EGFR 21L858R-mutated locally advanced or metastatic non-small cell lung cancer
Conditions
Interventions
EGFR 21L858R mutation:Beritinib 100mg, BID, in combination with third-generation EGFR-TKI(the specific dosage is determined by the investigator), continuous administration, with 28 days as one treatme
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Signed an informed consent form. 2. Patients aged >=18. 3. Histologically or cytologically confirmed locally or metastatic NSCLC. 4.EGFR 21 L858R mutation. 5.At least one measurable lesion according to RECIST 1.1 criteria. 6.ECOG PS 0-1. 7.Appropriate organ function. 8.For female subjects of reproductive age, a urine or serum pregnancy test should be performed negative within 7 days prior to receiving the first study drug administration .If there is a risk of conception, all subjects (male or female) must agree to use effective contraception from the time they sign an informed consent until 3 months after the final administration of the study drug. 9.The expected survival is more than 3 months.
Exclusion criteria
Exclusion criteria: 1.Patients with EGFR 19del mutation , ALK or ROS1 gene fusions. 2. Patients with symptomatic, neurologically unstable central nervous system (CNS) metastases, or CNS diseases that require increased steroid doses to control. 3. Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years. Exceptions to this exclusion include: completely resected basal cell and squamous cell skin cancers, and completely resected carcinoma in situ of any type. 4.Previous treatment history meets one of the following criteria: (1)prior treated with systemic treatment(If patients received third-generation EGFR-TKI or chemotherapy for less than 3 weeks as first-line treatment and did not develop disease progression, they could be enrolled). (2)Thoracic radiotherapy to lung fields (including whole brain radiotherapy) 470 ms, Severe cardiac arrhythmia; Any risk factors that increase the length of the QTc; New York College of Cardiology (NYHA) Heart function grade >=3. Poorly controlled hypertension. 9.Have a history of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonia requiring steroid therapy, or are currently receiving drug therapy or other clinical interventions, or have existing active interstitial lung disease. 10.A history of thromboembolic or venous thromboembolic events (including myocardial infarction, cerebrovascular event or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or any other severe thromboembolic event) in the 6 months prior to the initial study drug administration, Any life-threatening bleeding event (including treatment requiring blood transfusion, surgery or local treatment, and ongoing medication) was judged to have a bleeding tendency. 11.Active gastrointestinal disorders (such as ulcerative lesions, uncontrolled nausea, vomiting, diarrhea, and malabsorption syndrome) or other conditions (such as inability to swallow the investigational agent, or prior major gastrointestinal surgery) may significantly affect the absorption, distribution, metabolism, or excretion of the oral investigational agent. 12.Patients with poorly controlled pleural effusion, peritoneal effusion, or pericardial effusion were judged by the investigators to be unsuitable for inclusion. 13.Any systemic disease that the investigator determines to require treatment . 14.A history of acute o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of relief;Objective response rate;Disease control rate;Overall survival; | — |
Countries
China
Contacts
Public ContactShi Yuankai
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed