The Efficacy and Safety of Osimertinib with Platinum plus Pemetrexed Chemotherapy as First-line Treatment in Advanced Non-small Cell Lung Cancer Patients with Uncommon Epidermal Growth Factor Receptor Mutations: A phase2, Open Label, Single Arm, Multicenter, Exploratory Study
18 Years +
Endpoint Classification: -
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Verified 01 Nov 2022 by AstraZeneca
This is an open-label, single-arm, multicenter, exploratory Phase II study sponsored by Astrazeneca Investment (China) Co., LTD. to evaluate the efficacy and safety of Osimertinib with Platinum plus Pemetrexed Chemotherapy, as First-line Treatment in Recurrent or Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Patients with Uncommon Epidermal Growth Factor Receptor Mutations (EGFRm).
Participants successfully enrolled into the study will receive 80mg osimertinib QD p.o. plus standard chemotherapy composed of cisplatin or carboplatin and pemetrexed i.v. on Day 1 of a 21 day cycle (every 3 weeks) for 4 to 6 cycles, followed by osimertinib 80 mg QD p.o. plus pemetrexed maintenance i.v. every 3 weeks until RECIST 1.1-defined radiological progression as judged by the investigator. Tumour assessments will be performed as per RECISTv1.1 criteria, using computed tomography (CT)/magnetic resonance imaging (MRI). The baseline assessment is part of the screening procedures and should be performed before the start of study intervention. safety will be assessed in the whole treatment period as well as 28 days after study drug termination for any reason.
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|Experimental: Osimertinib plus standard chemotherapy|