeks. (7) Use of appropriate contraception for male or female patients within 3 months after screening until the last dose of medication, and no breastfeeding for female patients within 3 months after screening until the last dose of medication. (8) If the female patient is fertile, she must undergo a negative pregnancy test within 3 days before starting medication or she must be shown to be infertile at screening.
Exclusion criteria
Exclusion criteria: (1) received or are receiving any of the following: a) prior treatment with a first-generation or second-generation EGFR-TKI within 8 days or within 5 times the half-life of the first dose of study treatment. b) prior treatment with a third-generation EGFR-TKI. c) have received any cytotoxic chemotherapy, study drug, or other anticancer drug for treatment or clinical study within 14 days before the first dose of study treatment. d) patients had undergone major surgery within 4 weeks before the first dose of study treatment. e) received local radiation within 1 week before the first dose of study treatment, if more than 30% of bone marrow was irradiated within 4 weeks before the first dose of study drug, or if a large area of radiation was irradiated. (2) unresolved legacy toxicity of previous treatment of grade >1 according to the Common Terminology Criteria for Adverse Events (CTCAE) at the start of study treatment. Alopecia and grade 2 neurotoxicity from previous platinum therapy were excluded. (3) spinal cord compression or brain metastases, unless asymptomatic, in stable condition, and requiring no steroids for at least 4 weeks prior to starting study treatment; And (4) evidence of any serious or uncontrolled systemic illness, including uncontrolled hypertension or an active predisposition to bleeding that, in the opinion of the investigator, would make the patient ineligible for trial participation or interfere with adherence to the protocol, such as an active infection. No need to screen for chronic diseases; (5) any of the following cardiac criteria were met: a) mean QTc interval > 470 msec from three resting electrocardiograms (ECGs); b) the presence of various clinically significant rhythm, conduction, or ECG morphological abnormalities on resting ECG; c) the presence of any factors that increase the risk of QTc prolongation or arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death in an immediate family member under 40 years of age or any concomitant medication that prolongs the QT interval; d) LVEF<=40%. (6) history of interstitial lung disease, drug-induced interstitial lung disease, history of radiation pneumonitis requiring steroid therapy, or any evidence of clinically active interstitial lung disease; (7) insufficient bone marrow reserve or organ function; (8) Refractory nausea, vomiting, chronic gastrointestinal diseases, inability to swallow study drugs, or history of extensive bowel resection may affect the adequate absorption of study drugs; (9) the patient has any disease or condition that the study physician believes may increase safety risk or interfere with the study assessment; (10) patients with dyspnea or severe apnea syndrome; (11) acute angle-closure glaucoma or untreated open Angle glaucoma; (12) Patients who, as judged by the investigator, had poor adherence to study procedures, restrictions, and requirements and were not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival(PFS);Differences in the expression of serum proteins;Characteristics and differences of serum metabolites; | — |
Countries
China
Contacts
Public ContactHu Xingjiang
The First Afflicted Hospital, Zhejiang University School of Medicine
Outcome results
None listed