Befotertinib and Icotinib in Treatment-naive Patients With Advanced EGFR-Mutant Lung Cancer
- Conditions
- Non-Small Cell Lung Cancer
- Registration Number
- NCT05007938
- Lead Sponsor
- Betta Pharmaceuticals Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria:<br><br> - 18 years of age or older.<br><br> - Pathologically confirmed adenocarcinoma of the lung, with locally advanced or<br> metastatic disease and not amenable to curative surgery or radiotherapy (stage IIIB,<br> IIIC or IV disease based on the eighth edition of the American Joint Committee on<br> Cancer (AJCC) TNM classification). Patients with mixed histology are eligible if<br> adenocarcinoma is the predominant histology.<br><br> - Patients must be treatment-naive for locally advanced or metastatic NSCLC systemic<br> antitumor therapy. Prior adjuvant and neo-adjuvant therapy (except for EGFR-TKIs) is<br> permitted if have been completed at least 6 months prior to initiation of disease<br> progression.<br><br> - The tumour tissues harbour one of the two common EGFR mutations known to be<br> associated with EGFR-TKI sensitivity (Ex19del, L858R),either alone or in combination<br> with other EGFR mutations, excluding co-mutation of Ex19del and L858R,assessed by<br> central laboratory.<br><br> - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.<br><br> - Predicted survival = 3 months.<br><br> - At least 1 measurable tumor lesion without radiotherapy as per RECIST v1.1.<br><br> - Agree to use effective contraception during the study period and for at least 3<br> months after completion of the study treatment.<br><br> - Provision of informed consent prior to any study procedure.<br><br>Exclusion Criteria:<br><br> - Combined with other malignancy(except for clinically cured in situ cervix carcinoma,<br> basal cell or squamous epithelial skin cancer,thyroid papillary carcinoma).<br><br> - Prior treatment with any EGFR-TKIs.<br><br> - Prior treatment with any systemic antitumor therapy for locally advanced or<br> metastatic NSCLC.<br><br> - Previous traditional chinese medicine with an antitumor indication within 2 weeks<br> before the first dose of study drug.<br><br> - Previous major surgery within 4 weeks before the first dose of study drug,or planing<br> to have major surgery during study.<br><br> - Symptoms or signs worsened within 2 weeks before the first dose of study drug.<br><br> - Any unresolved toxicities from prior treatment greater than NCI CTCAE v4.03 grade 2<br> or higher.<br><br> - Spinal cord compression,symptomatic or unstable central nervous system (CNS)<br> metastases that require the use of steroids .Patients who have a stable CNS status<br> for at least 4 weeks before treatment will be allowed to join the study.<br><br> - Any clinical evidence of serious or uncontrolled systemic disease,including<br> uncontrolled hypertension after drug treatment,active bleeding diatheses, previous<br> or present thrombus,uncontrolled cardiovascular and cerebrovascular diseases.<br><br> - Active infection including hepatitis B,hepatitis C,syphilis and human<br> immunodeficiency virus (HIV).<br><br> - Mean resting corrected QT interval (QTcF) =450 msec,obtained from 3 ECGs or any<br> clinically important abnormalities in rhythm,conduction, morphology of resting ECG<br> or left ventricular ejection fraction (LVEF) = 50%,etc.<br><br> - Previous history of interstitial lung disease(ILD),drug-induced interstitial lung<br> disease,history of radiation-induced pneumonia requiring hormone therapy,or clinical<br> evidence of active interstitial lung disease.<br><br> - Any instance that affects the patient's ability to swallow drug or oral<br> malabsorption.<br><br> - Occur any laboratory indicator abnormalities as follow:<br><br> - absolute neutrophil count(ANC)<1,500/mcL<br><br> - platelets<100,000/mcL<br><br> - hemoglobin<9.0 g/dL<br><br> - AST/ALT>2.5 times the upper limit of normal (ULN)or >5 times the ULN in the<br> presence of liver metastases<br><br> - total bilirubin(TBIL)>1.5 times the ULN if no liver metastases or > 3 times the<br> ULN in the presence of liver metastases<br><br> - serum creatinine(SCr) >1.5 times the ULN or creatinine clearance =50 mL/min.<br><br> - Patients with a known allergy or delayed hypersensitivity reaction to the any<br> component of study drugs or their excipients.<br><br> - Within 1 week before the first dose of study drug currently receiving or need<br> concomitant medications known to be potent inhibitors or inducers of CYP3A,<br> CYP2D6,CYPC8 and CYP2C19,sensitive substrate of CYP3A and CYP2C9.<br><br> - Within 1 week before the first dose of study drug ongoing use of warfarin.<br><br> - Previous therapeutic clinical trial within 4 weeks before the first dose of study<br> drug.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR)
- Secondary Outcome Measures
Name Time Method Duration of response(DOR);Disease control rate(DCR);Progression-free survival(PFS);Intracranial objective response rate(iORR);Overall survival (OS);Adverse event(AE)