[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"alk-gene-mutation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:alk-gene-mutation":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,56,86,112,137,163,186,209],{"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":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100644656","management-strategy-of-1l-lorlatinib-with-hyperlipidemia-in-stage-iiib-iv-alk-positive-nsclc-100644656",false,"NCT07674524","Management Strategy of 1L Lorlatinib With Hyperlipidemia in Stage IIIB-IV ALK Positive NSCLC","Management Strategy of 1L Lorlatinib With Hyperlipidemia in Stage IIIB-IV ALK Positive NSCLC: A Multi-center Prospective Study in China","Inclusion Criteria:• Inclusion Criteria (Part A and Part B)\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment (Part A and Part B):\n\n1. Diagnosis:\n\n   1. Histologically or cytologically confirmed locally advanced \\[defined as Stage IIIB\u002FC per AJCC v7.0 and not amenable to multimodality treatment\\] or metastatic (Stage IV) ALK-positive NSCLC; ALK status must be confirmed by Ventana ALK (D5F3) Companion Diagnostic (CDx) IHC (Ventana ULTRA or XT platform), FISH, PCR, next-generation sequencing (NGS), or circulating tumor DNA (ctDNA) testing;\n   2. At least one measurable target lesion per RECIST v1.1, not previously irradiated; brain metastases are allowed;\n2. No prior systemic therapy for advanced (Stage IIIB\u002FC not amenable to multimodality treatment) or metastatic (Stage IV) disease;\n3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0, 1, or 2;\n4. Age ≥ 18 years;\n5. Hyperlipidemia during first-line lorlatinib treatment, with ULN ≤ TC \\\u003C 12.93 mmol\u002FL (Grade 1-3);\n6. Life expectancy ≥ 6 months;\n7. Negative serum pregnancy test at screening for women of childbearing potential. Non-childbearing potential must meet at least one of the following:\n\n   1. Postmenopausal status: regular menstrual cessation ≥ 12 months with no other pathological or physiological cause (serum FSH level may be used to confirm postmenopausal status, if applicable);\n   2. Hysterectomy and\u002For bilateral oophorectomy;\n   3. Medically confirmed ovarian failure; All other women (including those with tubal ligation) are considered of childbearing potential;\n8. Provide signed and dated informed consent from the patient (or legal representative), indicating full understanding of the study-related information.\n\nPart B Additional Inclusion Criteria\n\nPatients with at least one prior major ASCVD event, or baseline LDL-C ≥ 4.9 mmol\u002FL ± high-risk factors.\n\nMajor ASCVD events:\n\n1. Acute coronary syndrome (ACS) within the past 1 year;\n2. History of myocardial infarction (excluding recent ACS);\n3. History of ischemic stroke;\n4. Symptomatic peripheral artery disease (PAD), including prior revascularization or amputation.\n\nHigh-risk factors (prioritized):\n\n1. Premature coronary artery disease (male \\\u003C 55 years; female \\\u003C 65 years);\n2. Familial hypercholesterolemia;\n3. History of coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI);\n4. Diabetes mellitus;\n5. Hypertension;\n6. Chronic kidney disease (CKD) stage 3-4;\n7. Current smoker. -\n\nExclusion Criteria:\n\nExclusion Criteria (Part A and Part B)\n\n1. Mixed squamous cell carcinoma, large cell carcinoma, or small cell lung cancer\n2. Prior systemic anticancer therapy for NSCLC, including chemotherapy, biologic therapy, immunotherapy, or any investigational drug\n3. Diagnosed genetic hypercholesterolemia (e.g., familial hypercholesterolemia, Part A only) or secondary dyslipidemia with a clear etiology (e.g., hypothyroidism, uncontrolled diabetes, nephrotic syndrome)\n4. Known allergy or history of severe adverse reaction to any study drug (including lorlatinib, statins, ezetimibe, or evolocumab)\n5. Presence of other severe diseases that may affect study compliance or outcome assessment, including advanced renal failure (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m²) or severe hepatic impairment (Child-Pugh Class C)\n6. Pregnant or lactating women, or fertile individuals (male or female) unwilling to use effective contraception during the study\n7. Currently participating in another interventional clinical study that may interfere with this study; patients expected to be unable to complete follow-up or the first tumor efficacy assessment; patients with mental or psychological disorders who cannot provide informed consent or comply with study requirements (including treatment and follow-up)\n\nPart B Additional Exclusion Criteria\n\nSubjects meeting any of the following criteria will not be included in this clinical study:\n\n1. Major surgery within 4 weeks prior to randomization; minor surgery (e.g., port placement) is permitted provided the incision is adequately healed\n2. Radiotherapy within 2 weeks prior to enrollment, including stereotactic or partial brain radiotherapy. Patients who complete whole brain radiotherapy within 4 weeks prior to randomization, or palliative radiotherapy outside the CNS within 48 hours prior to randomization, are also excluded\n3. Gastrointestinal abnormalities including: inability to take oral medication; need for parenteral nutrition; prior surgery affecting absorption (e.g., total gastrectomy, gastric banding); active inflammatory bowel disease, chronic diarrhea, symptomatic diverticular disease; treatment for active peptic ulcer within the past 6 months; malabsorption syndrome\n4. Known or suspected severe hypersensitivity to the study drug or any of its excipients\n5. History of extensive, disseminated, or bilateral disease, or current Grade 3-4 interstitial fibrosis\u002Finterstitial lung disease, including but not limited to: pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, bronchiolitis obliterans, and pulmonary fibrosis\n6. Active malignancy within 3 years prior to randomization (excluding NSCLC, non-melanoma skin cancer, localized prostate cancer not requiring immediate treatment, or any carcinoma in situ)\n7. Concurrent use within 12 days prior to first lorlatinib dose of:\n\n   1. Strong CYP3A inhibitors (e.g., grapefruit juice or grapefruit\u002Frelated citrus fruits \\[Seville oranges, pomelos\\]; boceprevir, cobicistat, conivaptan, itraconazole, ketoconazole, posaconazole; ritonavir alone or with danoprevir, elvitegravir, indinavir, lopinavir, paritaprevir, ombitasvir, dasabuvir, saquinavir, tipranavir; telaprevir, troleandomycin, voriconazole. Topical use such as 2% ketoconazole cream is permitted where applicable)\n   2. Known narrow therapeutic index CYP3A substrates (e.g., astemizole, terfenadine, cisapride, pimozide, quinidine, tacrolimus, cyclosporine, sirolimus, alfentanil, fentanyl \\[including transdermal patch\\], or ergot alkaloids \\[ergotamine, dihydroergotamine\\]) (withdrawn from U.S. market)\n   3. Known strong CYP3A inducers (e.g., carbamazepine, enzalutamide, mitotane, phenytoin, rifampin, St. John's Wort)\n   4. Known narrow therapeutic index P-gp substrates (e.g., digoxin)\n8. Other severe acute or chronic medical or psychiatric conditions, including suicidal ideation or behavior within the past 1 year, that may increase the risk of study participation or study drug use, or laboratory abnormalities that may interfere with interpretation of study results, and patients deemed by the investigator to be unsuitable for enrollment\n9. Participation in another investigational drug study within 2 weeks prior to enrollment and\u002For during the study period","ALL","18 Years",{"count":19,"type":20},160,"ESTIMATED","24 Years","OBSERVATIONAL","For Patients and Families\n\nBrief Title: Management of 1L Lorlatinib with Hyperlipidemia in ALK+ Advanced NSCLC\n\nWhat is this study about?\n\nThis study is for people with ALK-positive non-small cell lung cancer (NSCLC) who are taking lorlatinib (Lorbrena®) as their first treatment and have developed high cholesterol (hyperlipidemia) as a side effect.\n\nWhy is this study needed?\n\nLorlatinib is a highly effective targeted therapy, but it frequently causes elevated cholesterol and triglycerides. There is currently no standard guideline on how to best manage this side effect. This study aims to find the best approach to control lipid levels while on lorlatinib treatment.\n\nWhat will happen in this study?\n\nThe study has two parts:\n\n* Part A (Observational) : About 100 participants. Doctors manage hyperlipidemia according to routine clinical practice. Researchers simply observe and record which lipid-lowering treatments are used and how well they work.\n* Part B (Randomized Controlled Trial) : 60 participants with high-risk factors are randomly assigned to either:\n* Intensive treatment: rosuvastatin + ezetimibe + evolocumab\n* Standard treatment: rosuvastatin + ezetimibe\n\nWhat tests are involved?\n\n* Blood tests for lipid levels at baseline, Weeks 4, 8, 20, and 24\n* Routine CT or MRI scans for tumor assessment\n* Some participants in Part B may have a non-invasive vascular ultrasound (FMD) test\n* Total participation per patient: up to 7 months\n\nIs this study safe?\n\n* ✅ Approved by the Ethics Committee of Sun Yat-sen University Cancer Center\n* ✅ All drugs used (lorlatinib, statins, ezetimibe, evolocumab) are already approved and widely used\n* ✅ An independent Data Monitoring Committee (DMC) monitors safety throughout the study\n* ✅ Participants may withdraw at any time without affecting their regular care\n\nFor Healthcare Providers\n\nStudy Title: Management strategy of 1L Lorlatinib with Hyperlipidemia in Stage IIIB-IV ALK positive NSCLC: A multi-center prospective study in China\n\nSponsor \u002F Investigators: Sun Yat-sen University Cancer Center (PI: Prof. Zhang Li)\n\nStudy Type:\n\n* Part A: Observational, prospective, real-world cohort study\n* Part B: Prospective, randomized controlled trial (RCT)\n\nEstimated Enrollment: 160 participants (Part A: \\~100, Part B: 60)\n\nStudy Duration: Approximately 4 years (anticipated completion: December 2029)\n\nKey Inclusion Criteria:\n\n* Stage IIIB-IV ALK+ NSCLC (confirmed by IHC, FISH, PCR, NGS, or ctDNA)\n* No prior systemic therapy for advanced\u002Fmetastatic disease\n* ECOG PS 0-2\n* Age ≥ 18 years\n* Hyperlipidemia (ULN ≤ TC \\\u003C 12.93 mmol\u002FL, Grade 1-3) while on first-line lorlatinib\n* At least one measurable lesion per RECIST v1.1\n* Life expectancy ≥ 6 months\n\nPrimary Endpoints:\n\n* Part A: Describe real-world treatment patterns for hyperlipidemia management\n* Part B: Percentage change in LDL-C from baseline to Week 12\n\nOversight:\n\n* Independent Data Monitoring Committee (DMC)\n* Trial Management Committee\n* Ethics Committee of Sun Yat-sen University Cancer Center (Approval No. B2026-159-01)\n\nParticipating Centers: 8 sites across China",[25,26,27,28],"Non-Small Cell Lung Cancer (NSCLC)","Hyperlipidemia","ALK Gene Mutation","ALK-positive",[30,31,26,32,33,34,35,36,37,38,39,40,41,42],"Lorlatinib","ALK-positive NSCLC","Lipid management","Statin","Ezetimibe","Evolocumab","PCSK9 inhibitor","Real-world study","Randomized controlled trial","Prospective study","Endothelial function","FMD","Multi-center","NOT_YET_RECRUITING","2026-06-24",{"date":46,"type":47},"2026-06-29","ACTUAL",{"date":49,"type":20},"2026-08-01",{"date":51,"type":20},"2029-12-31",{"name":53,"class":54},"Sun Yat-sen University","OTHER",1,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":65,"phases":66,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":55},"100494040","phase-1-alectinib-pharmacokinetic-in-patients-with-nsclc-100494040","NCT05713006","Alectinib Pharmacokinetic in Patients With NSCLC","A Phase I\u002FII Open-label Clinical Trial to Evaluate the Pharmacokinetics of Alectinib With Sequential Dose Escalation in Patients Diagnosed With ALK-rearranged 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* Recurrent disease (at least 180 days from curative intent treatment)\n* ALK rearrangements tested by FDA-approved tests (IHQ or FISH)\n* Karnofsky PS scale ≥ 70%\n* Having received first-line treatment with anti-ALK inhibitors and one previous line of platinum-based chemotherapy.\n* Measurable disease as referred by RECIST version 1.1\n* Symptomatic brain metastases could receive prior treatment with radiotherapy or surgery for at least two weeks before treatment initiation.\n* Asymptomatic brain metastases could not receive local therapy before study inclusion.\n* Negative highly sensitive pregnancy test (serum or urine) within 72 days before first dose intervention.\n* Sexually active patients should use a contraceptive method with a failure rate of less than 1% per year.\n* Signed written informed consent\n* Adequate organ function (hematological, liver, and renal function)\n* Life expectancy of at least 12 weeks\n\nExclusion Criteria:\n\n* Carcinomatous meningitis confirmed by a positive CRL cytology or highly suspicious brain MRI.\n* Previous malignancies except for any carcinoma in-situ\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 condition 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.",{"count":64,"type":20},45,"INTERVENTIONAL",[67,68],"PHASE1","PHASE2","This interventional study aims to determine the pharmacokinetics of orally administered alectinib with dose escalation from 300 mg to 600 mg twice daily in Mexican patients with advanced ALK-positive NSCLC.\n\nThe main question it aims to answer is: what will be the peak plasma concentrations of alectinib following sequential dose escalation (300, 450, and 600 mg BID) over nine weeks of pharmacokinetic evaluation (phase I) in Mexican patients with advanced ALK-rearranged NSCLC?\n\nIn phase I (on days 0, 21, and 42), oral alectinib will be administered twice per day (BID) to patients with ALK-positive NSCLC; starting with 300 mg BID in 21-day cycles and dose escalation in 150 mg increments until 600 mg BID. Blood samples will be taken before and after administration of each dose (on days 1, 22, and 43). The primary endopoints in phase I will be dose-limiting toxicity (DLT) and PK parameters (Cmax. maximum plasma concentration; Tmax: time to reach maximum concentration: AUC 1-12: area under plasma ocncentrations-time curve steady-state concentration). At the end of the last blood collection (at day 43), the evaluation of each cycle will be at 600 mg, and the participant will be discharged to continue their treatment on an outpatient basis. Phase one will finish on day 63 of the study.\n\nIn phase II, the chosen BID dose based on the phase I portion will be administrated until disease progression, development of unacceptable side effects, or withdrawal of consent. The primary endpoint in phase 2 is the overall response rate (ORR) per RECIST V.1.1.",[71,27],"Non-small Cell Lung Cancer Stage IIIB",[73,74,75],"alectinib","positive-ALK","non small cell lung cancer","RECRUITING","2026-04-06",{"date":79,"type":47},"2026-04-08",{"date":81,"type":47},"2022-05-01",{"date":83,"type":20},"2027-12-01",{"name":85,"class":54},"Instituto Nacional de Cancerologia de Mexico",{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":93,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":55},"100289013","early-rebiopsy-to-identify-biomarkers-of-tumor-cell-survival-following-egfr-alk-ros1-or-braf-tki-therapy-100289013","NCT03042221","Early Rebiopsy to Identify Biomarkers of Tumor Cell Survival Following EGFR, ALK, ROS1 or BRAF TKI Therapy","Early Rebiopsy to Identify Mechanisms and Biomarkers of Tumor Cell Survival Following Systemic Therapy for Lung Cancer","Inclusion Criteria:\n\nTargetable Oncogene - Biopsy Cohort (includes blood draw)\n\n1. Carry a diagnosis of locally advanced or stage IV NSCLC responsive to targeted therapies (per current NCCN guidelines)\n2. Aged 18 years or older\n3. ECOG 0-2\n4. Have a histologically confirmed diagnosis of NSCLC harboring an activating mutation responsive to targeted therapy (per NCCN guidelines)\n5. No prior systemic therapy for locally advanced or metastatic disease.\n6. Planned treatment with targeted therapy specific to the oncogene driver mutation.\n7. Patients must have at least one site of measurable disease ≥ 2cm.\n8. Primary disease site or site of metastatic disease must be amenable to biopsy.\n9. Patients must have the ability to understand and willingness to sign an informed consent document.\n\nTargetable Oncogene - Blood Draw Only Cohort\n\n1. Carry a diagnosis of locally advanced or stage IV NSCLC responsive to targeted therapy (per NCCN guidelines)\n2. Aged 18 years or older\n3. ECOG 0-2\n4. Have a histologically confirmed diagnosis of NSCLC harboring an activating mutation responsive to targeted therapy (per NCCN guidelines)\n5. No prior systemic therapy or radiotherapy for metastatic lung cancer (surgery alone permitted)\n6. Planned treatment with targeted therapy specific to the oncogene driver mutation.\n7. Declines repeat biopsy option or does not have tumor site amenable to biopsy.\n8. Patients must have the ability to understand and willingness to sign an informed consent document.\n\nImmunotherapy Cohort - Blood Draw Only\n\n1. Have a histologically confirmed diagnosis of locally advanced or stage IV NSCLC without a treatable activating mutation that would be amenable to targeted therapy AND planned first line treatment with immunotherapy or chemotherapy plus immunotherapy.\n2. Aged 18 years or older\n3. ECOG 0-2\n4. No prior systemic therapy or radiation therapy for lung cancer (surgery alone permitted)\n5. Patients must have the ability to understand and willingness to sign an informed consent document.\n\nExclusion Criteria:\n\nTargetable Oncogene - Biopsy Cohort (includes blood draw)\n\n1. Concurrent health problem which would preclude tissue biopsy (e.g. hemophilia or other bleeding predisposition).\n2. Patients whose only biopsy source would involve sampling an anatomic area that carries an unacceptably high procedural risk (e.g. pericardium or kidney) as deemed by the treating physician or by a proceduralist performing the biopsy.\n3. Patients whose only biopsy source involves a sample that may not be evaluable due to insufficient genomic material (such as cerebrospinal or ascitic fluid) as deemed by the treating physician. .\n\nTargetable Oncogene Cohort and Immunotherapy Cohort - Blood Draw Only\n\n1. Planned follow up on therapy outside of the University of Colorado Health System\n2. Unwillingness to allow for residual clinical biopsy specimens to be utilized in this study.","85 Years",{"count":95,"type":20},100,"A comparison of baseline tumor characteristics in oncogene-driven cancers to tumor characteristics after early response to Tyrosine Kinase Inhibitor (TKI) targeted treatment will allow identification of early adaptive mechanisms of cell survival. This will facilitate targeting and termination of these survival\u002F resistance pathways before they develop with rational combinations of therapeutic agents to improve outcomes.",[98,99,100,27,101,102],"Non-Small Cell Carcinoma of Lung, TNM Stage 4","Non-Small Cell Lung Cancer","EGFR Gene Mutation","ROSE Cluster 1","BRAF V600E","2026-02-18",{"date":105,"type":47},"2026-02-20",{"date":107,"type":47},"2016-05-10",{"date":109,"type":20},"2027-09-30",{"name":111,"class":54},"University of Colorado, Denver",{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":65,"phases":122,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":55},"100387296","phase-2-treatment-strategies-and-survival-outcome-for-non-small-cell-lung-cancer-with-oncogenic-mutation-100387296","NCT04322890","Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation","Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation.","PIKACHU","Inclusion Criteria:\n\n1. Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.\n2. Age ≥ 18 years.\n3. Histologically or cytologically confirmed, Stage IV NSCLC.\n4. Oncogenic mutations confirmed by an accredited local laboratory, including EGFR, ALK, ROS1 etc.\n5. ECOG 0-1.\n6. Predicted survival ≥ 12 weeks.\n7. Adequate bone marrow hematopoiesis and organ function\n8. Presence of measurable lesions according to RECIST 1.1.\n\nExclusion Criteria:\n\nThe patient did not match from the Inclusion Criteria.",{"count":121,"type":20},6000,[68],"The purpose of this study is to assess the Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation.",[125,100,27,126,127],"Non Small Cell Lung Cancer","ROS1 Gene Mutation","MET Gene Mutation","2024-10-19",{"date":130,"type":47},"2024-10-22",{"date":132,"type":47},"2020-04-16",{"date":134,"type":20},"2027-12-24",{"name":136,"class":54},"Hunan Province Tumor Hospital",{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":147,"conditions":148,"keywords":151,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":55},"100534111","longitudinal-assessment-of-genomic-alterations-and-clonal-evolution-in-alk-positive-nsclc-galileo-project-100534111","NCT06234579","Longitudinal Assessment of Genomic Alterations and Clonal Evolution in ALK-positive NSCLC (Galileo Project)","\"GALILEO (Genomic ALteratIons and cLonal EvOlution in ALK+ NSCLC) - Valutazione Longitudinale Delle Alterazioni Genomiche e Clonali Nei Pazienti Affetti da Neoplasie Polmonari ALK-riarrangiate\".","GALILEO","Inclusion Criteria:\n\n* a) histologically confirmed diagnosis of advanced NSCLC with ALK rearrangement detection by NGS (ALK+ NSCLCs patients detected at diagnosis by in hybridization (FISH), immunohistochememistry (IHC), or reverse transcriptase-PCR (RT-PCR) can be included if adequate tissue for NGS is available)\n\n  b) to have received upfront treatment with alectinib, brigatinib or lorlatinib for at least 28 days\n\n  c) ECOG PS 0-2\n\n  d) adult patients (aged ≥ 18 years) at the moment of diagnosis\n\n  e) signing of informed consent approved by the local Ethic Committee\n\nExclusion Criteria:\n\na) Diagnosis of lung cancer without ALK rearrangement\n\na) early withdrawn of treatment due to toxicity without evidence of radiological disease progression cannot be eligible for the study",{"count":146,"type":20},108,"The scope of GALILEO project (Genomic ALteratIons and cLonal EvOlution in ALK+ NSCLC) is to explore the feasibility of genomic longitudinal evaluation for ALK+ NSCLC patients in Italian routine practice and provide a detailed overview of resistance mechanisms and clinical outcomes according to current standard treatments.",[27,149,150],"NSCLC Stage IV","ALK Sensitizing Mutation",[152,153],"ALK mutation","NSCLC","2024-07-29",{"date":156,"type":47},"2024-07-31",{"date":158,"type":47},"2021-07-12",{"date":160,"type":20},"2026-07-31",{"name":162,"class":54},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":65,"phases":173,"briefSummary":174,"conditions":175,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":55},"100459763","phase-2-pembrolizumab-plus-bevacizumab-and-chemotherapy-for-alk-rearranged-nsclc-with-persistent-5alk-100459763","NCT05266846","Pembrolizumab Plus Bevacizumab and Chemotherapy for ALK-rearranged NSCLC With Persistent 5'ALK","Bevacizumab and Chemotherapy With or Without Pembrolizumab in First Line Alectinib Failed ALK-rearranged Advanced Lung Adenocarcinoma Patients With Persistent 5'ALK: A Phase II Randmized Control Trial","BEYOND","Inclusion Criteria:\n\n* Age ≥ 18 years of age on day of signing informed consent.\n\n  * Stage IV ALK-rearranged Lung Adenocarcinoma Persistent with 5'ALK Failed from first line Alectinib\n\n    * Have at least 1 lesion that meets the criteria for being measurable, as defined by RECIST 1.1, and is appropriate for selection as a target lesion, as determined by local site investigator radiology review. Lesions that appear measurable, but have undergone palliative irradiation, cannot be target lesions ④20 FFPE sliders prepared,Subjects who do not have histology samples (defined as core or excisional biopsy, or resections) will need to undergo a new biopsy to provide a tissue sample ⑤Eastern Cooperative Oncology Group performance status 0 or 1\n\n      * Life expectancy ≥3 months\n\n        * Adequate hematologic and end organ function\n\nExclusion Criteria:\n\nCancer-Specific Exclusions:\n\n①Active or untreated central nervous system metastases\n\n②Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome\n\nGeneral Medical Exclusions:\n\n* Pregnant or lactating women.\n\n  * Has active autoimmune disease that has required systemic treatment in the past 2 years.\n\n    * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n\n      * Positive test for human immunodeficiency virus.\n\n        ⑤Active hepatitis B or hepatitis C.\n\n        ⑥Severe infection within 4 weeks prior to randomization .\n\n        ⑦Significant cardiovascular disease.\n\n        ⑧Illness or condition that interferes with the participant's capacity to understand, follow and\u002For comply with study procedures.\n\n        ⑨Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment for another health-related problem.\n\nExclusion Criteria Related to Medications: Prior treatment with anti-programmed death-1, anti-PD-L1 therapeutic antibodies，and anti-VEGF agents.",{"count":172,"type":20},78,[68],"This is an open-label, multiple centers, two-arms phase II study to evaluate the safety and efficacy Pembrolizumab,Bevacizumab in combination with Chemotherapy could improve PFS in Alectinib Failed ALK-rearranged Advanced Lung Adenocarcinoma with Persistent 5'ALK. The eligible patients should have Stage IV Adenocarcinoma ALK-rearranged tested by NGS Perisitent with 5'ALK Failed from first line Alectinib. The patients should meet the physical requirements to receive Pembrolizumab, Bevacizumab with Chemotherapy. All the patients who meet these requirements will be enrolled in this study. The eligible patients will be treated with Pembrolizumab 200 mg intravenously (IV) plus Bevacizumab 15mg\u002Fkg+ Pemetrexed 500mg\u002Fm2+Carboplatin AUC=4 for up to 4 cycles followed by Pembrolizumab 200mg Q3W+ Bevacizumab 15mg\u002Fkg+Pemetrexed 500mg\u002Fm2 for up to 31cycles or until disease progression, intolerable toxicity, or physician or participant decision.",[27,176,177],"Lung Adenocarcinoma","Immunotherapy","2024-05-28",{"date":180,"type":47},"2024-05-30",{"date":182,"type":47},"2024-05-29",{"date":184,"type":20},"2027-02-16",{"name":136,"class":54},{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":192,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":194,"targetDuration":4,"studyType":65,"phases":195,"briefSummary":196,"conditions":197,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":208},"100545207","phase-2-a-study-to-evaluate-the-combination-of-platinum-pemetrexed-based-chemotherapy-plus-lorlatinib-in-alk-positive-non-small-cell-lung-cancer-nsclc-with-exclusively-extracranial-disease-progression-on-lorlatinib-100545207","NCT06378892","A Study to Evaluate the Combination of Platinum-pemetrexed Based Chemotherapy Plus Lorlatinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) With Exclusively Extracranial Disease Progression on Lorlatinib","A Multicenter Single-arm Phase II Interventional Study to Evaluate the Activity and Safety of the Combination of Platinum-pemetrexed Based Chemotherapy Plus Lorlatinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) With Exclusively Extracranial Disease Progression on Lorlatinib.","ALK-PPL","Key Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of stage IV ALK positive NSCLC.\n* Patients must be in progression extracranially on Lorlatinib; Lorlatinib may be in first- or further-line, without limitations regarding previously received therapies.\n* Age at the time of signing the informed consent at least 18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n* Patients must have measurable disease according to RECIST 1.1 by computed tomography (CT) and magnetic resonance imaging (MRI).\n* Radiologically confirmed multiple extracranial progression on Lorlatinib without progression in the central nervous system (CNS) defined as absence of CNS metastasis or CNS metastasis stable on Lorlatinib and\u002For stereotactic brain irradiation (SBRT).\n* Adequate organ function (kidney, bone marrow and liver).\n* Estimated life expectancy of at least 3 months irrespective of the diagnosis of ALK+ NSCLC.\n* For women of childbearing potential and males with partners of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \\\u003C 1% per year during the treatment period and for at least 6 months after the last dose of study drugs.\n\nKey Exclusion Criteria:\n\n* Known hypersensitivity reaction to one of the compounds or substances used in this protocol.\n* Diagnosis of any secondary malignancy within the last 3 years except for: adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, definitively treated nonmetastatic prostate cancer or patients with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy.\n* Patients deemed unsuitable by the investigator for treatment of chemo-Lorlatinib combination.\n* Presence of toxicities contraindicating the continuation of therapy with Lorlatinib.\n* Concomitant use of potent CYP3A4\u002F5 inducers.\n\nOther inclusion\u002Fexclusion criteria may apply.",{"count":64,"type":20},[68],"This study aims to evaluate the activity and safety of the combination of platinum-pemetrexed based chemotherapy plus Lorlatinib in ALK positive Non-Small Cell Lung Cancer (NSCLC) with exclusively extracranial disease progression on Lorlatinib. Platinum-pemetrexed based chemotherapy plus Lorlatinib will be administered for an induction phase of four cycles. Subsequently, patients with response or stability of disease at radiological assessment will start the maintenance phase with pemetrexed-Lorlatinib in 21-day cycles until progression, unacceptable toxicity, death, or withdrawal of consent.",[198,27],"Non Small Cell Lung Cancer Metastatic","2024-04-22",{"date":201,"type":47},"2024-04-23",{"date":203,"type":47},"2024-03-15",{"date":205,"type":20},"2028-05",{"name":207,"class":54},"Centro di Riferimento Oncologico - Aviano",9,{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":215,"eligibilityCriteria":216,"healthyVolunteers":11,"sex":16,"minAge":217,"maxAge":4,"enrollmentInfo":218,"targetDuration":4,"studyType":65,"phases":220,"briefSummary":222,"conditions":223,"keywords":226,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":55},"100494886","alectinib-followed-by-concomitant-consolidation-radiation-therapy-in-advanced-nsclc-with-alk-rearrangement-a-sab-100494886","NCT05724004","Alectinib Followed by Concomitant Consolidation Radiation Therapy in Advanced NSCLC With ALK-rearrangement (A-SAB)","A-SAB - Alectinib Followed by Concomitant Consolidation SBRT\u002FHypofractionated Radiation Therapy\u002FSRS in Advanced NSCLC With ALK-rearrangement","A-SAB","Inclusion Criteria:\n\n1. Histological or cytological confirmed NSCLC:\n\n   * Stage IV NSCLC OR\n   * Stage III NSCLC not suitable for surgery or radiochemotherapy OR\n   * Recurrent NSCLC after previous surgery (not amendable for curative multimodal therapy)\n2. ALK-rearrangement\n3. Adequate organ function to tolerate alectinib and clinical tolerance to alectinib\n4. Stable disease (SD) or partial response (PR) after 2-3 months induction treatment with alectinib\n5. Maximum 5 tumour lesions +\u002F- thoracic lymph nodes active on an 18F-FDG-PET scan post induction treatment with alectinib\n6. All active tumour lesions amendable to RT under the following conditions:\n\n   * All metastases possible to treat with\n\n     * Extracranial metastases: SBRT of at least 7 Gy x 5 (corresponding to 50 Gy EQD2 using alfa\u002Fbeta 10Gy)\n     * Intracranial metastases: SRS or f-SRS\n   * The primary tumour and\u002For lymph nodes and\u002For pulmonary metastases amendable to SBRT (≥ 7Gy x 5, see above) or moderately hypofractionated RT of 3 Gy x 15 (corresponding to 49 Gy EQD2 using alfa\u002Fbeta 10Gy)\n7. Adequate organ function to tolerate SBRT\u002FRT:\n\n   * Fulfilment of dose constraints to adequate organs at risk\n8. ECOG performance status (PS) 0-2\n9. FEV1 ≥1 litre (only applicable for lung targets)\n10. Age ≥ 20 years\n11. Measurable lesions according to RECIST v 1.1\n12. Signed written informed consent\n\nExclusion Criteria:\n\n1. Leptomeningeal carcinosis (on MRI or in cerebrospinal fluid (CSF))\n2. Persistent malignant pleural effusion, malignant pericardial effusion or malignant ascites after induction treatment\n3. PD after 2-3-month-induction treatment with alectinib\n4. Previous TKI, chemotherapy or immunotherapy (previous adjuvant chemotherapy for early stage NSCLC is allowed) for metastatic NSCLC\n5. Previous RT for NSCLC (any stage)\n6. Previous RT for any other cancer within the last 3 years possibly interfering with the planned RT within this study\n7. Life expectancy of less than 6 months\n8. Inability to understand given information or undergo study procedures according to protocol.\n9. Has evidence or a past medical history of interstitial lung disease or active, non-infectious pneumonitis or known pulmonary fibrosis.\n10. Pregnant or breast-feeding. Patients must agree to use safe contraception during and for 3 months after study treatment.","20 Years",{"count":219,"type":20},70,[221],"NA","The goal of this clinical trial is to learn evaluate the safety and efficacy of the addition of radiation therapy to all tumour lesions, to first line medical treatment with alectinib in non-small cell lung cancer harbouring ALK-rearrangements.\n\nThe main aims of the trial are to evaluate:\n\n* if the treatment combination is safe\n* if the treatment combination can inhibit progression\n\nParticipants who have responded to 1st line alectinib will be treated with consolidation radiation therapy to all remaining tumour lesions while continuing on alectinib until disease progression, unacceptable toxicity or another discontinuation criterion is met.",[224,225,27],"Radiotherapy Side Effect","Non-small Cell Lung Cancer",[227,228,229,225,230],"Stereotactic body radiation therapy","SBRT","Radiotherapy","ALK-rearrangement","2023-10-06",{"date":233,"type":47},"2023-10-10",{"date":235,"type":47},"2023-10-05",{"date":237,"type":20},"2031-06-20",{"name":239,"class":54},"Karolinska University Hospital"]