[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Nuvalent Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":168},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,51,72,87,100,126,147],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100053250","phase-3-neladalkib-nvl-655-for-tki-naive-patients-with-advanced-alk-positive-nsclc-100053250",false,"NCT06765109","Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC","A Phase 3 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 Compared to Alectinib in First-Line Treatment of Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer (ALKAZAR)","ALKAZAR","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed locally advanced (not amenable for multimodality treatment) or metastatic Non-small Cell Lung Cancer (NSCLC)\n2. Documented Anaplastic Lymphoma Kinase (ALK) rearrangement via testing of tissue or blood\n3. No prior systemic anticancer treatment for NSCLC (adjuvant\u002Fneoadjuvant chemotherapy allowed if 12 months prior to randomization; prior ALK tyrosine kinase inhibitor \\[TKI\\] such as alectinib is not allowed in any setting)\n4. Measurable disease (1 or more target lesions per Response Evaluation Criteria in Solid Tumors \\[RECIST\\] 1.1)\n5. Pretreatment tumor tissue\n\nExclusion Criteria:\n\n1. Patient's cancer has a known oncogenic driver alteration other than ALK.\n2. Known allergy\u002Fhypersensitivity to excipients of neladalkib or alectinib.\n3. Ongoing or recent radiotherapy as per protocol-specified timeframes prior to randomization\n4. Major surgery within 4 weeks prior to randomization\n5. Uncontrolled clinically relevant infection requiring systemic therapy\n6. Known active tuberculosis, or active Hepatitis B or C\n7. QT corrected for heart rate by Fridericia's formula (QTcF) \\> 470 msec on repeated assessments\n8. Clinically significant cardiovascular disease\n9. Brain metastases associated with progressive neurological symptoms or requiring increasing doses of corticosteroids to control CNS disease\n10. Active malignancy requiring therapy within 2 years prior to randomization","ALL","18 Years",{"count":20,"type":21},450,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Multicenter, randomized, controlled, open-label, Phase 3 study designed to demonstrate that neladalkib (NVL-655) is superior to alectinib in prolonging progression-free survival (PFS) in patients with treatment-naïve, Anaplastic Lymphoma Kinase (ALK) positive, advanced Non-Small Cell Lung Cancer (NSCLC).",[27,28],"Non-small Cell Lung Cancer","Anaplastic Lymphoma Kinase-positive",[30,31,32,33,34,35,36,37],"NSCLC","Lung cancer","Lung neoplasms","Lung diseases","ALK positive NSCLC","TKI naive","ALK TKI naive","Treatment naive","RECRUITING","2026-07-10",{"date":41,"type":42},"2026-07-13","ACTUAL",{"date":44,"type":42},"2025-07-17",{"date":46,"type":21},"2029-12",{"name":48,"class":49},"Nuvalent Inc.","INDUSTRY",156,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":70,"locationsCount":71},"100580190","expanded-access-program-of-neladalkib-nvl-655-for-patients-with-advanced-alk-nsclc-or-other-alk-solid-tumors-100580190","NCT06834074","Expanded Access Program of Neladalkib (NVL-655) for Patients With Advanced ALK+ NSCLC or Other ALK+ Solid Tumors","Expanded Access Treatment of Neladalkib (NVL-655) in Patients With Advanced ALK+ NSCLC or Other ALK+ Solid Tumors","NVL-655-EAP","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC or other solid tumors with a documented ALK rearrangement or activating ALK mutation.\n3. Previously received at least one ALK TKI (for patients with NSCLC) or any prior therapy (for patients with other solid tumors), with no comparable or satisfactory alternative treatment options, in the opinion of the treating physician.\n4. Enrollment in a clinical trial of neladalkib is not possible.\n5. Adequate organ function and bone marrow reserve.\n\nExclusion Criteria:\n\n1. Prior receipt of neladalkib.\n2. Previous surgery, chemotherapy, radiotherapy or other anti-cancer therapy or participation in other studies within timeframe indicated in the protocol.\n3. Ongoing anti-cancer therapy.","EXPANDED_ACCESS","The Expanded Access Program will provide an alternate mechanism for patients, who lack satisfactory therapeutic alternatives and cannot participate in a neladalkib clinical trial, to access investigational neladalkib.",[62,63],"Non Small Cell Lung Cancer","ALK-positive Non-small Cell Lung Cancer (NSCLC)",[65],"ALK-positive Solid Tumors","AVAILABLE","2026-06-18",{"date":69,"type":42},"2026-06-23",{"name":48,"class":49},46,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":85,"locationsCount":86},"100577366","expanded-access-program-of-zidesamtinib-nvl-520-for-patients-with-advanced-ros1-nsclc-or-other-ros1-solid-tumors-100577366","NCT06797362","Expanded Access Program of Zidesamtinib (NVL-520) for Patients With Advanced ROS1+ NSCLC or Other ROS1+ Solid Tumors","Expanded Access Treatment of Zidesamtinib (NVL-520) in Patients With Advanced ROS1+ NSCLC or Other ROS1+ Solid Tumors","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC or other solid tumor with documented ROS1 rearrangement.\n3. Previously received at least 1 prior ROS1 TKI, with no comparable or satisfactory alternative treatment options, in the opinion of the treating physician.\n4. Enrollment in a clinical trial of zidesamtinib is not possible.\n5. Adequate organ function and bone marrow reserve.\n\nExclusion Criteria:\n\n1. Prior receipt of zidesamtinib.\n2. Previous surgery, chemotherapy, radiotherapy or other anti-cancer therapy or participation in other studies within timeframe indicated in the protocol.\n3. Ongoing anti-cancer therapy.\n4. Eligible for ongoing clinical trial with zidesamtinib","The Expanded Access Program will provide an alternate mechanism for these patients, who lack satisfactory therapeutic alternatives and cannot participate in a zidesamtinib clinical trial, to access investigational zidesamtinib.",[62,81],"ROS1-positive Non-Small Cell Lung Cancer (NSCLC)","2026-06-11",{"date":84,"type":42},"2026-06-15",{"name":48,"class":49},37,{"id":88,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":25,"conditions":91,"keywords":92,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":97,"leadSponsor":98,"locationsCount":99},"100574886",{"count":20,"type":21},[24],[27,28],[30,31,32,33,34,35,36,37],"2026-05-29",{"date":95,"type":42},"2026-06-02",{"date":44,"type":42},{"date":46,"type":21},{"name":48,"class":49},155,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":17,"minAge":107,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":22,"phases":110,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},"100468810","phase-1-a-study-of-neladalkib-nvl-655-in-patients-with-advanced-nsclc-and-other-solid-tumors-harboring-alk-rearrangement-or-activating-alk-mutation-alkove-1-100468810","NCT05384626","A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)","A Phase 1\u002F2 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 in Patients With Advanced NSCLC and Other Solid Tumors (ALKOVE-1)","Inclusion Criteria:\n\n1. Age ≥18 years, Phase 2 Cohort 2f only: Age ≥12 years and weighing \\>40 kg. DDI sub-study Cohorts G and H only: age 18-60 years, inclusive\n2. Phase 1: Histologically or cytologically confirmed locally advanced or metastatic solid tumor with a documented ALK rearrangement or activating ALK mutation.\n3. Phase 2\n\n   1. Phase 2 Cohorts except 2f: Histologically or cytologically confirmed locally advanced or metastatic NSCLC with a documented ALK rearrangement\n   2. Phase 2 Cohort 2f: Histologically or cytologically confirmed locally advanced or metastatic solid tumor with a documented ALK rearrangement or activating ALK mutation detected by certified assay.\n4. DDI sub-study cohorts: Histologically or cytologically confirmed locally advanced or metastatic NSCLC with a documented ALK rearrangement\n5. DDI sub-study cohorts: Must have previously received ≥1 ALK TKI; no prior investigational agents targeting ALK; any number of prior chemotherapy and\u002For immunotherapy\n6. Phase 1: Must have evaluable disease (target or nontarget) according to RECIST 1.1 Phase 2: Must have measurable disease according to RECIST 1.1\n7. Adequate organ function and bone marrow reserve\n\nExclusion criteria:\n\n1. Patient's cancer has a known oncogenic driver alteration other than ALK.\n2. Known allergy\u002Fhypersensitivity to excipients of NVL-655.\n3. Major surgery within 4 weeks of the study entry\n4. Ongoing or anticancer therapy\n5. Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study.","12 Years",{"count":109,"type":21},840,[111,112],"PHASE1","PHASE2","Phase 1\u002F2, dose escalation and expansion study designed to evaluate the safety and tolerability of neladalkib (NVL-655), determine the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced ALK- positive (ALK+) NSCLC and other solid tumors.\n\nPhase 1 will evaluate the overall safety and tolerability of neladalkib and will determine the RP2D and, if applicable, the maximum tolerated dose (MTD) of neladalkib in patients with advanced ALK+ solid tumors.\n\nPhase 2 will determine the objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) of neladalkib at the RP2D. Secondary objectives will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and clinical benefit rate (CBR) of neladalkib in patients with advanced ALK-positive NSCLC and other solid tumors.\n\nA drug-drug interaction (DDI) sub-study will determine the effect of neladalkib on the pharmacokinetics of midazolam and repaglinide, as well as the effect of itraconazole on the pharmacokinetics of neladalkib, in patients with advanced ALK-positive NSCLC",[115,116],"Locally Advanced Solid Tumor","Metastatic Solid Tumor","2026-05-22",{"date":119,"type":42},"2026-05-27",{"date":121,"type":42},"2022-06-09",{"date":123,"type":21},"2028-01",{"name":48,"class":49},74,{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":22,"phases":135,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},"100556166","phase-1-a-study-of-nvl-330-in-patients-with-advanced-or-metastatic-her2-altered-nsclc-heroex-1-100556166","NCT06521554","A Study of NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1)","A Phase 1a\u002F1b Study of the Selective Tyrosine Kinase Inhibitor NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1)","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC\n3. Documented HER2 status as follows:\n\n   1. Phase 1a: Documented oncogenic HER2 mutation such as HER2 exon20 insertion mutations or single nucleotide variants or HER2 amplification.\n   2. Phase 1b: Documented oncogenic HER2 mutation.\n4. Identification of lesions as follows:\n\n   1. Phase 1a: Must have evaluable disease (target or nontarget) according to RECIST 1.1.\n   2. Phase 1b: Must have measurable disease, defined as ≥ 1 radiologically measurable target lesion according to RECIST 1.1.\n5. Adequate organ function and bone marrow reserve\n\nExclusion Criteria:\n\n1. Participant's cancer has known oncogenic driver alteration other than HER2\n2. Known allergy\u002Fhypersensitivity to excipients of NVL-330\n3. Major surgery within 4 weeks of the first dose of study drug\n4. Ongoing or recent anticancer therapy\n5. Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study",{"count":134,"type":21},200,[111],"Phase 1a\u002F1b dose escalation and expansion study designed to evaluate the safety and tolerability of NVL-330, determine the recommended Phase 2 dose (RP2D), and evaluate the antitumor activity in participants with advanced or metastatic human epidermal growth factor receptor 2 (HER2) -altered non-small lung cancer (NSCLC).\n\nPhase 1a dose escalation is designed to assess the safety and tolerability of NVL-330 and to select the candidate RP2D(s) and, if applicable, the MTD.\n\nPhase 1b expansion is designed to further evaluate the overall safety and tolerability of the candidate RP2D(s) of NVL-330 and to determine the RP2D of NVL-330 in participants with advanced or metastatic HER2 mutant NSCLC.",[115,116],"2026-02-23",{"date":140,"type":42},"2026-02-25",{"date":142,"type":42},"2024-07-18",{"date":144,"type":21},"2027-02",{"name":48,"class":49},21,{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":17,"minAge":107,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":22,"phases":156,"briefSummary":157,"conditions":158,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":167},"100448387","phase-1-a-study-of-zidesamtinib-nvl-520-in-patients-with-advanced-nsclc-and-other-solid-tumors-harboring-ros1-rearrangement-arros-1-100448387","NCT05118789","A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)","A Phase 1\u002F2 Study of the Highly Selective ROS1 Inhibitor Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors (ARROS-1)","Inclusion Criteria:\n\n1. Age ≥18 years (Cohort 2e only: Age ≥12 years).\n2. Disease Criteria:\n\n   1. Phase 1: Histologically or cytologically confirmed locally advanced or metastatic solid tumor with documented ROS1 rearrangement.\n   2. Phase 2: Cohorts 2a, 2b, 2c and 2d: Histologically or cytologically confirmed locally advanced or metastatic NSCLC with ROS1 rearrangement.\n   3. Phase 2: Cohort 2e: Histologically or cytologically confirmed locally advanced or metastatic solid tumor (other than NSCLC) with ROS1 rearrangement.\n3. Prior anticancer treatment (except cohort 2a).\n4. Phase 1: Must have evaluable disease (target or nontarget) according to RECIST 1.1. Phase 2: Must have measurable disease according to RECIST 1.1.\n5. Adequate baseline organ function and bone marrow reserve.\n\nExclusion Criteria:\n\n1. Patient's cancer has a known oncogenic driver alteration other than ROS1.\n2. Known allergy\u002Fhypersensitivity to excipients of NVL-520.\n3. Major surgery within 4 weeks of first dose of study drug.\n4. Ongoing anticancer therapy.\n5. Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study.",{"count":155,"type":21},359,[111,112],"Phase 1\u002F2, dose escalation and expansion study designed to evaluate the safety and tolerability of zidesamtinib (NVL-520), determine the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced ROS1-positive (ROS1+) NSCLC and other advanced ROS1-positive solid tumors.\n\nPhase 1 will determine the RP2D and, if applicable, the maximum tolerated dose (MTD) of zidesamtinib in patients with advanced ROS1-positive solid tumors.\n\nPhase 2 will determine the objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) of zidesamtinib at the RP2D. Secondary objectives will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and clinical benefit rate (CBR) of zidesamtinib in patients with advanced ROS1-positive NSCLC and other solid tumors.",[115,116],"2025-10-22",{"date":161,"type":42},"2025-10-24",{"date":163,"type":42},"2022-01-04",{"date":165,"type":21},"2028-12-31",{"name":48,"class":49},63,""]