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)

Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

Safety and tolerability of combination treatment with Dato-DXd and immunotherapy with or without up to 4 cycles of carboplatin, as measured by DLTs, TEAEs, SAEs, AESIs, ECOG PS, vital sign measurements, standard clinical laboratory parameters (hematology, clinical chemistry, and urinalysis), ECG parameters, ECHO/MUGA scan findings, and ophthalmologic findings

Efficacy of combination treatment with Dato-DXd and immunotherapy, with or without up to 4 cycles of carboplatin as measured by ORR, DoR, DCR, PFS, TTR, Best percentage change in the SoD of measurable tumors and OS, PK of Dato-DXd, durvalumab, AZD2936, MEDI5752 and AZD7789, with or without up to 4 cycles of carboplatin as assessed by plasma concentrations and PK parameters of Dato-Dxd, total anti-TROP2 antibody and DXd (MAAA-1181a). Serum concentrations and PK parameters of durvalumab, AZD2936, MEDI5752 and AZD7789, Immunogenicity of Dato-DXd, durvalumab, AZD2936, MEDI5752 and AZD7789 with or without 4 cycles of carboplatin as assessed by the prevalence and incidence of Dato-DXd, durvalumab, AZD2936, MEDI5752 and AZD7789 ADA.

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