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Hospital of JFCR (Japanese Foundation for Cancer Research)","Koto-Ku",{"type":80,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100638512","phase-1-aqua07-in-patients-with-alk-positive-non-small-cell-lung-cancer-100638512",false,"NCT07617337","AQUA07 in Patients With ALK-Positive Non-Small Cell Lung Cancer","A Phase I, Open-Label, Multicenter, Dose Escalation and Cohort Expansion Study of AQUA07 Monotherapy and Combination Therapy in Patients With Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Age ≥ 18 years (or ≥ 20 years if required by local regulation) at time of signing Informed Consent Form\n* Previously treated with at least one ALK-TKI regardless of prior chemotherapy treatment (Patients who have received only crizotinib as prior ALK-TKI treatment will not be allowed.)\n* Histologically or cytologically (excluding sputum cytology) proven diagnosis of locally advanced unresectable or metastatic ALK-positive NSCLC\n* Measurable disease per RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Ability and willingness to take oral medication(s)\n* Adequate organ function and bone marrow reserve\n\nExclusion Criteria:\n\n* Prior toxicities from anti-cancer therapy which have not resolved to Grade ≤ 1 per NCI CTCAE v5.0 excluding alopecia, vitiligo, or endocrinopathies manageable with replacement therapy\n* Symptomatic, active CNS metastases or untreated CNS metastases requiring any definitive therapy.\n* Severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or renal disease, or active infection), or with a history or complication of interstitial lung disease\n* Significant cardiovascular disease\n* Inadequately controlled hypertension","ALL","18 Years",{"count":91,"type":92},102,"ESTIMATED","INTERVENTIONAL",[95],"PHASE1","This is a first-in-human, Phase I, 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