[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06010329":3,"trial-entities:NCT06010329":184,"trial-summary:NCT06010329":188},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":38,"secondary_outcomes":42,"sex":87,"minimum_age":88,"maximum_age":89,"healthy_volunteers":90,"eligibility_criteria":91,"std_ages":95,"locations":98,"central_contacts":171,"overall_officials":181,"references":182,"see_also_links":183},"NCT06010329","TL-EGFR-2201","A Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC","A Multicenter, Open-label, Phase 2 Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC (Uncommon EGFR Mutations Only)","RECRUITING","2028-12","2026-04","2026-04-24","2023-12-27","Teligene US","INDUSTRY",true,"The main objective of the study will be to evaluate the efficacy of sutetinib maleate capsules in participants with locally advanced or metastatic non-small cell lung cancer NSCLC (uncommon EGFR mutations only).","Sutetinib is an investigational irreversible EGFR tyrosine kinase inhibitor. EGFR is a gene that makes a protein that is involved in cell growth and cell survival. Mutated (changed) forms of the EGFR gene and protein have been found in some types of cancer, including non-small cell lung cancer. These changes may cause cancer cells to grow and spread in the body. The purpose of this study is to explore how effective sutetinib maleate capsules are for the treatment of patients with locally advanced or metastatic NSCLC with uncommon EGFR mutations.",[19],"Non-small Cell Lung Cancer",[21,22,23,24],"Oncology","Sutetinib Maleate Capsule","Teligene","Cancer","INTERVENTIONAL","TREATMENT",[28],"PHASE2",{"count":30,"type":31},66,"ESTIMATED",[33],{"type":34,"name":22,"description":35,"armGroupLabels":36},"DRUG","Oral administration",[37],"Single arm, Open label",[39],{"measure":40,"timeFrame":41},"Objective Response Rate (ORR)","Pre-dose up to approximately 32 months post-dose",[43,45,47,49,51,53,55,57,61,64,67,69,71,73,75,77,79,81,83,85],{"measure":44,"timeFrame":41},"Duration of Response (DoR)",{"measure":46,"timeFrame":41},"Disease Control Rate (DCR)",{"measure":48,"timeFrame":41},"Progression Free Survival (PFS)",{"measure":50,"timeFrame":41},"Time to Tumor Progression (TTP)",{"measure":52,"timeFrame":41},"Time to Response (TTR)",{"measure":54,"timeFrame":41},"Time to Treatment Failure (TTF)",{"measure":56,"timeFrame":41},"Overall Survival (OS)",{"measure":58,"description":59,"timeFrame":60},"1-year Progression Free Survival","Ratio of participants who do not have objective tumor progression or have not died 1 year after the first dose of IP.","Pre-dose up to 1 year post-dose",{"measure":62,"description":63,"timeFrame":60},"1-year Survival","Ratio of surviving participants 1 year after the first dose of IP.",{"measure":65,"timeFrame":66},"Area Under The Curve (AUC) of Sutetinib Maleate Capsule","Pre-dose up to 24 hours post-dose",{"measure":68,"timeFrame":66},"Maximum Plasma Concentration (Cmax) of Sutetinib Maleate Capsule",{"measure":70,"timeFrame":66},"Minimum Plasma Concentration (Cmin) of Sutetinib Maleate Capsule",{"measure":72,"timeFrame":66},"Time to Peak Drug Concentration (Tmax) of Sutetinib Maleate Capsule",{"measure":74,"timeFrame":66},"Sutetinib Maleate Capsule half-life (T1\u002F2)",{"measure":76,"timeFrame":66},"Apparent Clearance (CL\u002Ff) of Sutetinib Maleate Capsule",{"measure":78,"timeFrame":66},"Volume of Distribution (Vz\u002FF) of Sutetinib Maleate Capsule",{"measure":80,"timeFrame":41},"Number of Participants Experiencing Adverse Events (AE)",{"measure":82,"timeFrame":41},"Number of Participants Experiencing Adverse Drug Reactions (ADR)",{"measure":84,"timeFrame":41},"Number of Participants Experiencing Serious Adverse Events (SAE)",{"measure":86,"timeFrame":41},"Number of Participants Experiencing Srious Adverse Reactions (SAR)","ALL","18 Years",null,false,{"inclusion":92,"exclusion":93,"raw_text":94},[],[],"Inclusion Criteria:\n\n1. Age 18 years old and above, male or female\n2. Histopathological and\u002For cytopathological confirmation of locally advanced or metastatic NSCLC\n3. Confirmation that the tumor harbors an uncommon epidermal growth factor receptor (EGFR) mutation (tumor tissue biopsy)\n4. At least one measurable lesion\n5. Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2\n6. A minimum life expectancy of \\> 3 months\n7. Adequate bone marrow reserve, hepatic, renal, and coagulation function\n\nOther inclusion criteria apply for participating in the study.\n\nExclusion Criteria:\n\n1. Participant ever used the epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR TKI) for anti-tumor therapy prior to enrollment (Cohort 1), or second generation EGFR TKI (Cohort 2)\n2. Any systemic anti-tumor therapy such as chemotherapy and radiation therapy (including curative radiotherapy or spinal radiotherapy portion \\>30%) used within 3 weeks prior to enrollment; immunotherapy within 4 weeks; any palliative radiotherapy for non-target lesions used to relieve symptoms and traditional Chinese medicines indicated for the tumor within 2 weeks prior to enrollment; Cohort 2: any EGFR TKIs within 5 half-lives.\n3. Use or intake of drugs or foods containing potent inhibitors or inducers of cytochrome P450 isozyme 3A4 (CYP3A4) within 14 days or 5 half-lives, whichever is the longer, prior to enrollment\n4. Surgical operation (excluding aspiration biopsy) of main organs or a significant injury within 4 weeks prior to enrollment\n5. Any unresolved toxicities from prior therapy greater than National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAEv5.0) Grade 1, at the time of screening except for alopecia\n6. Inability to swallow the study medication, any seriously (NCI-CTCAEv5.0 ≥ Grade 3) chronic gastrointestinal disorder, malabsorption syndrome or any other conditions with influence on gastrointestinal absorption\n7. Active central nervous system metastases\n8. Any active infection which has not been controlled at screening\n\nOther exclusion criteria apply for participating in the Study.",[96,97],"ADULT","OLDER_ADULT",[99,109,116,124,132,140,148,157,163],{"facility":100,"status":101,"city":102,"state":103,"zip":104,"country":105,"geoPoint":106},"Oncology Physicians Network Healthcare","WITHDRAWN","Glendale","California","91203","United States",{"lat":107,"lon":108},34.14251,-118.25508,{"facility":110,"status":8,"city":111,"state":103,"zip":112,"country":105,"geoPoint":113},"University of California San Diego Moores Cancer Center","La Jolla","92093",{"lat":114,"lon":115},32.84727,-117.2742,{"facility":117,"status":8,"city":118,"state":119,"zip":120,"country":105,"geoPoint":121},"Moffitt Cancer Center","Tampa","Florida","33612",{"lat":122,"lon":123},27.94752,-82.45843,{"facility":125,"status":8,"city":126,"state":127,"zip":128,"country":105,"geoPoint":129},"University Cancer & Blood Center (UCBC) - Athens","Athens","Georgia","30607",{"lat":130,"lon":131},33.96095,-83.37794,{"facility":133,"status":8,"city":134,"state":135,"zip":136,"country":105,"geoPoint":137},"Mission Cancer + Blood - Mission Cancer Foundation","Des Moines","Iowa","50309",{"lat":138,"lon":139},41.60054,-93.60911,{"facility":141,"status":101,"city":142,"state":143,"zip":144,"country":105,"geoPoint":145},"Norton Cancer Institute - Downtown","Louisville","Kentucky","40202",{"lat":146,"lon":147},38.25424,-85.75941,{"facility":149,"status":150,"city":151,"state":152,"zip":153,"country":105,"geoPoint":154},"Northwell Health","ACTIVE_NOT_RECRUITING","New Hyde Park","New York","11042",{"lat":155,"lon":156},40.7351,-73.68791,{"facility":158,"status":8,"city":152,"state":152,"zip":159,"country":105,"geoPoint":160},"Perlmutter Cancer Center - 34th Street","10016",{"lat":161,"lon":162},40.71427,-74.00597,{"facility":164,"status":8,"city":165,"state":166,"zip":167,"country":105,"geoPoint":168},"University of Texas MD Anderson Cancer Center","Houston","Texas","77030",{"lat":169,"lon":170},29.76328,-95.36327,[172,177],{"name":173,"role":174,"phone":175,"email":176},"Xiaoyang Xia","CONTACT","805-300-9373","Xiaoyang.xia@teligene.com",{"name":178,"role":174,"phone":179,"email":180},"Dawei Zhang","805-300-1019","david.zhang@teligene.com",[],[],[],{"nct_id":4,"conditions":185,"biomarkers":187},[186],"Lung Non-Small Cell Carcinoma",[],{"nct_id":4,"found":15,"summary":189,"prompt_version":89},{"design":190,"status":191,"heading":192,"summary":193,"follow_up":194,"word_count":195,"commitments":196,"compensation":197,"drugs_mentioned":198},"This is an interventional study with a planned enrollment of 66 participants. It is evaluating Sutetinib Maleate Capsule for non-small cell lung cancer.","completed","Sutetinib Maleate Capsule for Advanced NSCLC with Uncommon EGFR Mutations","This study is testing a drug called Sutetinib Maleate Capsule for people with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has specific uncommon changes (mutations) in the EGFR gene. Sutetinib Maleate Capsule is an investigational drug that works by blocking certain proteins (tyrosine kinase inhibitor) involved in cancer growth. Researchers want to see how well Sutetinib Maleate Capsule shrinks tumors (Objective Response Rate) over about 32 months. To join, you must be at least 18 years old, have NSCLC confirmed by a doctor, and your tumor must have an uncommon EGFR mutation. You also need to have at least one measurable tumor and a good general health score.","Participants will be followed for objective response rate from pre-dose up to approximately 32 months post-dose.",111,"Not specified in the trial record.","Not stated in the trial record.",[22]]