REGN5093 in Patients with MET-Altered Advanced Non-Small Cell Lung Cancer

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 111

Inclusion Criteria

1: Histologically confirmed NSCLC that is at advanced stage. Advanced is defined as unresectable or metastatic disease. Patients must have exhausted all approved available therapies appropriate for the patient.
2: Has available archival tumor tissue, unless discussed with the medical monitor.
3: Willing to provide tumor tissue from newly obtained biopsy. Newly obtained biopsies at screening are required unless medically contra-indicated and discussed with the medical monitor. For patients in expansion cohorts, biopsies should be taken from tumor site which has not been irradiated previously and is not the only measurable target lesion.
4: Previously documented presence of MET alterations: either MET-exon14 gene mutation and/or MET gene amplification, and/or elevated MET protein expression, as defined in the protocol

Other protocol-defined Inclusion criteria apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1: Has not yet recovered (i.e. grade =1 or baseline) from any acute toxicities resulting from prior therapy except for:
- laboratory changes as described in the protocol, and
- patients with grade =2 neuropathy
For immune-related AEs (irAEs) affecting any organ system within 2 months prior to enrollment there must be documentation of a trajectory of improvement of this irAE (to grade =1 or baseline by the time of enrollment) AND for those toxicities that remain at grade 1, documentation of 2 stable evaluations separated by at least 4 weeks
2: Has received radiation therapy or major surgery within 14 days of first administration of study drug or has not recovered (i.e. grade =1 or baseline) from AEs, except for laboratory changes as described in the protocol and patients with grade =2 neuropathy
3: For expansion cohorts only: prior treatment with MET-targeted biologic therapy (function-blocking antibodies or ADCs) and with any MET-targeted agent including small molecule tyrosine kinase inhibitors eg, crizotinib, capmatinib, tepotinib, as defined in the protocol
4: Untreated or active primary brain tumor, CNS metastases, leptomeningeal disease or spinal cord compression as defined in the protocol

Other protocol-defined Exclusion criteria apply.