TeliMET NSCLC-01 (NCT04928846) is a global, multicenter, randomized, open-label Phase III trial comparing the antibody–drug conjugate Telisotuzumab Vedotin (ABBV-399) versus Docetaxel in adults with previously treated, locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) that overexpresses c-Met and is EGFR wild-type. The co-primary endpoints are overall survival (OS) and progression-free survival (PFS) assessed by blinded independent central review. Eligible subjects must have histologically or cytologically confirmed non-squamous NSCLC, c-Met overexpression (= 25 % tumor cells at 3+ intensity by IHC, SP44 assay), EGFR wild-type status, ECOG performance status = 1, and prior systemic therapy. Participants are randomized 1:1 to receive either Telisotuzumab Vedotin intravenously every 2 weeks or Docetaxel every 3 weeks. Key secondary endpoints include objective response rate (ORR), duration of response, health-related quality of life, and safety/tolerability.
The TeliMET NSCLC-01 study tests a new drug, Telisotuzumab Vedotin, in adults with advanced or metastatic non-squamous non-small cell lung cancer whose tumors overexpress c-Met and are EGFR wild-type. Participants are randomly assigned to receive either Telisotuzumab Vedotin via intravenous infusion or the standard chemotherapy drug Docetaxel. The aim is to find out whether Telisotuzumab Vedotin is more effective and tolerable than Docetaxel. Eligible are adults whose disease has already been treated and who have c-Met overexpression. The trial assesses both tumor response (disease control) and safety of the treatments.
