A Study of Amivantamab (JNJ-61186372) Among Participants With Advanced NSCLC Harboring ALK, ROS1, and RET Gene Fusions in Combination With Tyrosine Kinase Inhibitors (TKIs)

Inclusion criteria: Participant has locally advanced (unresectable) or metastatic NSCLC with a known RET fusion. Participants must have clinical progression on at least one prior RET therapy. They must be on a RET inhibitor at the same dose for at least 3 months prior to enrolling on this study. RET inhibitors that will be considered include but not limited to selpercatinib and pralsetinib. The patient cannot have received an EGFR TKI (e.g. osimertinib, afatinib), EGFR-directed monoclonal antibody (e.g. cetuximab), MET-inhibitor (e.g., tepotinib, capmatinib, telisotuzumab vedotin, etc.) at any point prior to study entry.

Sponsor/Collaborator: University of Colorado, Denver and Janssen Research & Development, LLC

Contact and Locations:
Study contact: Principal Investigator: Tejas Patil Febin Elias
Phone: 303-724-9459
Email: febin.elias@cuanschutz.edu
Locations: Colorado Research Center, Colorado Outpatient CTRC, UCHealth Metro Denver, University of Michigan Rogel Cancer Center

Mechanism of action: In many of these cases, increased activation of the (epidermal growth factor receptor (ERBB) or mesenchymal-epithelial transition (cMet) pathways appears to be a bypass signaling mechanism that allows cancer cells to circumvent the selective pressure from RET TKIs. Amivantamab is a bispecific antibody that binds to the extracellular domains of EGFR and MET.

Phases: Phase 1, Phase 2

NCT Number: NCT05845671

Status: Recruiting

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