[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"1st-line-nsclc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:1st-line-nsclc":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":26,"conditions":27,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100446799","phase-1-study-of-stk-012-alone-and-with-other-treatments-in-patients-with-advanced-lung-cancer-and-other-cancers-100446799",false,"NCT05098132","Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers","A Phase 1\u002F2 Study to Evaluate STK-012 as a Single Agent and in Combination Therapy in Subjects With Front-line Advanced NSCLC and Other Selected Indications","SYNERGY-101","Selected Inclusion Criteria:\n\n1. Phase 1: Selected advanced solid tumors\n2. Phase 2:\n\n   * Diagnosis of non-small cell lung cancer (NSCLC).\n   * Stage IV or Stage IIIB\u002FIIIC and not a candidate for definitive treatment.\n   * Non-squamous (NSQ) cell histology.\n   * No prior systemic therapy for advanced\u002Fmetastatic NSQ NSCLC.\n   * Must have a tumor that meets at least one of the following criteria on local testing:\n\n     * PD-L1 negative (TPS \\\u003C1%), OR;\n     * STK11 mutated on tumor tissue or ctDNA\n   * No known actionable EGFR, ALK, ROS1, or other actionable genomic aberrations for which there is a local standard of care available as front line therapy.\n\nSelected Exclusion Criteria:\n\n2\\. Phase 2:\n\n* Prior immune checkpoint inhibitor (anti-PD\\[L\\]1 and\u002For anti-CTLA-4) treatment\n* Rare tumor subtypes (mucinous histology or tumors with small cell, neuroendocrine, or sarcomatoid components).\n* Received radiotherapy ≤ 7 days of the first dose of study treatment.\n* Known active central nervous system metastases\n* Any history of carcinomatous meningitis","ALL","18 Years",{"count":20,"type":21},364,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This is a phase 1\u002F2, multicenter, open-label study. The phase 1 portion is a dose escalation and expansion study of STK-012 as monotherapy and in combination therapy in patients with selected advanced solid tumors. The phase 2 portion is a randomized study of STK-012 in combination with standard of care (SoC) pembrolizumab, pemetrexed, and carboplatin versus SoC, in patients with first line, PD-L1 negative or STK11 mutated, non-squamous, non-small cell lung cancer.",[28,29,30,31],"Advanced Solid Tumor","Non Small Cell Lung Cancer","Untreated Advanced NSCLC","1st Line NSCLC","RECRUITING","2026-06-24",{"date":35,"type":36},"2026-06-29","ACTUAL",{"date":38,"type":36},"2022-01-25",{"date":40,"type":21},"2029-01",{"name":42,"class":43},"Synthekine","INDUSTRY",47]