SummaryThis study will consist of two parts. Part 1 is a dose-escalation study design allowing the assessment of safety, tolerability and recommended dose levels of the combination of trastuzumab deruxtecan (T-DXd) and durvalumab plus cisplatin, carboplatin or pemetrexed. Part 1 will involve people on their second or third-line of treatment. In Part 2, expansions in the treatment naÃ¯ve setting on any recommended dose level may take place to study preliminary efficacy as well. In Part 1, the dose of T-DXd and the chemotherapeutic components on Arms 1A, 1B and 1C (cisplatin, carboplatin or pemetrexed) will be modified during the dose-escalation part in order to find the recommended phase 2 dose (RP2D). The dose of durvalumab will remain fixed in this part of the study. Arm 1D will ass T-DXd as monotherapy. All treatments will be administered via an intravenous (IV) infusion. The Part 2 of the study may be initiated following Part 1, at the discretion of the sponsor.
This trial is treating patients with non-small cell lung cancer.
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A Phase Ib Multicenter, Open-label Dose-escalation Study to Evaluate the Safety and Tolerability of Trastuzumab Deruxtecan (T-DXd) and Durvalumab in Combination With Cisplatin, Carboplatin or Pemetrexed in First-line Treatment of Patients With Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) and Human Epidermal Growth Factor Receptor 2 Overexpression (HER2+) (DESTINY-Lung03)