Lung cancer
Conditions
Interventions
Experimental group:Furmonertinib+Icotinib
Sponsors
Affiliated Hospital of Guangdong Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged above 18 years (including 18 years old); 2. ECOG physical condition score is 0-1; There was no deterioration within 2 weeks before the score; Subject life expectancy >= 12 weeks; 3. Initially-treated locally advanced or metastatic lung adenocarcinoma with non-operable and non-radical radiotherapy assessed by investigators (AJCC Version 8 TNM stage IIIB, IIIC, or IV); 4. A histological or cytological report issued or certified by a tertiary level A hospital or a qualified testing institution confirms the presence of at least one of the following EGFR-sensitive mutations: Ex19del or L858R (either alone or with a mixed mutant genotype); 5. No previous systematic antitumor therapy for advanced/metastatic non-small cell lung cancer; 6. According to RECIST1.1, the subject has at least one lesion that has not been irradiated in the past and has not received tissue biopsy during the screening period, which can be accurately measured; 7. Adequate bone marrow reserve and organ function; 8. The subjects voluntarily joined the study and signed the informed consent with good compliance.
Exclusion criteria
Exclusion criteria: 1. There is spinal cord compression or symptomatic brain metastasis; 2. Suffering from or having a history of other malignant tumors; 3. Clinically severe gastrointestinal dysfunction; 4. Prolonged QT interval or any clinically important rhythm abnormalities; 5. Active infection of HBV, HCV or HIV; 6. Known history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonia requiring steroid treatment; 7. Known or suspected allergy to the investigational drug and/or its principal ingredient; 8. Pregnant or lactating female patients; 9. The investigator determined that the patient had any disease or medical condition that was unstable or might affect his safety or study compliance, such as uncontrolled hypertension, uncontrolled diabetes, and an active bleeding prone constitution.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;Duration of response;Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactChen Hualin
Affiliated Hospital of Guangdong Medical University
Outcome results
None listed