Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04077099 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Study of REGN5093 in Adult Patients With Mesenchymal Epithelial Transition Factor (MET)-Altered Advanced Non-Small Cell Lung Cancer

StatusActive, Not Recruiting
PhasePhase 1/2
Started2020-01-07
View on ClinicalTrials.gov ↗

Amendment history

2026-09-17
Enrollment closed, study ongoing
Final enrollment: 95 participants (planned 231)
Trial sites reduced: 40 → 29 locations
Primary completion moved earlier: 2032-04-22 → 2027-07-06
Completion moved earlier: 2032-04-22 → 2027-07-06
2026-06-16
Study Status, Contacts/Locations v27
Study sites40 entries, revised
Severance Hospital Yonsei University Health System
2026-03-16
Study Status, Contacts/Locations v26
Study sites34→40
2026-03-03
Study Status, Contacts/Locations v25
Study sites33→34
2025-12-16
Study Status, Contacts/Locations v24
Study sites33 entries, revised
Georgetown University HospitalMedical Center
Show 23 earlier versions
2025-12-01
Study Status, Contacts/Locations v23
Study sitesdetails revised at 2 of 33 sites
2025-11-24
Study Status, Contacts/Locations v22
Study sites32→33
2025-11-13
Active, Not Recruiting→Recruiting Study Status, Contacts/Locations v21
Trial statusActive, Not Recruiting→Recruiting
Primary completion date2032-03-09→2032-04-22
Completion date2032-03-09→2032-04-22
Study sites30→32
2025-09-30
Study Identification, Study Status v20
Primary completion date2032-01-01→2032-03-09
Completion date2032-01-01→2032-03-09
2024-09-16
Study Identification, Study Status, Study Description, Study Design, Outcome Measures, Eligibility, IPDSharing v19
Primary completion date2024-10-20→2032-01-01
Completion date2024-10-20→2032-01-01
Enrollment target82→231
Eligibility criteria-963 characters
Key Inclusion Criteria: Histologically confirmed advanced NSCLC that is at advanced stage. Advanced is defined as unresectable or metastatic disease. Patientsas mustdescribed have exhausted all approved available therapies appropriate forin the patient. Has available archival tumor tissue, unless discussed with the medical monitor.protocol Willing to provide tumor tissue fromas newlydescribed obtained biopsy. Newly obtained biopsies at screening are required unless medically contra-indicated and discussed within the medical monitor.protocol For patients in expansion cohorts, biopsies should be [...] [...]
Secondary endpoints12 to 14 entries
ImmunogenicityTime asto measuredresponse by(TTR) Antiper RECIST 1.1 Incidence of anti-drug antibodies (ADA) to REGN5093 Titer of ADA to REGN5093
Primary endpoints7 entries, revised
Incidence and severity of treatment-emergent adverse events (TEAEs) Number of patients with Dose Limiting Toxicities (DLTs)
Study title+60 characters
A Study of REGN5093 in Adult Patients With Mesenchymal Epithelial Transition Factor (MET)-Altered Advanced Non-Small Cell Lung Cancer
2024-03-05
Study Status v18
Re-verified, no change to tracked fields
2023-03-08
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v17
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 111→confirmed 82
Study sitesdetails revised at 30 of 30 sites
2023-02-21
Study Status, Contacts/Locations v16
Study sitesdetails revised at 2 of 30 sites
2022-09-22
Study Status, Contacts/Locations v15
Study sitesdetails revised at 2 of 30 sites
2022-05-24
Study Status, Contacts/Locations v14
Study sitesdetails revised at 2 of 30 sites
2022-04-11
Study Status, Contacts/Locations v13
Study sitesdetails revised at 4 of 30 sites
2022-04-01
Study Status, Contacts/Locations v12
Study sites29→30
2021-10-28
Study Status v11
Primary completion date2023-11-03→2024-10-20
Completion date2023-11-03→2024-10-20
2021-06-15
Study Status, Contacts/Locations v10
Study sites28→29
2021-05-21
Study Status, Contacts/Locations v9
Study sites27→28
2021-04-13
Study Status, Contacts/Locations v8
Study sites26→27
2021-02-19
Study Status, Contacts/Locations v7
Study sites18→26
2021-01-07
Study Status, Study Description, Study Design, Outcome Measures, Eligibility, Contacts/Locations v6
Primary completion date2024-02-15→2023-11-03
Completion date2024-02-15→2023-11-03
Enrollment target102→111
Study sites16→18
Eligibility criteria+510 characters
[...] atients must have exhausted all approved available therapies appropriate for the patient. Has available archival tumor tissue, unless discussed with the medical monitor. 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. Newly obtained biopsies at screening are required unless discussed with the medical [...] [...]
Secondary endpoints12 entries, revised
Incidence and severity of ≥grade ≥3 laboratory abnormalities
Primary endpoints7 entries, revised
Incidence and severity of ≥grade ≥3 laboratory abnormalities
2020-08-13
Study Status, Contacts/Locations v5
Study sites6→16
2020-04-22
Study Status, Contacts/Locations, IPDSharing v4
Study sites4→6
2020-01-23
Study Status, Contacts/Locations v3
Start dateestimated 2020-01-15→confirmed 2020-01-07
Study sites2→4
2019-12-18
Study Status v2
Start date2019-11-27→2020-01-15
2019-11-19
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2024-01-19→2024-02-15
Completion date2024-01-19→2024-02-15
Start date2019-10-15→2019-11-27
Study sites0→2
2019-08-29
Original filing
This study will evaluate REGN5093 for the treatment of Non-Small Cell Lung Cancer (NSCLC) with MET alteration. The main purpose of this study is to determine the safety, tolerability, and effectiveness of REGN5093. The study has two phases. The main goal of Phase 1 is to determine a safe dose(s) of REGN5093. The main goal of phase 2 of the study is to use the REGN5093 drug dose(s) found in Phase 1 to see how well REGN5093 works to shrink tumors. The study is looking at several other research questions, including: * Side effects that may be experienced by people taking REGN5093 * How REGN5093 works in the body * How much REGN5093 is present in the blood * To see if REGN5093 works to reduce or delay the progression of cancer * How long it takes REGN5093 to work in the body
Trial Details
NCT Number NCT04077099
Lead Sponsor Regeneron Pharmaceuticals
Conditions NSCLC
Enrollment 95 participants
Start Date 2020-01-07
Primary Completion 2027-07-06 (estimated)
Study Completion 2027-07-06 (estimated)
Updated on ClinicalTrials.gov 2026-09-16