[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neoadjuvant-non-small-cell-lung-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neoadjuvant-non-small-cell-lung-cancer":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"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":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100582061","phase-3-lorlatinib-compared-with-concurrent-sequential-chemoradiotherapy-in-stage-iii-alk-positive-lung-adenocarcinoma-100582061",false,"NCT06858410","Lorlatinib Compared with Concurrent\u002F Sequential Chemoradiotherapy in Stage III ALK Positive Lung Adenocarcinoma","A Randomized, Open-label, Multicenter, Phase III Study of Lorlatinib Compared with Concurrent\u002F Sequential Chemoradiotherapy As Definitive Treatment in Patients with Locally Advanced, Unresectable Stage III ALK Positive Lung Adenocarcinoma","Inclusion Criteria:\n\n* Study Population: Patients with histologically or cytologically confirmed diagnosis of ALK-positive, lung adenocarcinoma who present with locally advanced, unresectable (Stage III) disease (according to Version 8 of the International Association for the Study of Lung Cancer \\[IASLC\\]).\n* Tumor Requirements: At least 1 measurable target lesion per RECIST v. 1.1\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1. Life expectancy at least 12weeks at Day1.\n* Age ≥18 years.\n* Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.\n\nExclusion Criteria:\n\n* Previously received any ALK-TKIs or any thoracic radiotherapy\n* Active infection, including Bacteria, fungi or viruses\n* Any evidence of severe or uncontrolled systemic diseases, which in the Investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the protocol\n* Inadequate bone marrow reserve or organ function.\n\n  1. Absolute neutrophil count \\\u003C1.5\\*109\u002FL\n  2. Platelet count \\\u003C90\\*109\u002FL\n  3. Hemoglobin \\\u003C90 g\u002FL (\\\u003C9 g\u002FdL) d Alanine aminotransferase \\> 3 times the upper limit of normal (ULN)\n\n  e. Aspartate aminotransferase \\> 3 times the upper limit of normal (ULN) f. Total bilirubin \\> 1.5\\*ULN g. Creatinine \\>1.5\\*ULN or creatinine clearance \\\u003C45 mL\u002Fmin (calculated by Cockcroft-Gault formula)\n* History of interstitial lung disease (ILD) or active ILD or pneumonia\n* Pregnant female patients; breastfeeding female patients; fertile male patients and female patients of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 97 days, if male or 35 days if female, after the last dose of investigational product under lorlatinib.\n* Participation in other studies involving investigational drug(s) within 2 weeks prior to study entry and\u002For during study participation.\n* Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements","ALL","18 Years",{"count":19,"type":20},36,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","The project is a Phase III, randomized, open-label, multicenter study in which approximately 36 patients with unresectable Stage III ALK positive Lung Adenocarcinoma will be randomized 1:1 to receive lorlatinib or concurrent\u002Fsequential platinum-based chemoradiotherapy",[26],"Neoadjuvant Non-Small Cell Lung Cancer",[28,29,30,31],"ALK-positive","Stage III unresectable","Lung Adenocarcinoma","NSCLC","NOT_YET_RECRUITING","2025-02-27",{"date":35,"type":36},"2025-03-05","ACTUAL",{"date":38,"type":20},"2025-03",{"date":40,"type":20},"2030-08",{"name":42,"class":43},"Guangdong Association of Clinical Trials","OTHER",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":4},"100568565","phase-2-lorlatinib-as-neoadjuvant-treatment-in-stage-ib-iiib-alk-rearranged-non-small-cell-lung-cancer-100568565","NCT06682884","Lorlatinib as Neoadjuvant Treatment in Stage IB-IIIB ALK-rearranged Non-Small Cell Lung Cancer","Phase II, Open-label, Single-arm, Prospective, Multi-center Study to Evaluate the Efficacy and Safety of Lorlatinib as Neoadjuvant Treatment in Surgically Resectable Stage IB-IIIB ALK-rearranged Non-Small Cell Lung Cancer (NEOLORA)","NEOLORA","Inclusion Criteria:\n\n* Aged ≥18 years\n* Imaging confirmed, resectable stage IB, II, IIIA or selected IIIB (including T4N2，per AJCC 8th edition)\n* Histologically\u002Fcytologically confirmed lung adenocarcinoma\n* Documented ALK-rearrangement mutation positive (assessed by a local laboratory)\n* ECOG PS 0-1\n* Patients must be treatment-naive for NSCLC and eligible to receive treatment with Lorlatinb.\n* Measurable disease, as defined by RECIST v1.1\n* Hematology, liver and kidney function are adequate for neoadjuvant therapy.\n* Cardiopulmonary function suitable for surgical treatment (ECG, echocardiography, pulmonary function or blood gas analysis).\n* Male participants must be willing to use acceptable methods of contraception.\n* Female participants of childbearing potential must agree to use acceptable methods of contraception.\n* Ability to provide written informed consent.\n\nExclusion Criteria:\n\n* Mixed squamous cell carcinoma, large cell carcinoma, small cell lung cancer.\n* Prior treatment with any systemic anti-cancer therapy for locally advanced NSCLC\n* Non-resectable stage IB, II, IIIA or selected IIIB NSCLC evaluated by thoracic surgeons.\n* Unable to tolerate curative surgery per anaesthesiologist evaluation.History of organ transplant.\n* Pregnant or lactating, or intending to become pregnant during the study\n* Evidence of any severe or uncontrolled systemic disease, including uncontrolled hypertension and active bleeding, that the investigator considers to be detrimental to patient participation in the study or to adherence to the protocol.\n* Past medical history of Interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.\n* A clear past history of neurological or psychiatric disorders, including epilepsy or dementia;\n* Judgement by investigator that the subject should not participate in the study if the subject is unlikely to comply with the study procedures, restrictions and requirements.",{"count":53,"type":20},25,[55],"PHASE2","This project was designed To explore the pathological complete response (pCR) of lorlatinib as neoadjuvant treatment. Twenty-five patients will be involved in this study.\n\nThese patients will receive lorlatinib neoadjuvant therapy for 6-8 weeks (determined by clinicians' decision based on clinical practice) and then underwent surgery.\n\nPrevious small-sample clinical studies on ALK inhibitors as neoadjuvant therapy in resectable NSCLC have shown promising outcomes including MPR and pCR, supporting the potential of ALK TKIs in this setting.",[26],[31,59,60,61],"Neoadjuvant","ALK-rearranged","Lorlatinib","2024-11-08",{"date":64,"type":36},"2024-11-12",{"date":66,"type":20},"2024-11-15",{"date":68,"type":20},"2027-05-31",{"name":70,"class":43},"Peking University People's Hospital"]