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WCLC 2022 | The rationale and trial design of the NADIM II trial

Atocha Romero, PharmD, PhD, Hospital Universitario Puerta de Hierro, discusses the rationale and trial design of the The Phase II NADIM II trial (NCT03838159), which was designed to explore neoadjuvant nivolumab plus chemotherapy versus chemotherapy alone in patients with locally advanced and potentially resectable non-small cell lung cancer (NSCLC). The aim was to validate the results found in the Phase II NADIM trial (NCT03081689) and the Phase III CheckMate 816 trial (NCT02998528). The primary endpoint was pathological complete response (pCR). Data on progression-free survival (PFS) and overall-survival (OS) was presented at WCLC 2022. Madrid, Spain. This interview took place at the IASLC 2022 World Conference on Lung Cancer congress in Vienna, Austria.

Transcript (edited for clarity)

So the NADIM II trial is a Phase II trial in which patients are randomized to receive either nivolumab plus chemotherapy or chemotherapy alone. And the aim is to demonstrate or validate our results that were found in NADIM trial, the previous trial and CheckMate 816 trial. So the primary endpoint was pathological complete response and here, Professor Mariano Provencio will be presenting data on PFS and overall survival...

So the NADIM II trial is a Phase II trial in which patients are randomized to receive either nivolumab plus chemotherapy or chemotherapy alone. And the aim is to demonstrate or validate our results that were found in NADIM trial, the previous trial and CheckMate 816 trial. So the primary endpoint was pathological complete response and here, Professor Mariano Provencio will be presenting data on PFS and overall survival.

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