Lung cancer
Conditions
Interventions
Furmonertinib Group:Furmonertinib 160mg daily
Sponsors
Anqing Municipal Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Provide an informed consent form signed by the patient or his/her legal representative; 2.At least 18 years of age; 3.Histologically or cytologically confirmed metastatic NSCLC (TNM stage IV); 4.Patient with EGFR 19Del or L858R mutation in combination with co-occurring genetic alterations diagnosed histologically or cytologically, the reports must be issued or recognized by central laboratory. The mutations above may exist alone or together; 5.ECOG PS of 0 to 1, life expectancy >=12 weeks; 6.According to RECIST 1.1, patients have at least one tumor lesion at baseline that meets the following requirements: accurately and repeatably measurable at baseline; 7.The patient has not received systemic anti-tumor therapy for advanced/metastatic non-small cell lung cancer; 8.Adequate organ reserve function (bone marrow, liver and kidney function, coagulation function); 9.Voluntary and agree to follow the study treatment protocol as well as follow-up plan, and can accept the oral medicine treatment;
Exclusion criteria
Exclusion criteria: 1.History of hypersensitivity to active or inactive excipients of investigational product (IP) or drugs with a similar chemical structure or class to investigational product (IP); 2.Confirmed EGFR 20 exon insertion mutations or other rare mutations in EGFR (G719S, L816Q, S7618I mutations); 3.Prior treatment with any systemic anti-cancer therapy for advanced Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiation including chemotherapy, biologic therapy, target therapy, immunotherapy, or any investigational drug; 4.Diagnosed other malignant tumors or had a history of other malignant tumors in last 5 years, except for skin basal cell carcinoma, cervical carcinoma in situ and breast ductal carcinoma in situ which have been effectively controlled; 5.Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, which in the Investigator's opinion makes it undesirable for the patient to participate in the trial; 6.Combined with other serious diseases such as active or uncontrolled infections (tuberculosis, HIV, etc.), decompensated liver disease, active hepatitis, active bleeding; patients with cerebrovascular accidents or pulmonary embolisms; active, known or suspected autoimmune diseases; 7.Any significant clinical and laboratory abnormality that may affect the safety evaluation, including (i) patients with ventricular arrhythmia, supraventricular arrhythmia, junctional arrhythmia, or fast-ventricular-rate atrial fibrillation requiring pharmacologic control with a QTc interval (QTcB) of >480ms; (ii) patients with class III or greater congestive heart failure (NCI-CTC AE v5.0) within 6 months prior to screening, uncontrolled or still unstable angina or myocardial infarction; and (iii) extensive interstitial pneumonitis requiring pharmacological treatment; 8.Patient who receive prior treatment including any of the following: (1)Any Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI); (2)The patients who have received intrapleural perfusion therapy can only be enrolled 14 days or more after the pleural effusion is stable; (3)Major surgery within 4 weeks of the first dose of investigational product (IP); (4)Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of IP; (5)CYP3A4 strong inhibitor or strong inducer is used within 7 days prior to the first dose, or need to receive these drugs during the study period; (6)Traditional Chinese medicine and traditional Chinese medicine preparations with anti-tumor as indications and with adjuvant treatment of tumor is used within 7 days prior to the first dose, or need to receive these drugs during the study period; (7)Patients who are receiving drugs known to prolong QTc interval or may cause torsade de pointe and need to continue to receive these drugs during the study period; (8)The time from the treatment with any other investigational product or its analogue to the first dose does not exceed 5 half-lives of the drug or 14 days, whichever is longer; 9.Spinal cord compression; symptomatic and unstable brain metastases, except for those patients who have completed definitive therapy, are not on steroids, and have a stable neurological status for at least 4 weeks after completion of the definitive therapy and steroids. Patients who have received local radiotherapy for brain metastases can only be enrolled if the symptoms of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease Control Rate;OS; | — |
Countries
China
Contacts
Public ContactDing Guozheng
Anqing Municipal Hospital
Outcome results
None listed