[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"egfr\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:egfr":40},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,56,94,120,147,172,209,231,257],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":41,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100628495","phase-1-a-phase-1-study-of-epi-326-in-egfr-mutant-nsclc-and-hnscc-100628495",false,"NCT07462377","A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and HNSCC","A First-in-Human, Open-label, Multicenter, Phase 1 Study of EPI-326 in Patients With Epidermal Growth Factor Receptor-Mutant Non-small Cell Lung Cancer and Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Participant has a life expectancy \\> 12 weeks at Day 1.\n2. Participant has an ECOG performance status of 0-2.\n3. Participant has pathologically confirmed NSCLC or HNSCC.\n\n   o For NSCLC: the tumor harbors any documented EGFR mutation, insertion, or deletion.\n4. Participant has locally advanced or metastatic NSCLC or HNSCC.\n5. Participant has adequate organ function\n\nExclusion Criteria:\n\n1. Participant has history of uncontrolled illness.\n2. Participant has symptomatic brain metastases.\n3. Participant has a diagnosis of any secondary malignancy within 3 years prior to enrollment, except for those patients treated with curative intent and no evidence of active disease.","ALL","18 Years",{"count":19,"type":20},110,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","A phase 1 study to determine the safety, tolerability, PK, PD, and preliminary anti-tumor activity of ascending doses of EPI-326 administered to patients with locally advanced or metastatic HNSCC and to patients with any documented EGFR-mutant locally advanced or metastatic NSCLC.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40],"Epidermal Growth Factor","Epidermal Growth Factor Receptor","Epidermal Growth Factor Receptor Gene Mutation","Non Small Cell","Non Small Cell Lung","Non Small Cell Lung Cancer","Head and Neck","Head and Neck Cancer","Head and Neck Cancers","Head and Neck Squamous Cell Cancer","Head and Neck Squamous Cell Carcinoma","Head and Neck Squamous Cell Carcinoma HNSCC","NSCLC (Non-small Cell Lung Cancer)","HNSCC","EGFR",[36,39,28,40,31,42],"NSCLC","RECRUITING","2026-06-08",{"date":46,"type":47},"2026-06-10","ACTUAL",{"date":49,"type":47},"2026-03-31",{"date":51,"type":20},"2029-07",{"name":53,"class":54},"EpiBiologics","INDUSTRY",6,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":66,"phases":4,"briefSummary":67,"conditions":68,"keywords":76,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":93},"100636247","observational-multicenter-study-in-patients-receiving-chemotherapy-and-amivantamab-for-metastatic-non-small-cell-lung-cancer-100636247","NCT07563205","Observational Multicenter Study in Patients Receiving Chemotherapy and Amivantamab for Metastatic Non-small Cell Lung Cancer","Observational Multicenter Study in Patients Receiving Chemotherapy and Amivantamab for Metastatic Non-small Cell Lung Cancer as Part of an Early Access Program","OMAE","Inclusion Criteria:\n\n* Patient over 18 years old\n* Cohort A: Patient with metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 20 insertion treated with amivantamab-platimum based chemotherapy via an early access program in first line setting.\n* Cohort B: Patient with metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 19 or 21 treated with amivantamab-platimum based chemotherapy post osimertinib (with or without chemotherapy) via an early access program.\n* Patient covered by the French National Health Insurance system or by an approved third-party payer\n* Patient who does not object to the collection of their personal data for research purposes (an information sheet will be provided to all living participants; for deceased participants, documented non-opposition in the medical record is not required)\n\nExclusion Criteria:\n\n* Patient placed under legal guardianship or subject to a protective legal measure\n* Patient who explicitly refuses the collection or use of their personal data for research purposes\n* Patient not enrolled, managed, or followed at the investigating site by a qualified site investigator",{"count":65,"type":20},100,"OBSERVATIONAL","The purpose of this observational study is to understand how well a treatment combining chemotherapy and amivantamab works in real life, and how safe it is, in adults with metastatic non-small cell lung cancer (NSCLC) who have certain EGFR gene mutations.\n\nThe study includes two groups of people:\n\n* Group A: people with an EGFR exon 20 insertion who receive amivantamab together with platinum-based chemotherapy as their first treatment, through an early access program.\n* Group B: people with an EGFR exon 19 or exon 21 mutation who receive amivantamab with platinum-based chemotherapy after having been treated with osimertinib (with or without chemotherapy), also through an early access program.\n\nThe main question the study wants to answer is:\n\nHow long can the combination of amivantamab and chemotherapy keep the cancer from coming back or getting worse in these two groups of people?\n\nPeople already receiving amivantamab and chemotherapy for NSCLC through an early access program may be included. They will continue to be followed by their usual oncologist as part of their normal medical care. The study will simply collect their medical information from March 21, 2024 to October 21, 2025.\n\nNo extra tests or procedures are required. This is an observational study, carried out by the GFPC and partner centers in France.",[69,70,71,72,42,40,73,74,75],"Non-Small Cell Lung Cancer","Non Small Cell Lung Cancer Metastatic","Non Small Cell Lung Cancer NSCLC","Non Small Cell Lung Carcinoma","EGFR Exon 20 Insertion Mutation","EGFR Exon 19 Deletion Mutation","EGFR Exon 21 Mutation",[77,78,79,80,81,82,42],"Lung Cancer","Non Small Cell lung cancer","Metastatic lung cancer","EGFR Exon 20","EGFR Exon 19","EGFR Exon 21","2026-04-24",{"date":85,"type":47},"2026-05-01",{"date":87,"type":47},"2025-11-19",{"date":89,"type":20},"2027-11-19",{"name":91,"class":92},"GFPC Investigation","OTHER",16,{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":21,"phases":103,"briefSummary":104,"conditions":105,"keywords":108,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":119},"100589898","phase-1-safety-and-preliminary-efficacy-of-vir-5525-and-vir-5525--pembrolizumab-in-participants-with-locally-advanced-or-metastatic-solid-tumors-100589898","NCT06960395","Safety and Preliminary Efficacy of VIR-5525 and VIR-5525 + Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors","A Phase 1, First-in-Human Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5525 Alone and in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\nI 01. Are ≥ 18 years of age, or at the country's legal age of majority of the legal adult age is \\>18 years, at the time of signing the ICF.\n\nI 02. Have an ECOG performance status of 0 to 1.\n\nI 03. Have a life expectancy of at least 12 weeks.\n\nI 04. Have histological, pathological, or cytological confirmation of disease type that is unresectable, locally advanced, or metastatic.\n\nI 05. Have measurable disease per RECIST v1.1 as assessed by the local site investigator\u002Fradiology. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n\nI 06. Have diseases under study, lines of therapy, and biomarker status, as follows:\n\nHave one of the following:\n\n• (Parts 1 and 3): NSCLC (nonsquamous or squamous histology), CRC, HNSCC, or CSCC.\n\nNote: Participants with nasopharyngeal tumors are eligible. Note: Participants with upper esophageal or salivary gland tumors are not eligible.\n\nOR\n\n• Have a solid tumor with EGFR amplification (as previously determined locally with an analytically validated assay in a certified testing laboratory).\n\nHave no available standard systemic therapy; or standard therapy is intolerable, not effective, or not accessible; or participant has refused standard therapy.\n\nExclusion Criteria:\n\nE 01. Are a WOCBP with a positive serum or urine pregnancy test within 72 hours prior to treatment.\n\nE 02. Have acute or chronic infections, including the following:\n\n* Acute or chronic active Epstein-Barr virus (EBV) infection (Exception: asymptomatic EBV-positive participants are still eligible)\n* Chronic active EBV disease defined as a chronic illness lasting at least 6 months, an increased EBV level in either the tissue or the blood, and lack of evidence of a known underlying immunodeficiency\n* History of hepatitis B infection (defined as hepatitis B surface antigen \\[HBsAg\\] reactive) or known active hepatitis C virus (HCV) infection (defined as HCV \\[HCV RNA; qualitative\\] is detected)\n* History of HIV infection. No HIV testing is required unless mandated by the local health authority.\n* Active infection requiring systemic therapy within 14 days of Cycle 1 Day 1\n* Known positive COVID-19 test result at screening (Exception: If follow-up test is negative, participants may be eligible if asymptomatic and upon consultation with medical monitor)\n\nE 03. Have a concomitant medical or inflammatory condition that may increase the risk of toxicity to VIR-5525 or pembrolizumab, per the investigator\n\nE 04. Have a QT interval corrected by Fridericia's method (QTcF) that is \\>480 ms\n\nE 05. Have received prior systemic anti-cancer therapy, including investigational agents, within 5 half-lives prior to first dose of study intervention. For drugs with a long t1\u002F2, such as mAbs, or for drugs for which the t1\u002F2 is not known, the last dose should not have been within 28 days prior to first dose of study intervention.\n\nNote: If the participant has had major surgery, the participant must have recovered adequately from the procedure and\u002For any complications from the surgery prior to starting study intervention.\n\nE 06. Have received prior radiotherapy within 2 weeks of start of study intervention Note: Participants must have recovered from all radiation-related toxicities to Grade ≤1 or baseline, must not require corticosteroids, and must not have had radiation pneumonitis.\n\nException: External beam radiotherapy, including palliative external radiation, is allowed.\n\nA 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.\n\nThe above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.",{"count":102,"type":20},450,[23],"This Phase 1, first-in-human (FIH), dose-escalation and dose-expansion study is designed to evaluate the safety, PK, and preliminary anti-tumor activity of VIR-5525 as a monotherapy and in combination with pembrolizumab in participants with solid tumors that are known to express EGFR.\n\nThe study will be conducted in the following 4 parts:\n\n* Part 1: VIR-5525 monotherapy dose escalation\n* Part 2: VIR-5525 monotherapy dose expansion\n* Part 3: VIR-5525 plus pembrolizumab dose escalation\n* Part 4: VIR-5525 plus pembrolizumab dose expansion",[106,107,40],"Solid Tumor Malignancies","EGFR Positive Solid Tumors",[109],"VIR-5525","2026-04-10",{"date":112,"type":47},"2026-04-13",{"date":114,"type":47},"2025-07-22",{"date":116,"type":20},"2029-08",{"name":118,"class":54},"Vir Biotechnology, Inc.",4,{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":128,"enrollmentInfo":129,"targetDuration":4,"studyType":21,"phases":131,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":146},"100592385","phase-2-trilaciclib-in-patients-receiving-sacituzumab-tirumotecan-for-egfr-mutated-advanced-non-small-cell-lung-cancer-nsclc-100592385","NCT06992739","Trilaciclib in Patients Receiving Sacituzumab Tirumotecan for EGFR-mutated, Advanced Non-Small Cell Lung Cancer (NSCLC)","A Prospective, Single-arm Phase II Trial of Trilaciclib Administered Prior to Sacituzumab Tirumotecan in Patients With EGFR-mutated, Advanced Non-Small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors（PROTECT-2）","PROTECT-2","Inclusion Criteria:\n\n1. Age range: 18-75 years old; No gender restrictions;\n2. ECOG PS score 0-1;\n3. Expected survival time ≥ 3 months;\n4. Patients with locally advanced or metastatic EGFR mutant non-small cell lung cancer diagnosed by histological or cytological examination, who have failed third-generation EGFR-TKI treatment and have experienced up to second-line EGFR-TKI treatment failure;\n\n   1. Patients who have only progressed with 1-2 generations of EGFR-TKI treatment need to undergo third-generation EGFR-TKI treatment;\n   2. If patients receive third-generation EGFR-TKI during neoadjuvant and\u002For postoperative adjuvant therapy and progress to metastatic or locally advanced disease more than 6 months after the last dose, they need to receive third-generation EGFR-TKI treatment again before they can participate in this study;\n   3. If patients receive third-generation EGFR-TKI during neoadjuvant and\u002For postoperative adjuvant therapy and progress to metastatic or locally advanced disease within 6 months after the last dose, they can directly participate in this study;\n   4. Imaging disease progression was recorded during or after the recent first-line treatment process.\n5. There must be at least one measurable lesion that meets the RECIST 1.1 criteria;\n6. The main organ functions well and meets the following standards:\n\n   Blood routine examination (without blood transfusion or correction with hematopoietic stimulating factor drugs within 14 days): hemoglobin (Hb) ≥ 90g\u002FL; Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL; Platelet count (PLT) ≥ 80 × 109\u002FL; Biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastasis); Serum total bilirubin (TBIL) ≤ 1.5 × ULN (Gilbert syndrome subjects, ≤ 3×ULN）； Serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance rate ≥ 60mL\u002Fmin; Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤ 1.5 × ULN;\n7. The subject must recover from all toxic reactions (except hair loss) of previous treatment to ≤ level 1 (evaluated based on CTCAE 5.0 criteria);\n8. Women: All women with potential fertility must have a negative serum pregnancy test result during the screening period, and must take reliable contraceptive measures from signing the informed consent form until 3 months after the last dose;\n9. Participants voluntarily participate in this study, understand and sign the informed consent form.\n\nExclusion Criteria:\n\n1. History of myeloid leukemia, myelodysplastic syndrome, or accompanying sickle cell disease;\n2. Symptomatic CNS metastases and\u002For leptomeningeal diseases that require immediate radiotherapy or steroid treatment;\n3. Have undergone surgery or radiation therapy within 4 weeks prior to the administration of the first dose of the study drug;\n4. Clinical symptoms or diseases of the heart that have not been well controlled, such as: (1) NYHA grade 2 or above heart failure; (2) Unstable angina pectoris; (3) Have experienced myocardial infarction within 6 months; (4) Patients with clinically significant supraventricular or ventricular arrhythmias that require treatment or intervention;\n5. History of interstitial lung disease, slow progressive dyspnea and dry cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary allergic pneumonia, or multiple allergic or peripheral arterial diseases (such as claudication, Leo Buerger's disease).\n6. Patients who have received hematopoietic stem cell or bone marrow transplantation in the past;\n7. Patients who need to receive radiation therapy at the same time;\n8. Those who are known to have a history of allergies to the components of this drug regimen;\n9. Pregnant or lactating women;\n10. The researcher believes that the patient is not suitable to participate in any other circumstances of this study.","75 Years",{"count":130,"type":20},49,[132],"PHASE2","This study is a prospective, single arm phase II clinical trial aimed at patients with advanced non-small cell lung cancer resistant to EGFR-TKI. The aim is to evaluate the efficacy and safety of trilaciclib in bone marrow protection before monotherapy with sacituzumab tirumotecan.\n\nPatients with advanced non-small cell lung cancer resistant to EGFR-TKI, after signing informed consent, will be screened for eligible subjects who meet the inclusion criteria. Prior to receiving treatment with sacituzumab tirumotecan, they will be treated with trilaciclib until disease progression or intolerable toxicity occurs.\n\nRecord the dynamic changes of whole blood cell count; Hematological toxicity, including febrile neutropenia and associated infections; Transfusion of blood products and supplementation of hematopoietic raw materials. Perform tumor imaging evaluation according to RECIST 1.1. Baseline imaging examination should be conducted within 21 days prior to the first administration, and tumor imaging evaluation shall be conducted every 6 weeks (± 7 days) from the first study drug administration, or the frequency of imaging evaluation may be increased when there are clinical indications. Subjects who terminate the study drug treatment due to intolerable toxicity or other non disease progression reasons continue to receive tumor evaluation follow-up until disease progression, withdrawal from the study, or death (whichever occurs earliest).\n\nAfter the screening period and one cycle of treatment, subjects may choose to undergo whole-body PET\u002FCT imaging for exploratory analysis.",[135,40,136],"NSCLC (Advanced Non-small Cell Lung Cancer)","Myelosuppression","2026-04-09",{"date":139,"type":47},"2026-04-14",{"date":141,"type":47},"2025-12-08",{"date":143,"type":20},"2027-12",{"name":145,"class":92},"The First Affiliated Hospital of Xiamen University",1,{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":21,"phases":156,"briefSummary":158,"conditions":159,"keywords":160,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":171},"100589560","phase-3-firmonertinib-versus-platinum-based-chemotherapy-as-first-line-treatment-for-nsclc-with-egfr-pacc-or-egfr-l861q-mutation-100589560","NCT06956001","Firmonertinib Versus Platinum Based Chemotherapy as First-line Treatment for NSCLC With EGFR PACC or EGFR l861q Mutation","A Phase III, Randomized, Multicentre, Open Label Study to Assess the Efficacy and Safety of Firmonertinib Versus Platinum Based Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients With EGFR PACC Mutation or EGFR l861q Mutation","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form (ICF).\n2. Age ≥18 years at the time of ICF signing.\n3. At least one measurable lesion per RECIST v1.1, meeting the following:\n\n   * No prior local therapy (e.g., radiotherapy)\n   * Not used for biopsy during screening\n4. Histologically\u002Fcytologically confirmed non-squamous NSCLC, classified as:\n\n   * Locally advanced (Stage IIIB\u002FIIIC, unsuitable for curative surgery and\u002For definitive chemoradiotherapy)\n   * Metastatic (Stage IV) (Based on UICC\u002FAJCC 8th edition TNM staging)\n5. Agreement to provide:\n\n   * Recent tumor tissue (from untreated lesions)\n   * Blood samples\n   * Central lab-confirmed EGFR PACC or L861Q mutation (If tumor tissue is unavailable due to inaccessible lesions, sponsor consultation is required.)\n6. No prior systemic therapy for advanced\u002Fmetastatic NSCLC.\n\n   * Allowed if: Prior (neo)adjuvant\u002Fdefinitive chemoradiotherapy completed ≥12 months before recurrence\u002Fprogression\n7. ECOG performance status 0-1.\n8. Life expectancy ≥12 weeks.\n9. Adequate bone marrow\u002Forgan function within 14 days before treatment (no transfusion\u002FG-CSF within 2 weeks prior).\n10. Women of childbearing potential (WOCBP):\n\n    * Abstinence or contraception use\n    * No egg donation\n11. Non-sterilized males:\n\n    * Abstinence or contraception use\n    * No sperm donation\n12. CNS metastases allowed if protocol-specified criteria are met.\n\nExclusion Criteria:\n\n1. Histologically\u002Fcytologically confirmed tumor with \\>10% neuroendocrine carcinoma, sarcomatoid carcinoma, or squamous cell components.\n2. Known ALK-positive, ROS1-positive, RET fusion-positive, NTRK fusion-positive, BRAF V600E mutation, MET exon 14 skipping mutation, or other targetable alterations with approved therapies.\n3. Prior treatments including:\n\n   1. Systemic anti-tumor therapy for advanced\u002Fmetastatic NSCLC (e.g., chemotherapy\u002Ftargeted\u002Fimmunotherapy). Neoadjuvant\u002Fadjuvant therapy exceptions per Inclusion Criterion #6.\n   2. \\>30 Gy thoracic radiotherapy within 6 months or non-thoracic radiotherapy within 4 weeks prior to first dose (brain radiotherapy exceptions per Inclusion Criterion #12).\n   3. Any prior EGFR-targeted therapy (including investigational EGFR-TKIs, mAbs, bispecific antibodies, etc.).\n   4. Strong CYP3A4 inhibitors within 7 days or inducers within 21 days prior to first dose.\n   5. Anticancer traditional Chinese medicines within 2 weeks prior to first dose.\n   6. Non-specific immunomodulators (e.g., interferon, IL-2, thymosin) within 2 weeks prior to first dose.\n   7. Major trauma\u002Fsurgery within 4 weeks prior to treatment initiation.\n4. Clinically significant gastrointestinal abnormalities, including:\n\n   * Moderate\u002Fsevere atrophic gastritis\n   * GI obstruction\u002Fperforation\n   * Chronic diarrhea\u002Fshort bowel syndrome\n   * Major upper GI surgery (e.g., gastrectomy)\n   * Inflammatory bowel disease (Crohn's\u002Fulcerative colitis) or active intestinal inflammation\n   * Inability to swallow tablets\n5. Uncontrolled systemic diseases.\n6. Severe acute\u002Fchronic infections.\n7. Interstitial lung disease (ILD)\u002Fnon-infectious pneumonia:\n\n   * History requiring clinical intervention\n   * Current presence\n   * Suspicious imaging findings unresolved at screening\n8. Clinically significant cardiovascular dysfunction (active or history).\n9. Tumor invasion of critical adjacent structures (heart\u002Fesophagus\u002FSVC etc.) with high bleeding\u002Ffistula risk. Exceptions may be considered if investigator assesses minimal risk.\n10. Pulmonary comorbidities causing severe impairment, including:\n\n    1. Baseline lung diseases (e.g., pulmonary embolism \\[≤3 months\\], severe asthma\u002FCOPD\u002Frestrictive disease)\n    2. Autoimmune\u002Fconnective tissue disorders with pulmonary involvement (e.g., rheumatoid arthritis, sarcoidosis)\n11. Residual toxicity \\>Grade 1 (per NCI CTCAE v5.0) from prior anticancer therapy (except alopecia\u002Fneuropathy).\n12. Concurrent malignancies except:\n\n    * Cured localized skin cancers (BCC\u002FSCC), superficial bladder cancer, cervical\u002Fbreast DCIS, or papillary thyroid cancer\n    * Other malignancies cured by radical therapy ≥3 years prior\n13. Pregnancy\u002Flactation or planned pregnancy within 6 months post-treatment.\n14. Inability to comply with study procedures\u002Ffollow-up.\n15. Known hypersensitivity to furmonertinib or excipients.\n16. History of allergic reactions to pemetrexed\u002Fcisplatin\u002Fcarboplatin.\n17. Other exclusionary per investigator judgment, including:\n\n    * Alcohol\u002Fdrug abuse\n    * Severe comorbidities (including psychiatric) requiring treatment\n    * Critical laboratory abnormalities\n    * Social\u002Ffamilial factors compromising safety\u002Fdata collection",{"count":155,"type":20},300,[157],"PHASE3","This study is a randomized, open, multicenter phase III clinical study, which aims to evaluate the efficacy and safety of firmonertinib mesylate compared with platinum based chemotherapy for patients with locally advanced or metastatic NSCLC who have not been treated with systemic antitumor therapy and carry EGFR PaCC mutation or EGFR l861q mutation.\n\nEligible patients were stratified by EGFR mutation type and CNS metastasis at the time of enrollment. Approximately 300 patients would be randomly assigned 1:1 to receive either firmonertinib mesylate (240mg, orally on an empty stomach daily) or platinum containing dual agent chemotherapy.",[40,135],[161],"firmonertinib","2026-02-10",{"date":164,"type":47},"2026-02-12",{"date":166,"type":47},"2024-11-19",{"date":168,"type":20},"2028-07",{"name":170,"class":54},"Allist Pharmaceuticals, Inc.",2,{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":21,"phases":181,"briefSummary":183,"conditions":184,"keywords":190,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":146},"100597781","kidney-protective-intervention-with-salt-substitute-after-kidney-tumor-surgery-100597781","NCT07062952","Kidney-protective Intervention With Salt Substitute After Kidney Tumor Surgery","Kidney-protective Intervention With Salt Substitute After Kidney Tumor Surgery: a Single-center Randomized Controlled Study(KISS Study)","Inclusion Criteria:\n\n* Participants must meet all of the following criteria:\n\n  1. Voluntary participation with signed informed consent from both the primary participant and all cohabiting family members, with commitment to study procedures and follow-up;\n  2. Age ≥18 years at enrollment (when signing informed consent), any gender;\n  3. Diagnosed kidney tumor patients who underwent radical nephrectomy or partial nephrectomy (no restrictions on surgical approach);\n  4. Preoperative eGFR \\>60 ml\u002Fmin\u002F1.73m² (calculated by CKD-EPI equation);\n  5. Serum potassium \\\u003C4.8 mmol\u002FL;\n  6. Predominantly home-based dietary habits (\\>90% meals prepared at home, assessed via self-report);\n  7. Normal contralateral renal function at screening;\n  8. Normal cardiopulmonary and hepatic function:\n\nExclusion Criteria:\n\n* Participants will be excluded if they meet any of the following:\n\n  1. Participant or cohabiting family members currently using potassium-sparing diuretics or potassium supplements, or prior use of salt substitutes;\n  2. Post-discharge eGFR \\\u003C45 ml\u002Fmin\u002F1.73m² without significant fluctuation;\n  3. Comorbid chronic kidney diseases (e.g., diabetic nephropathy, lupus nephritis);\n  4. Preoperative history of urinary tract obstruction;\n  5. Cohabiting family member(s) with CKD (eGFR \\\u003C45 ml\u002Fmin\u002F1.73m²);\n  6. Planned postoperative nephrotoxic medications (e.g., anti-neoplastic agents, immunotherapy);\n  7. Uncontrolled diabetes (HbA1c ≥12%);\n  8. Uncontrolled hypertension (seated SBP ≥180 mmHg or DBP ≥110 mmHg), symptomatic hypotension (SBP \\\u003C90 mmHg), or clinically evident hypovolemia;\n  9. Preoperative proteinuria (≥1+ on dipstick);\n  10. Severe cardiovascular disease (NYHA Class III-IV), gastrointestinal obstruction, or hyperkalemia history;\n  11. BMI \\\u003C18.5 kg\u002Fm² or \\>30 kg\u002Fm²;\n  12. Participation in another clinical trial ≤30 days before randomization or concurrently;\n  13. Communication barriers or anticipated non-adherence;\n  14. Structural\u002Ffunctional urological abnormalities (e.g., duplicated kidneys, polycystic kidneys, renal artery stenosis, stones, BPH) or indwelling catheters;\n  15. Prior radiotherapy\u002Fablation\u002Fsurgery on the contralateral kidney;\n  16. Life expectancy \\\u003C6 months (e.g., metastatic renal carcinoma).",{"count":180,"type":20},200,[182],"NA","This clinical trial is an open-label, randomized controlled study designed to evaluate the efficacyand safety of salt substitutes in protecting renal function after kidney tumor surgery, aiming toprovide dietary renal protection strategies for postoperative kidney tumor patients. lt will alsoassess the feasibility of salt substitute intervention. The primary research questions are:\n\n1. Does a salt substitute diet significantly improve estimated glomerular filtration rate (eGFR) compared to a regular salt diet in postoperative kidney tumor patients?\n2. What is the safety profile of salt substitute intervention in postoperative kidney tumor patients?\n3. What is the compliance rate among postoperative kidney tumor patients using saltsubstitutes?\n4. ls the salt substitute intervention feasible?\n\nResearchers will compare the intervention group (salt substitute diet) with the control group (regular salt diet) to determine whether salt substitutes effectively improve postoperative eGFR in kidney tumor patients.\n\nParticipants will be required to:\n\n1. Consume salt substitutes or regular salt daily while strictly adhering to WHO-recommendedsalt intake levels for 1 year.\n2. Undergo scheduled baseline assessments at 1, 3, 6, and 12 months post-surgery, with 24-hoururine tests at months 1 and 6 to evaluate compliance.\n3. Receive regular monitoring of blood electrolytes, eGFR, and other renal function indicators.\n4. Document any adverse events or health status changes during the study period.",[185,186,187,188,189],"Kidney Tumors","CKD","Salt Substitute","Nephrectomy","eGFR",[191,186,192,193,189,194,195,196,197,198,199],"kidney tumor","Salt substitute","nephrectomy","kidney protection","kidney function","open-label","randomized controlled trial","Renal function compensation","CKD with clinical significance","2025-12-07",{"date":202,"type":47},"2025-12-15",{"date":204,"type":47},"2025-04-24",{"date":206,"type":20},"2027-12-31",{"name":208,"class":92},"Jinling Hospital, China",{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":21,"phases":218,"briefSummary":219,"conditions":220,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":171},"100606895","phase-2-sequential-chemotherapy-with-befotertinib-in-non-small-cell-lung-cancer-nsclc-patients-with-resistance-to-third-generation-egfr-tki-100606895","NCT07181499","Sequential Chemotherapy With Befotertinib in Non-Small Cell Lung Cancer (NSCLC) Patients With Resistance to Third-Generation EGFR-TKI","A Study Evaluating the Efficacy and Safety of Pemetrexed Combined With Platinum-Based Chemotherapy Followed by Befotertinib in Patients With Non-Small Cell Lung Cancer After Third-Generation EGFR TKI Resistance","Inclusion Criteria:\n\n1. Age ≥18 years;\n2. Histologically or cytologically confirmed advanced or metastatic non-squamous NSCLC; and prior resistance to third-generation EGFR TKIs, with EGFR-sensitive mutations confirmed via tissue or blood samples (defined as: 19 Del or 21 L858R);\n3. Exclusion of small cell lung cancer (SCLC) or squamous cell carcinoma (SqCC) transformation, and known NSCLC with clear targetable mutations for targeted therapy, such as HER2, MET amplification (GCN ≥ 5), KRAS G12C mutation, BRAF V600E mutation, RET fusion mutation, ALK fusion mutation, NTRK fusion mutation, etc.;\n4. ECOG performance status (PS) score of 0-2;\n5. Life expectancy of at least 12 weeks;\n6. Ability to swallow oral medications;\n7. Adequate organ system function, defined as follows and determined based on investigator judgment:\n\n   1. Absolute neutrophil count (ANC) ≥ 1.5 x 10⁹\u002FL\n   2. Platelets ≥ 100 x 10⁹\u002FL;\n   3. Hemoglobin ≥ 9 g\u002FdL (≥ 90 g\u002FL). Note: Blood transfusions are permitted to achieve the required hemoglobin level;\n   4. Total bilirubin ≤ 1.5 times the upper limit of normal (ULN);\n   5. If no liver metastases: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; if liver metastases present: ≤ 5 × ULN;\n   6. Creatinine ≤1.5 × ULN. If ≥1.5 × ULN, patients remain eligible if the Cockcroft-Gault-calculated creatinine clearance ≥50 mL\u002Fmin (0.83 mL\u002Fs);\n8. Female subjects of childbearing potential must have a negative serum pregnancy test within 3 days prior to study drug initiation and agree to use a medically approved highly effective contraceptive method (e.g., intrauterine device, oral contraceptives, or condoms) during the study and for 3 months after the last study drug administration; Male subjects with female partners of childbearing potential must be surgically sterilized or agree to use an effective method of contraception during the study period and for 3 months after the last study dose.\n9. Voluntarily agree and be capable of adhering to the trial and follow-up procedures.\n10. Be able to understand the nature of the trial and complete the written informed consent form.\n\nExclusion Criteria:\n\n1. Rare EGFR mutations;\n2. Prior treatment with pemetrexed and platinum-based chemotherapy regimens;\n3. Advanced and\u002For symptomatic brain metastases (measurable or non-measurable) and\u002For leptomeningeal metastases;\n4. Active hepatitis B (serum HBV DNA ≥10⁴ copies\u002FmL \\[i.e., 20,000 IU\u002FmL\\]), hepatitis C virus antibody positive, HIV antibody positive, or treponema pallidum antibody positive;\n5. Women of childbearing potential with a positive serum pregnancy test within 7 days prior to treatment initiation, pregnant or lactating women, or male and female subjects not using effective contraception or planning pregnancy during treatment and for 3 months post-treatment;\n6. Patients who used or require concomitant use of the following drugs within 14 days prior to the first dose or during treatment: drugs associated with QTc prolongation and\u002For risk of torsades de pointes ventricular tachycardia; strong CYP3A inhibitors or inducers;\n7. Patients who underwent major surgery or immunotherapy within 4 weeks prior to the first dose; patients who received radiotherapy within 2 weeks prior to the first dose.\n8. Imaging (CT or MRI) demonstrating tumor invasion of major vessels, or a high likelihood of tumor invasion into critical vessels causing fatal hemorrhage during the study period;\n9. History of interstitial lung disease, drug-induced interstitial disease, or any clinically evident active interstitial lung disease; presence of idiopathic pulmonary fibrosis identified on baseline CT scan;\n10. Other severe acute or chronic medical conditions, including uncontrolled diabetes, medical or psychiatric disorders, or laboratory abnormalities, that in the investigator's judgment may increase study-related risks or interfere with interpretation of study results;\n11. Other conditions deemed by the investigator to be unsuitable for participation in this trial.",{"count":217,"type":20},28,[132],"Non-small cell lung cancer (NSCLC) accounts for over 85% of lung cancers. Approximately 30-40% of East Asian adenocarcinoma patients harbor EGFR mutations. Third-generation EGFR-TKIs achieve a median PFS of about 20 months as first-line therapy, but resistance eventually develops. Studies like MARIPOSA-2 confirm that amivantamab combined with chemotherapy ± lazertinib or immunotherapy regimens (ivucitinib\u002Fsintilimab + bevacizumab + chemotherapy) can extend median PFS post-resistance from approximately 4 months to 6-8 months. As a third-generation TKI, befitinib has demonstrated PFS of 16-22 months in both first-line and post-T790M mutation settings. This study aims to further evaluate the feasibility and safety of \"pemetrexed + carboplatin followed by befotertinib\" for patients resistant to third-generation TKIs.",[42,221,40],"Adjuvant Drug Therapy","2025-09-28",{"date":224,"type":47},"2025-09-30",{"date":226,"type":20},"2025-09",{"date":228,"type":20},"2028-12",{"name":230,"class":54},"Betta Pharmaceuticals Co., Ltd.",{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":237,"eligibilityCriteria":238,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":128,"enrollmentInfo":239,"targetDuration":4,"studyType":21,"phases":241,"briefSummary":242,"conditions":243,"keywords":244,"overallStatus":247,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":4},"100606556","phase-2-primary-tumor-resection-plus-osimertinib-in-advanced-egfr-mutant-non-small-cell-lung-cancer-100606556","NCT07177092","Primary Tumor Resection Plus Osimertinib in Advanced EGFR-mutant Non-small Cell Lung Cancer","Efficacy and Safety of Primary Tumor Resection Combined With Osimertinib in Patients With Advanced EGFR-mutant Non-small Cell Lung Cancer: A Randomized Controlled Study","SURGAN-TKI","Inclusion Criteria:\n\n1. Age 18-75 years, no restriction on sex.\n2. Histologically or cytologically confirmed stage III-IV non-squamous NSCLC, unresectable as assessed by multidisciplinary team (MDT).\n3. Presence of EGFR exon 19 deletion (19Del) or L858R mutation, confirmed by ARMS-PCR, NGS, or other validated methods.\n4. No prior systemic therapy for lung cancer.\n5. ECOG performance status of 0-1.\n6. Estimated life expectancy of at least 6 months.\n7. Primary lung tumor size ≥1 cm, with at least one measurable lesion remaining after resection according to RECIST v1.1 criteria.\n8. Adequate organ function, including:\n\n   ① Hematologic function: absolute neutrophil count ≥1.5 × 10⁹\u002FL; platelet count ≥100 × 10⁹\u002FL; hemoglobin ≥9.0 g\u002FdL.\n\n   ② Hepatic function: ALT and AST ≤2.5 × ULN (≤5 × ULN if liver metastases are present); total bilirubin ≤1.5 × ULN.\n\n   ③ Renal function: serum creatinine ≤1.5 × ULN, or creatinine clearance ≥50 mL\u002Fmin (Cockcroft-Gault formula).\n9. Adequate pulmonary function (must meet at least one of the following to ensure postoperative reserve):\n\n   ① FEV1 ≥1.2 L (or ≥40% of predicted value);\n\n   ② FEV1\u002FFVC ≥0.7, to exclude severe obstructive ventilatory dysfunction;\n\n   ③ DLCO (diffusing capacity for carbon monoxide) ≥40% of predicted value, to assess diffusion capacity.\n\n   ④ If preoperative FEV1 \\\u003C1.2 L or DLCO \\\u003C40%, additional cardiopulmonary exercise testing (e.g., 6-minute walk test, stair climbing test) is recommended to evaluate postoperative pulmonary reserve.\n10. Evaluated by the study team and deemed suitable for primary tumor resection.\n11. Signed written informed consent and willingness to comply with study protocol.\n\nExclusion Criteria:\n\n1. Presence of any other known EGFR mutations.\n2. Histological evidence of mixed small-cell lung cancer (SCLC) or history of transformation to SCLC.\n3. Immunodeficiency: history of primary immunodeficiency disorders, or prior allogeneic organ or bone marrow transplantation.\n4. Active brain metastases. Patients with adequately treated brain metastases may be eligible if they are neurologically stable for at least 2 weeks before enrollment, and are either not requiring corticosteroids or receiving a stable or decreasing dose of ≤10 mg prednisone (or equivalent) once daily.\n5. Pregnancy.\n6. Any serious comorbid condition that, in the opinion of the investigator, may interfere with participation in the study or interpretation of study results, including but not limited to: uncontrolled systemic diseases, psychiatric illness, active or uncontrolled infections, or other abnormal findings from laboratory or clinical examinations.",{"count":240,"type":20},118,[132],"This study is designed to explore whether resecting the primary lung cancer, followed by osimertinib, can improve outcomes for patients with advanced non-small cell lung cancer (NSCLC) harboring sensitizing EGFR mutations (exon 19 deletion or L858R). Patients with stage III-IV NSCLC will be included and randomly assigned to receive either surgery to remove the primary lung cancer followed by osimertinib, or osimertinib alone. All patients will continue treatment until disease progression or they need to stop for another reason. The primary outcome being studied is progression-free survival (PFS). Secondary outcomes include overall survival (OS), objective response rate (ORR), disease control rate (DCR), adverse effects (AEs), serious adverse effects (SAEs) and quality of life (QoL). The findings from this study may help determine whether surgery combined with EGFR tyrosine kinase inhibitor (TKI) provides more benefit than EGFR-TKI alone for patients with EGFR-mutant advanced NSCLC.",[69,40],[69,40,245,246],"Randomized controlled trial","Surgery","NOT_YET_RECRUITING","2025-09-12",{"date":250,"type":47},"2025-09-16",{"date":252,"type":20},"2025-09-08",{"date":254,"type":20},"2030-12-01",{"name":256,"class":92},"Jianxing He",{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":21,"phases":266,"briefSummary":267,"conditions":268,"keywords":275,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":146},"100574161","phase-2-neoadjuvant-befotertinib-combined-bevacizumab-or-platinum-based-double-chemotherapy-for-resectable-locally-advanced-egfr-mutation-positive-non-small-cell-lung-cancer-100574161","NCT06755684","Neoadjuvant Befotertinib Combined Bevacizumab or Platinum-based Double Chemotherapy for Resectable Locally-advanced EGFR Mutation-positive Non-Small Cell Lung Cancer","Neoadjuvant Befotertinib Combined Bevacizumab or Platinum-based Double Chemotherapy for Resectable Locally-advanced EGFR Mutation-positive Non-Small Cell Lung Cancer: a Single-center, Randomized Controlled Trial","Inclusion Criteria:\n\n* NSCLC patient with EGFR sensitive mutation as confirmed by needle biopsy;\n* At stage II-IIIA (TNM Staging, Version 8) as identified by chest CT, PET-CT or\u002Fand EBUS;\n* No systemic metastasis (confirmed by head MRI, whole body bone scan, PET-CT, liver and adrenal CT, etc.);\n* With the feasibility to receive radical surgery ;\n* Good lung function that could tolerate surgical treatment;\n* Aged 18-75 years;\n* At least one measurable tumor foci (the longest diameter measured by CT shall be \\> 10 mm);\n* Other major organs shall function well (liver, kidney, blood system, etc.):\n* ECOG PS score shall be 0-1;\n* The child-bearing female must undergo pregnancy test within 7 days before starting the treatment and the result shall be negative. Reliable contraceptive measures, such as intrauterine device, contraceptive pill and condom, shall be adopted during the trial and within 30 days after completion of the trial. The child-bearing male shall use condom for contraception during the trial and within 30 days after completion of the trial;\n* The patient shall sign the Informed Consent Form.\n\nExclusion Criteria:\n\n* The patient has undergone any systemic anti-cancer treatment for NSCLC, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment, etc.;\n* The patient suffers from any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina pectoris, angina pectoris that starts to attack within the last 3 months, congestive heart failure \\[≥ Grade II specified by New York Heart Association (NYHA)\\], cardiac infarction (6 months before enrollment), severe arrhythmia and liver, kidney or metabolic diseases that requires drug treatment;\n* The patient is a carrier of HIV;\n* The patient has had or is currently suffering from interstitial lung disease;\n* The patient had undergone other major systemic operations or suffered from severe trauma within 3 months before the trial;\n* The patient is allergic to befotertinib or its any excipients;\n* The patient is allergic to bevacizumab or its any excipients;\n* The patient is allergic to platinum-based double chemotherapy or its any excipients;\n* The female patient is in pregnancy or lactation period;\n* There are any conditions under which the investigator considers the patient is not suitable to be enrolled.",{"count":265,"type":20},60,[132],"This study targeted patients with resectable stage II-IIIA non-small cell lung cancer with EGFR mutation",[40,69,269,270,271,272,273,274],"Locally Advanced Non-Small Cell Lung Cancer","Pemetrexed","Carboplatin","Bevacizumab","Antineoplastic Agents","Tyrosine Kinase Inhibitor",[276,42,277,272,278],"EGFR-TKI","Chemotherapy","Locally advanced non-small cell lung cancer","2025-01-03",{"date":281,"type":47},"2025-01-06",{"date":283,"type":47},"2024-11-07",{"date":285,"type":20},"2028-12-31",{"name":287,"class":92},"Peng Zhang"]