English to Polish Medical Medical: Pharmaceuticals general

Z protokołu badań klinicznych:

If pre-determined criteria for safety and myelopreservation activity are met and the DRC identifies an RP2D of [X], the DRC will make a recommendation regarding initiation of the Phase 1b expansion (SCLC), the NSCLC cohort, and/or the Phase 2 portion of the study (described below). Based on the DRC recommendation, the Sponsor will determine which of these cohorts to open first. Following the DRC recommendation, the Sponsor will open the expansion cohorts (SCLC and NSCLC) at study sites approved and able to enroll into these cohorts. It is possible that not all study sites will participate in the Phase 1b dose expansion in SCLC or the NSCLC portion of study.

In the randomized Phase 1b expansion stage (for participating sites), 20 patients with ED SCLC harboring p53 loss of function mutations requiring 2nd line treatment with [Y] will be randomized in a 1:1 ratio to receive one of two treatment sequences during Cycles 1 and 2 [...].

DRC - Data Review Committee