Non Small Cell lung cancer
Conditions
Interventions
Furmonertinib Group:Furmonertinib 160mg Oral QD
Sponsors
JiangSu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1.Provide informed consent prior to any study specific procedures; 2.at least 18 years of age; 3.ECOG PS of 0 to 1 at screening with no clinically significant deterioration in the previous 2 weeks, life expectancy >=12 weeks; 4.Histologically or cytologically confirmed non-squamous Non-Small Cell Lung Cancer (NSCLC); 5.Locally advanced (clinical stage IIIB, IIIC) or metastatic Non-Small Cell Lung Cancer (NSCLC) (clinical stage IV) or recurrent Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy; 6.EGFR exon 21 L858R point mutation (L858R) issued or confirmed by Tier 3A hospital or a qualified testing institution (tissue or cytological specimens, including ARMS coBAS PCR); 7.Patients with asymptomatic and stable brain metastases can be included in the study,Steroid therapy is not allowed for 14 days before the start of study treatment. For CNS metastases Patients previously received local radiotherapy ,only when symptoms of brain metastases stable or at end of 14 days of radiotherapy can be enrolled ; 8.The patient has not received systemic anti-tumor therapy for advanced/metastatic non-small cell lung cancer, including standard chemotherapy, biological therapy, targeted therapy, immunotherapy, or experimental drug therapy before the initiation of study drug therapy; received adjuvant therapy or neoadjuvant therapy (chemotherapy and/or radiotherapy), if there is no progression within 6 months after treatment, admission is allowed; for patients who have received local therapy (radiotherapy or pleural infusion therapy), if the lesions are non-target lesions and are allowed to be enrolled; 9.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; 10.Adequate organ reserve function (bone marrow, liver and kidney function, coagulation function); 11.Fertile female subjects should use highly effective contraception at least 2 weeks before starting the study, pregnancy tests must be negative, and no ongoing breastfeeding prior to starting the study; 12.Male subjects should be willing to use effective barrier contraception (condoms); 13.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: Inclusion 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 and combined exon 19 deletion mutation (19Del), or exon 20 T790M mutation (T790M), or other rare mutations in EGFR (G719S, L816Q, S7618I mutations); 3.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; 4.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; 5.At the beginning of study treatment, any unresolved toxic reaction to prior treatment is present, which exceeds Grade 1 in accordance with Common Terminology Criteria for Adverse Events (CTCAE) (except for alopecia), and exceeds Grade 2 for prior platinum treatment-related neuropathy. 6.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 2 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 brain metastases are stable for 14 days or more after the end of radiotherapy; 7.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; 8.Patients with refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow study drugs, or previous colon cancer resection, etc. that hinder the full absorption of furmonertinib; 9.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; 10.Severe acute or chronic infections, including: Uncontrolled acute infection, active infection requiring systemic therapy or systemic antibiotic therapy within 2 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease Control Rate;PFS Rate at 18 months;Overall Survival; | — |
Countries
China
Contacts
Public ContactMeiqi Shi
JiangSu Cancer Hospital
Outcome results
None listed