Can chemotherapy be administered during the observation period?

Published

In Phase 3 clinical trials SPOTLIGHT and GLOW, mFOLFOX6 and CAPOX could be given during the post-infusion observation period

In the Phase 3 clinical trials, patients were observed for two hours post zolbetuximab/placebo infusion following the first dose of zolbetuximab/placebo on Cycle 1 Day 1.1,2

  • In Phase 3 clinical trials, the observation period for subsequent infusions was adjusted based on Grade ≥ 2 adverse events during Cycle 1 Day 1.1,2 
  • More information on adjustments to the observation period in Phase 3 clinical trials can be accessed using the link below:

  1. Shitara K, Lordick F, Bang YJ, et al. Supplement to: Zolbetuximab plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, untreated, locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma (SPOTLIGHT): a multicentre, randomised, double-blind, phase 3 trial. Lancet. 2023; 401.(10389):1655-1668. Available at: https://doi.org/10.1016/s0140-6736(23)00620-7.

  2. Shah MA, Shitara K, Ajani JA, et al. Supplement to: Zolbetuximab plus CAPOX in CLDN18.2- positive gastric or gastroesophageal junction adenocarcinoma: the randomized, phase 3 GLOW trial. Nat. Med. 2023; 29.(8):2133-2141. Available at: https://doi.org/10.1038/s41591-023-02465-7.

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