A Phase 1b, Multicenter, 2-Part, Open-Label Study of Datopotamab Deruxtecan (Dato-DXd) in Combination with Immunotherapy with or without Carboplatin in Participants with Advanced or Metastatic Non-Small Cell Lung Cancer (Tropion-Lung04) - D926FC00001

Astrazeneca AB0 个研究点目标入组 232 人开始时间: 2024年5月15日最近更新: 2024年8月21日

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•Participant =18 years old on the day of signing the ICF (local regulatory requirement to consent should be followed), Histologically or cytologically confirmed diagnosis of advanced or metastatic NSCLC, without EGFR or ALK genomic alterations (not required for squamous histology) and no known genomic alterations in other actionable driver kinases with approved therapies (KRAS mutations eligible), For Cohorts 1 to 4, participants must be treatment-naïve or have received and radiologically progressed after only 1 prior line of systemic chemotherapy, without concomitant immune checkpoint inhibitors for advanced or metastatic NSCLC. For Cohorts 5 to 11, participants must be treatment-naïve for advanced or metastatic NSCLC. For Cohorts 12 & 13, participants must be CPI-acquired resistant after 1 or 2 prior lines of systemic therapy for advanced or metastatic NSCLC, of which 1 prior line of therapy should contain an approved anti-PD-1/PD-L1, Willing and able to undergo a mandatory tumor biopsy, Has measurable disease per RECIST1.1 within 28 days prior to Cycle 1 Day 1, Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1 at screening, Has adequate bone marrow reserve and organ function at baseline within 7 days prior to Cycle 1 day 1, For Cohorts 5 to 14 only: Documented IHC PD-L1 expression per analytically validated Ventana PD-L1 (SP263) IHC assay, 22C3 PharmDx assay, or 28-8 PharmDx assay

•Active or prior documented autoimmune or inflammatory disorders, Uncontrolled or significant cardiac disease, History of another primary malignancy with exceptions, active or uncontrolled hepatitis B or C virus or uncontrolled HIV infection, spinal cord compression or clinically active CNS metastases, History of (non-infectious) ILD/pneumonitis, including radiation pneumonitis, that required steroids, Clinically severe pulmonary compromise resulting from intercurrent pulmonary illness, Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals, Clinically significant corneal disease

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