Recurrent/Advanced Gastric Cancer Clinical Trial
Official title:
An Open Label, Single-Arm, Multi-Center Phase II Study to Evaluate the Efficacy of Triplet Combination With Pembrolizumab, Neratinib, and Paclitaxel as a Second Line Treatment in Recurrent/Advanced Gastric Cancer Having Somatic Human Epidermal Growth Factor Receptor Family (EGFR, HER2, HER3, HER4) Mutations or HER2 Amplification/Overexpression
Clinical Indication : HER mutated or HER2 Amplification/Overexpression in Gastric Cancer, 2nd-line Trial Type : Interventional, Open label Treatment Groups : Single arm: Pembrolizumab 200 mg every 3 weeks (Q3W), neratinib at 240 mg once daily (QD), and paclitaxel 175 mg/m2 every 3 weeks (Q3W) Number of trial participants : Approximately 68 patients will be enrolled (with 10% drop-out). Estimated enrollment period : 24 months Estimated duration of trial : It is estimated that the trial will require approximately 30 months from the time the first patient signs the informed consent until the last patient's last visit. - First Patient In: Mar 2021 - Last Patient In: Feb 2023 - Last Patient Last Visit: Aug 2023 Duration of Participation : 30 months
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