[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06905197":3,"trial-entities:NCT06905197":162,"trial-summary:NCT06905197":166},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":51,"secondary_outcomes":62,"sex":89,"minimum_age":90,"maximum_age":15,"healthy_volunteers":91,"eligibility_criteria":92,"std_ages":96,"locations":99,"central_contacts":154,"overall_officials":159,"references":160,"see_also_links":161},"NCT06905197","DZ2023C0001","A Multinational Study Assessing an Oral EGFR Inhibitor, DZD6008 in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN1)","A Phase 1, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy of DZD6008 in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations (TIAN-SHAN1)","RECRUITING","2028-12","2026-02","2026-02-27","2025-05-13","Dizal Pharmaceuticals","INDUSTRY",null,"This study is designed to evaluate safety and anti-tumor activity of DZD6008 in patients with advanced NSCLC with EGFR mutations.","The study includes two parts: Part A (dose escalation) and Part B (dose expansion). In Part A, locally advanced or metastatic NSCLC patients with EGFR mutations following at least 1 prior EGFR TKI regimen will be enrolled. In Part B, locally advanced or metastatic NSCLC patients with EGFR sensitizing mutations, who are previously treated with 1 line of third-generation of EGFR TKI treatment as well as treatment naïve will be enrolled.",[19],"Non Small Cell Lung Cancer",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE1",{"count":26,"type":27},140,"ESTIMATED",[29,47],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","DZD6008","Daily dose of DZD6008",[34,35,36,37,38,39,40,41,42,43,44,45,46],"Experimental: Experimental: Part A Dose Escalation Combination cohorts (Combination dose 1)","Experimental: Experimental: Part A Dose Escalation Combination cohorts (Combination dose 2)","Experimental: Experimental: Part B Dose Expansion cohort A2 (selected dose 2)","Experimental: Experimental: Part B Dose Expansion cohort B1 (selected dose 1)","Experimental: Experimental: Part B Dose Expansion cohort B2 (selected dose 2)","Experimental: Part A Dose Escalation Combination cohorts (Combination dose 3)","Experimental: Part A Dose Escalation monotherapy cohorts (120 mg QD)","Experimental: Part A Dose Escalation monotherapy cohorts (150 mg QD)","Experimental: Part A Dose Escalation monotherapy cohorts (20 mg once daily [QD])","Experimental: Part A Dose Escalation monotherapy cohorts (40 mg QD)","Experimental: Part A Dose Escalation monotherapy cohorts (60 mg QD)","Experimental: Part A Dose Escalation monotherapy cohorts (90 mg QD)","Experimental: Part B Dose Expansion cohort A1 (selected dose 1)",{"type":30,"name":48,"description":49,"armGroupLabels":50},"Sunvozertinib","Daily dose of Sunvozertinib",[34,35,39],[52,56,59],{"measure":53,"description":54,"timeFrame":55},"Part A: To assess safety and tolerability","Number of participants with Dose-limiting Toxicities (DLTs)","21 days after the first multiple dose",{"measure":53,"description":57,"timeFrame":58},"Number of participants with Adverse events (AEs)\u002FSerious adverse events (SAEs)","Through the study completion, an average of around 1 year",{"measure":60,"description":61,"timeFrame":58},"Part B: To assess anti-tumor activity","Objective Response Rate (ORR) assessed by investigators per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1",[63,67,71,74,76,78,81,83,86],{"measure":64,"description":65,"timeFrame":66},"Part A: To characterize the plasma concentration of DZD6008 following single and multiple oral dose administration","Total concentrations of DZD6008 in plasma","From first dosing to cycle 7 day 1, each cycle is 21 days",{"measure":68,"description":69,"timeFrame":70},"Part A: To characterize the plasma concentration of sunvozertinib and metabolite DZ0753 following single and multiple oral dose administration","Total concentrations of sunvozertinib and metabolite DZ0753 in plasma (combination cohorts only)","From first dosing to cycle 9 day 1, each cycle is 21 days",{"measure":72,"description":73,"timeFrame":58},"Part A: To assess the anti-tumor activity","ORR assessed by investigators per RECIST version 1.1",{"measure":72,"description":75,"timeFrame":58},"Duration of Response (DoR) assessed by investigators per RECIST version 1.1",{"measure":72,"description":77,"timeFrame":58},"Progression Free Survival (PFS) assessed by investigators per RECIST version 1.1",{"measure":79,"description":80,"timeFrame":58},"Part B: To assess the anti-tumor activity","DoR assessed by investigators per RECIST version 1.1",{"measure":79,"description":58,"timeFrame":82},"PFS assessed by investigators per RECIST version 1.1",{"measure":84,"description":65,"timeFrame":85},"Part B: Plasma concentration of DZD6008","Time Frame: From first dosing to cycle 11 day 1, each cycle is 21 days",{"measure":87,"description":88,"timeFrame":58},"Part B: To assess safety and tolerability","Number of participants with AEs\u002FSAEs","ALL","18 Years",false,{"inclusion":93,"exclusion":94,"raw_text":95},[],[],"Inclusion Criteria:\n\n1. Patients must be able to provide documented informed consent.\n2. Aged ≥ 18 years.\n3. Histologically or cytologically confirmed diagnosis of NSCLC, locally advanced or metastatic, not suitable for curative therapy.\n4. Documentation of EGFR mutations from a local CLIA-certified laboratory (or equivalent). For Part A monotherapy cohorts and all cohorts of Part B, EGFR sensitizing mutations (Exon19del and\u002For L858R) are required.\n5. Provide adequate amount of pretreatment tumor samples collected after disease progression on the last EGFR TKI treatment. (previously treated patients) or before study treatment (treatment naïve patients).\n6. Part A: Failed (progressed or are intolerant) from at least 1 prior EGFR TKI regimen. Cohort A of Part B: Failed 1 prior third-generation EGFR TKI regimen. Cohorts B of Part B: Patients who are treatment naïve.\n7. ECOG 0 or 1 with predicted life expectancy ≥ 12 weeks.\n8. Patients with brain metastases must have a stable BM status.\n9. Measurable disease per RECIST 1.1.\n10. Adequate hematopoietic and other organ system functions.\n11. Male Patients with female partners of childbearing potential should use barrier contraceptives and refrain from donating sperm during their participation in this study and for 3 months following the last dose of the study drug.\n\nExclusion Criteria:\n\n1. Carry other EGFR alterations than T790M and C797X, including but not limited to uncommon EGFR mutations (G719X, S768I, L861Q, exon 20 insertions mutations, etc.)(Part B).\n2. NSCLC with mixed small cell lung cancer (SCLC) or NSCLC with histologic SCLC transformation.\n3. Prior treatment with any of the following: 1)Immunotherapy or other antibody therapy within 4 weeks prior to the first administration; 2)Any cytotoxic chemotherapy, investigational drugs or other anticancer drugs from a previous treatment regimen or clinical study within 14 days prior to the first administration; 3)Radiotherapy with a limited field of radiation for palliation within 7 days of the first dose, radiation to more than 30% of the bone marrow or with a wide field of radiation within 28 days before screening; 4)Currently receiving or unable to stop drug or herbal supplements known to be potent inhibitors or inducers of cytochrome P450 (CYP)3A4. A washout period of at least 2 weeks for strong inhibitors and 3 weeks for strong inducers is required prior to the first study drug administration; 5)currently receiving or unable to stop drugs known to be CYP3A4 sensitive substrate with a narrow therapeutic index. A washout period of at least 14 days is required prior to the first study drug administration; 6)currently receiving or unable to stop drugs known to be proton pump inhibitors. A washout period of at least 7 days is required prior to the first study drug administration; 7)major surgery within 4 weeks of the first administration of DZD6008 or anticipated during the study period.\n4. Any unresolved toxicities from prior anti-cancer therapy greater than CTCAE Grade 1.\n5. Spinal cord compression or leptomeningeal metastasis.\n6. Patients with any other malignancy within 2 years of the first administration of study drug.\n7. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses as judged by investigator.\n8. Patients with active infection, including but not limited to HBV, HCV, HIV and active infection of COVID-19.\n9. Resting QTcF \\> 470 msec; Any clinically significant abnormalities in rhythm, conduction or morphology of resting ECG;Any factors that increase the risk of QTc prolongation.\n10. Past medical history of ILD or active ILD.\n11. Diseases which would preclude adequate absorption of DZD6008.\n12. Received a live vaccine within 2 weeks before the first administration of DZD6008.\n13. Women who are pregnant or breastfeeding.\n14. Hypersensitivity to active or inactive excipients of DZD6008 or sunvozertinib.\n15. Involvement in the planning and conduct of the study.\n16. Judgment by the investigator that the patient is unlikely to comply with study procedures",[97,98],"ADULT","OLDER_ADULT",[100,114,123,132,141],{"facility":101,"status":8,"city":102,"state":102,"zip":103,"country":104,"contacts":105,"geoPoint":111},"Laura and Isaac Perlmutter Cancer Center at NYU Langone Health","New York","10016","United States",[106],{"name":107,"role":108,"phone":109,"email":110},"Shum","CONTACT","1-347-978-5004","elaine.shum@nyulangone.org",{"lat":112,"lon":113},40.71427,-74.00597,{"facility":115,"status":8,"city":102,"state":102,"zip":116,"country":104,"contacts":117,"geoPoint":122},"Herbert Irving Comprehensive Cancer Center","10032",[118],{"name":119,"role":108,"phone":120,"email":121},"Shu","(212) 305-3997","cas2145@cumc.columbia.edu",{"lat":112,"lon":113},{"facility":124,"status":125,"city":126,"state":127,"zip":128,"country":104,"geoPoint":129},"Virginia Cancer Specialist (NEXT Oncology-Virginia)","ACTIVE_NOT_RECRUITING","Fairfax","Virginia","22031",{"lat":130,"lon":131},38.84622,-77.30637,{"facility":133,"status":125,"city":134,"state":135,"zip":136,"country":137,"geoPoint":138},"Blacktown Hospital","Blacktown","New South Wales","2148","Australia",{"lat":139,"lon":140},-33.76667,150.91667,{"facility":142,"status":143,"city":144,"state":135,"zip":145,"country":137,"contacts":146,"geoPoint":151},"Chris O'Brien Lifehouse","NOT_YET_RECRUITING","Camperdown","2050",[147],{"name":148,"role":108,"phone":149,"email":150},"Kao","61-2- 85140000","steven.kao@lh.org.au",{"lat":152,"lon":153},-33.88965,151.17642,[155],{"name":156,"role":108,"phone":157,"email":158},"Yifan Liu","86-21-61095854","yifan.liu@dizalpharma.com",[],[],[],{"nct_id":4,"conditions":163,"biomarkers":165},[164],"Lung Non-Small Cell Carcinoma",[],{"nct_id":4,"found":167,"summary":168,"prompt_version":178},true,{"design":169,"status":170,"heading":171,"summary":172,"follow_up":173,"word_count":174,"commitments":175,"compensation":176,"drugs_mentioned":177},"This study is an interventional study with a planned enrollment of 140 participants. It has two parts: Part A (dose escalation) and Part B (dose expansion).","completed","TIAN-SHAN1 Study: DZD6008 for Advanced NSCLC with EGFR Mutations","This study is testing a new oral medicine called DZD6008 for people with advanced non-small cell lung cancer (NSCLC) that has specific changes in the EGFR gene. It will also compare DZD6008 to another medicine called Sunvozertinib. The main goals are to see how safe DZD6008 is and how well it works to shrink tumors. To join, you must be at least 18 years old, have advanced NSCLC that can't be cured by other treatments, and have a confirmed EGFR gene mutation. The study is currently unclear about its recruitment status and plans to enroll about 140 people.","Safety and anti-tumor activity will be measured through the study completion, which is an average of around 1 year.",98,"Not specified in the trial record.","Not stated in the trial record.",[31,48],"v2"]