Abstract 2014TiP
Background
Immune checkpoint inhibitors (ICIs) are now widely used in monotherapy or in combination with chemotherapy in advanced non-small cell lung cancer (NSCLC), and in combination with chemotherapy in advanced small-cell lung cancer (SCLC). However, few data are currently available concerning the acquired resistance mechanisms to ICIs in lung cancer. There is therefore a need for systematic prospective collection of tumor samples for histological and molecular analyses at the time of progression.
Trial design
REBIMMUNE trial is a prospective, bicentric trial (2 academic centers), that includes consecutive patients with advanced NSCLC or SCLC treated with ICIs (alone or in combination with chemotherapy) experiencing tumor progression while on ICIs. After signature of a consent form, the patients have a new tumor biopsy on a progressive tumor site. On these samples, we will perform various immunohistochemistry tests, including PTEN, Beta-2-microglobuline (B2M), Beta-catenin (Wnt pathway activation), CD8 and PD-L1 expressions. We will also perform targeted molecular screening on PTEN, JAK and B2M genes along with NGS panels. We will compare these results with those performed on corresponding diagnosis samples, and correlate them with clinical outcomes (response rate, progression-free survival, overall survival). We plan to include 100 patients in 2 years.
Clinical trial identification
NCT04300062.
Editorial acknowledgement
Legal entity responsible for the study
Assistance Publique - Hopitaux de Paris (APHP).
Funding
Has not received any funding.
Disclosure
E. Giroux-Leprieur: Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Bristol-Myers-Squibb; Travel/Accommodation/Expenses: MSD; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche. All other authors have declared no conflicts of interest.