[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-small-cell-lung-cancer-with-egfr-mutation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-small-cell-lung-cancer-with-egfr-mutation":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,71,96],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100504796","phase-3-glutamine-plus-l-reuteri-prevents-tki-therapy-diarrhea-in-patients-with-nsclc-100504796",false,"NCT05852990","Glutamine Plus L. Reuteri Prevents TKI Therapy-diarrhea in Patients With NSCLC","Effect of Glutamine Plus Lactobacillus Reuteri Added to an Astringent Diet in Preventing Diarrhea Caused by Tyrosine Kinase Inhibitors (TKIs) in Patients With Advanced Non-small Cell Lung Cancer","Inclusion Criteria:\n\n* Both sexes\n* ≥ 18 years old\n* Pathologically confirmed diagnosis of NSCLC\n* Stage IIIB - IV by the American Joint Committee of Cancer Version 8.\n* Candidates to receive EGFR-TKI treatment (1st \\& 2nd generation TKI)\n* ECOG score ≤ 2\n* Life expectancy \\> eight weeks\n* Signed written informed consent\n\nExclusion Criteria:\n\n* Patients who cannot attend the first protocol appointment.\n* Treatment with other anti-cancer therapy\n* Participating in other clinical trials in the former four weeks\n* Any other serious condition or uncontrolled active infection, altered mental status or psychiatric disorder that, in the investigator´s opinion, would limit the ability of an individual to meet the requirements of the study or which affects the interpretability of the results.\n* Active hepatitis virus infection (any serotype) or chronic infection with a potential risk of reactivation evaluated through a serological panel.\n* Active HIV infection.\n* Breastfeeding.","ALL","18 Years","80 Years",{"count":20,"type":21},28,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This open-label randomized clinical trial aims to evaluate the glutamine plus Lactobacillus reuteri supplementation effect in a standard-of-care diet in EGFR mutant patients with advanced non-small cell lung cancer (NSCLC) under tyrosine kinase inhibitors (TKIs) therapy.\n\nThe main question it aims to answer is ¿What is the effect of glutamine plus L. reuteri added to an astringent diet in preventing diarrhea generated by TKI therapy?\n\nPatients will receive an astringent diet supplemented with 10 grams of glutamine and L. reuteri (100 million CFU). Researchers will compare the Glutamine plus L. reuteri diet with a standard astringent diet to see if TKI therapy diarrhea is prevented.",[27],"Non-Small Cell Lung Cancer With EGFR Mutation",[29,30,31,32,33],"Non-Small Cell Lung Cancer","EGFR mutation","Glutamine","Lactobacillus reuteri","standard-care diet","RECRUITING","2026-04-06",{"date":37,"type":38},"2026-04-09","ACTUAL",{"date":40,"type":38},"2022-03-01",{"date":42,"type":21},"2027-12-12",{"name":44,"class":45},"Instituto Nacional de Cancerologia de Mexico","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":70},"100567431","phase-2-a-phase-2-clinical-study-of-combination-therapy-with-absk043-and-firmonertinib-100567431","NCT06668103","A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Firmonertinib","A Phase 2, Open-Label Study to Evaluate the Efficacy and Safety of ABSK043 Combined With Firmonertinib in Patients With EGFR Mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer(NSCLC)","Inclusion Criteria:\n\n1. Histologically or cytologically documented locally advanced or metastatic NSCLC\n2. At least 1 measurable lesion as assessed by Investigator as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)\n3. Inclusion Criteria Specific to Dose Escalation cohort and Dose Confirmation Cohort：Must has disease progression following treatment with EGFR-TKI in the locally advanced or metastatic setting for locally advanced or metastatic disease Documentation of PDL1 expression positive (TPS\u002FTC≥1%)detected from tumor tissue Inclusion Criteria Specific to Dose expansion Cohort： Must not have received any other prior systemic cancer therapies in the locally advanced\u002Fmetastatic setting PDL1 expression positive (TPS\u002FTC≥1%) as assessed by central laboratory from tumor tissue\n4. Adequate bone marrow reserve and organ function based on local laboratory data .\n5. Documented genetic testing reports confirmed the presence of EGFR L858R or EGFR exon 19 del mutations in tumor or plasma ctDNA.\n\nExclusion Criteria:\n\n1. 1\\. Histological or cytological examinations suggest that NSCLC squamous cells is the predominant histology, or contains small cell lung cancer, neuroendocrine carcinoma, etc.\n2. Has a history of interstitial lung disease (ILD)\u002Fpneumonitis or active ILD\n3. Has spinal cord compression or clinically active central nervous system metastases, defined as symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Participants with clinically inactive brain metastases may be included in the study\n4. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, Grade ≤1 or baseline.\n5. Is receiving chronic systemic corticosteroids dosed at \\>10 mg prednisone or equivalent anti-inflammatory activity or any form of immunosuppressive therapy.\n6. Uncontrolled or significant cardiovascular disease\n7. Has a known human immunodeficiency virus (HIV) infection that is not well controlled.\n8. Any evidence of severe or uncontrolled diseases or other factors which in the Investigator's opinion makes it undesirable for the patients to participate in the study.",{"count":55,"type":21},54,[57],"PHASE2","This is an open-label phase 2 study to evaluate the safety, tolerability and preliminary anti-tumour activity of ABSK043 in combination with Firmonertinib in patients with Epidermal Growth Factor Receptor-mutated (EGFRm+) locally advanced or metastatic NSCLC.",[27],"2024-12-09",{"date":62,"type":38},"2024-12-12",{"date":64,"type":38},"2024-11-25",{"date":66,"type":21},"2028-06-30",{"name":68,"class":69},"Abbisko Therapeutics Co, Ltd","INDUSTRY",5,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":82,"conditions":83,"keywords":84,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":46},"100565394","phase-1-a-phase-i-study-of-cft8919-in-patients-with-advanced-nsclc-100565394","NCT06641609","A Phase I Study of CFT8919 in Patients With Advanced NSCLC","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of CFT8919 Capsules in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC).","Inclusion Criteria:\n\n1. Dose-Escalation and Dose-Expansion Phases: Patients with histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring the EGFR-L858R mutation, who have failed standard treatment (disease progression or intolerance), lack standard treatment options, or are deemed unsuitable for standard treatment by the investigator, or have refused standard treatment.\n2. Cohort-Expansion Phase: In addition to the above criteria, the following must also be met:\n\n   * Cohort A: Patients with locally advanced or metastatic NSCLC harboring the EGFR-L858R mutation who have experienced disease progression after third-generation EGFR-TKI treatment and carry secondary EGFR mutations (such as C797S, L718Q, G724S, S768I, etc.).\n   * Cohort B: Patients with locally advanced or metastatic NSCLC harboring the EGFR-L858R mutation who have failed standard treatment or are unsuitable for or have refused standard treatment (patients with secondary EGFR mutations are prioritized for Cohort A).\n3. • Dose-Escalation Phase requires evaluable lesions, while Dose-Expansion and Cohort-Expansion Phases require measurable lesions as defined by RECIST V1.1.\n4. • Age ≥18 years, no gender restrictions.\n5. • Expected survival ≥12 weeks.\n6. • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n7. • Adequate organ function, meeting the following criteria:\n\n   * Hematologic: Absolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL (1500\u002Fmm³), platelets ≥100 × 10⁹\u002FL, hemoglobin ≥9 g\u002FdL (90 g\u002FL) without transfusion or hematopoietic growth factors within 14 days prior to screening.\n   * Coagulation: International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤1.5 × the upper limit of normal (ULN).\n   * Liver: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN, or ≤5.0 × ULN in the presence of liver metastases; total bilirubin (TBIL) ≤1.5 × ULN, or ≤3.0 × ULN in the presence of liver metastases or known Gilbert\\'s syndrome (unconjugated hyperbilirubinemia).\n   * Kidney: Serum creatinine (Scr) ≤1.5 × ULN, or for patients with Scr \\>1.5 × ULN, creatinine clearance (Ccr) ≥50 mL\u002Fmin (calculated using the Cockcroft-Gault formula); urine protein ≤1+, or if ≥2+, 24-hour urine protein quantification showing \\<1 g.\n8. • Toxicity from prior anti-tumor treatments must have resolved to CTCAE grade ≤1 (except for toxicities that, in the investigator\\'s judgment, are long-lasting and non-recoverable but pose no safety risk and are ≤2 in grade).\n9. • Patients must have been previously diagnosed with the EGFR-L858R mutation via local testing. In the Dose-Escalation and Dose-Expansion Phases, patients who progressed on prior EGFR-TKI treatment must provide the genetic mutation results from their most recent EGFR-TKI treatment. For Cohort A patients, progression on third-generation EGFR-TKI treatment must have confirmed the presence of secondary EGFR mutations (e.g., C797S, L718Q, G724S, S768I) via tissue or blood tests.\n10. • Patients must be willing to provide blood samples and optionally provide tissue samples for exploratory biomarker research.\n11. • Non-breastfeeding women of childbearing potential must have a negative serum or urine pregnancy test within 7 days before starting study treatment, and all enrolled patients must agree to use medically accepted contraception for 1 month prior to treatment, during the entire treatment period, and for 3 months after completing treatment.\n12. • Signed informed consent form.\n\nExclusion Criteria:\n\n1. Prior or ongoing treatment with EGFR-L858R-targeted PROTAC therapies.\n2. Less than 5 half-lives or 4 weeks (whichever is shorter) since the last anti-tumor treatment before the first dose of study drug; less than 6 weeks since the last treatment with nitrosoureas or mitomycin C; less than 1 week since the last anti-tumor herbal treatment.\n3. Patients who underwent major surgery (as defined by the investigator) or experienced significant trauma within 4 weeks before the first dose of study drug; patients who received radiation therapy within 4 weeks prior to the first dose, except for palliative radiation (e.g., for bone metastases to control pain) that is unlikely to affect bone marrow function, which may allow inclusion 2 weeks post-radiation.\n4. Patients with unstable central nervous system (CNS) metastases (those who have received treatment for brain metastases, have stable brain lesions, and have discontinued corticosteroids, anticonvulsants, or mannitol treatment for ≥2 weeks before the first dose may be considered for inclusion); patients with leptomeningeal metastases or spinal cord compression.\n5. History of other primary malignancies within the past 3 years, except for malignancies that have been treated curatively with no known active disease and a low risk of recurrence, or adequately treated non-melanoma skin cancers, cervical carcinoma in situ, or papillary thyroid carcinoma.\n6. Clinically significant cardiovascular diseases, including but not limited to:\n\n   * a) Unstable angina, acute myocardial infarction, or New York Heart Association (NYHA) class II-IV heart failure;\n   * b) Ventricular arrhythmias or conduction disorders requiring clinical intervention (e.g., complete left bundle branch block, third-degree atrioventricular \\[AV\\] block, or second-degree AV block);\n   * c) Uncontrolled atrial fibrillation or atrial flutter;\n   * d) Prolonged QTcF interval (resting mean QTcF \\>450 msec for men or \\>470 msec for women);\n   * e) Left ventricular ejection fraction (LVEF) \\<50% on echocardiography;\n   * f) Hypertension not controlled with medication.\n7. • History of interstitial lung disease (ILD) or non-infectious pneumonitis.\n8. • Adrenal insufficiency.\n9. • Use of proton pump inhibitors, strong CYP3A4 inhibitors or inducers, or P-glycoprotein inhibitors or inducers within 7 days before the first dose.\n10. • History of chronic diarrhea or diseases causing chronic diarrhea, such as Crohn\\'s disease or irritable bowel syndrome, or any condition that might affect drug absorption (e.g., continuous diarrhea \\>CTCAE grade 1 within 1 week prior to the first dose).\n11. • Known severe hypersensitivity to the study drug or any of its excipients.\n12. • History of deep vein thrombosis, pulmonary embolism, or any other serious thromboembolic events within 6 months before the first dose, except for catheter-related or superficial venous thrombosis, or lacunar infarcts.\n13. • Clinically significant gastrointestinal bleeding or hemoptysis within 3 months before the first dose, or any other significant bleeding history (e.g., pulmonary hemorrhage).\n14. • Clinically significant third-space fluid accumulation (e.g., uncontrolled ascites, pleural effusion, or pericardial effusion requiring repeated drainage).\n15. • Receipt of autologous transplantation within 3 months or allogeneic organ or stem cell transplantation within 6 months prior to the first dose.\n16. • Active hepatitis B virus (HBV) infection (screening positive for HBsAg or anti-HBc, and HBV DNA levels above the detection limit; patients with stable disease for at least 4 weeks after antiviral therapy may be included), active hepatitis C virus (HCV) infection (positive HCV antibodies and detectable HCV RNA), human immunodeficiency virus (HIV) infection, or active syphilis infection.\n17. • Active infection requiring systemic treatment within 1 week before the first dose.\n18. • History of substance abuse or any condition that, in the investigator\\'s judgment, may interfere with study participation or assessment of study results, or any unstable condition that may compromise patient safety or compliance.",{"count":79,"type":21},166,[81],"PHASE1","The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of CFT8919 capsules in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying EGFR mutations. The main questions it aims to answer are:\n\n* What is the maximum tolerated dose (MTD) of CFT8919?\n* Does CFT8919 demonstrate antitumor activity in these patients?\n\nParticipants will:\n\n* Take CFT8919 capsules at different doses.\n* Undergo regular assessments for safety, pharmacokinetics, and tumor response. Researchers will compare different dose levels to determine the best balance between safety and efficacy.",[27],[85,30],"Non-small cell lung cancer","NOT_YET_RECRUITING","2024-10-12",{"date":89,"type":38},"2024-10-15",{"date":91,"type":21},"2024-12-13",{"date":93,"type":21},"2026-04-03",{"name":95,"class":69},"Betta Pharmaceuticals Co., Ltd.",{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":22,"phases":105,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":117},"100539639","phase-1-a-phase-ibii-clinical-study-of-gh21-capsules-combined-with-osimertinib-mesylate-tablets-in-patients-with-nsclc-100539639","NCT06306456","A Phase Ib\u002FII Clinical Study of GH21 Capsules Combined With Osimertinib Mesylate Tablets in Patients With NSCLC","A Phase Ib\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Oral Administration of GH21 Capsules Combined With Osimertinib Mesylate Tablets in Patients With Advanced NSCLC With EGFR Mutations","Inclusion Criteria:\n\n1. Subjects or their legal representatives can understand and voluntarily sign the written ICF (before the start of screening and any study procedures);\n2. Male or female subjects aged ≥18 years;\n3. Advanced NSCLC patients with EGFR mutations confirmed by cytological or histological assessments, and meet the following requirement:\n\n   * Phase Ib： patients with disease progression previously at least treated with third-generation EGFR-TKIs and platinum-containing chemotherapy;\n   * Phase IIa and IIb：patients with disease progression previously at least treated with a third-generation EGFR-TKIs (Osimertinib, Furmonertinib Almonertinib etc.).\n4. Patients have at least one measurable lesion as defined by RECIST v1.1 (a tumor lesion in the area that has undergone radiotherapy or other loco-regional therapies, is generally not considered as measurable unless there is a disease progression in the lesion);\n5. Consent to provide samples for genetic testing;\n6. Life expectancy of ≥ 3 months;\n7. ECOG PS score of 0-1;\n8. The subjects must have adequate organ functions;\n9. Male and female of reproductive potential must agree to take reliable contraceptive measures (hormone or barrier methods or abstinence) from signing the ICF until 30 days after the last dose. Pregnancy test results must be negative for female of reproductive potential within 7 days prior to the first dose of the investigational product.\n\nExclusion Criteria:\n\n1. Subjects who receive any chemotherapy or antitumor biologics within 3 weeks, or antitumor therapies such as radiotherapy and endocrine therapy within 4 weeks prior to the first dose of the investigational product, except for the following:\n\n   * Use of nitrosoureas or mitomycin C within 6 weeks prior to the first dose of the investigational product;\n   * Oral administration of fluorouracils, small molecule targeted drugs, and Chinese herbal medicines or Chinese patent medicines with antitumor indications within 5 half-lives or 2 weeks before the first dose of the investigational product (whichever is shorter);\n   * Small molecule TKI inhibitors within 5 half-lives or 2 weeks prior to the first dose of the investigational product (whichever is shorter);\n   * Local palliative radiotherapy within 2 weeks prior to the first dose of the investigational product;\n2. Subjects who have had another investigational new drug or therapy within 4 weeks prior to the first dose of the investigational product;\n3. Subjects who have had a major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the first dose of the investigational product, or require an elective surgery during the study;\n4. Subjects who have received strong CYP3A4 inhibitors or inducers and strong P-gp inhibitors or inducers within 2 weeks or within 5 half-lives (whichever is longer) prior to the first dose of the investigational product;\n5. Subjects with evidence of the following heart conditions:\n\n   * Acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting, cerebrovascular accident, or transient ischemic attack within 6 months prior to the first dose of the investigational product;\n   * Grade III-IV heart failure diagnosed according to the cardiac function classification of the New York Heart Association at screening;\n   * Echocardiography (ECHO) shows the left ventricular ejection fraction (LVEF) ≤ 50% at screening;\n   * QT interval corrected by Fridericia method (QTcF) is ≥ 450 ms (male) or ≥ 470 ms (female) at screening;\n   * Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg) despite of medication treatment at screening;\n6. Subjects with dysphagia, gastrointestinal disorders that affect drug absorption, or other malabsorption conditions, such as intestinal obstruction, Crohn's disease, ulcerative colitis, short bowel syndrome, delayed gastric emptying, or severe gastrointestinal toxicities that have not resolved to Grade 2 or lower prior to the first dose of the investigational product; or subjects are diagnosed with a clinically significant or acute gastrointestinal disease;\n7. Subjects with poorly controlled clinical pleural ascites assessed by the investigator;\n8. Subjects with active central nervous system metastasis and\u002For carcinomatous meningitis (e.g., brain metastases accompanied by central nervous system symptoms, including headache, vomiting and dizziness, etc.);\n9. Subjects with interstitial pneumonia, or any evidence of clinically active interstitial lung disease within 6 months before the first dose of the investigational product;\n10. Subjects with a history of other malignancies (excluding those deemed eligible by the investigator, such as skin squamous cell carcinoma in situ, basal cell carcinoma, and cervical cancer in situ that have been cured and have not relapsed for 5 years; or subjects deemed eligible by the investigator in Phase Ib);\n11. Subjects with a history of severe allergies, a history of allergies to Osimertinib, or to multiple drugs;\n12. Subjects with hepatitis B virus infection (HBsAg positivity and DNA copies \\\u003C 100 IU\u002FmL); or hepatitis C virus infection (HCV antibody positivity, and HCV RNA \\> ULN); or human immunodeficiency virus infection (HIV antibody positivity);\n13. Subjects with active infections requiring anti-infective treatment (Grade ≥ 2) or fever \\> 38°C of unknown etiology within 28 days prior to the first dose of the investigational product;\n14. Subjects with any toxicity caused by a previous antitumor therapy that has not resolved to Grade ≤ 1 according to CTCAE 5.0 (except for alopecia, Grade 2 peripheral neuropathy, and\u002For other Grade ≤ 2 AEs of insignificant safety risks) before the first dose of the investigational product;\n15. Female subjects who are pregnant or breastfeeding;\n16. Subjects who are not suitable for this study due to any clinical or laboratory abnormalities or other reasons as assessed by the investigator.",{"count":104,"type":21},94,[81,57],"This study, including phase Ib , phase IIa and phase IIb, aims to evaluate the safety, tolerability, PK profile, efficacy and to determine the RP2D of GH21 capsules combined with Osimertinib mesylate tablets in NSCLC patients with EGFR mutations.",[27],"2024-07-04",{"date":110,"type":38},"2024-07-08",{"date":112,"type":38},"2024-03-05",{"date":114,"type":21},"2026-12-31",{"name":116,"class":45},"Suzhou Genhouse Bio Co., Ltd.",6]