NSCLCPhase 1/2NCT04077099
A Study of REGN5093 in Adult Patients With Mesenchymal Epithelial Transition Factor (MET)-Altered Advanced Non-Small Cell Lung Cancer
A Phase 1/2 study testing REGN5093 in people with NSCLC, run by Regeneron Pharmaceuticals at 29 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- REGN5093
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 29 sitesin 3 countries
- Study dates
- 7 Jan 2020to 6 Jul 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed advanced NSCLC that is unresectable or metastatic as described in the protocol
- Willing to provide tumor tissue as described in the protocol
- Documented presence of MET alteration as described in the protocol.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ and bone marrow function as described in the protocol
Who cannot join
- Has received treatment with an approved systemic therapy or has participated in any study of an investigational agent or investigational device within 2 weeks as described in the protocol
- Has not yet recovered from any acute toxicities resulting from prior therapy with certain exceptions as described in the protocol
- Has received radiation therapy or major surgery within 14 days as described in the protocol
- Untreated or active primary brain tumor, central nervous system (CNS) metastases, leptomeningeal disease or spinal cord compression as defined in the protocol
- Uncontrolled infection as described in the protocol
- Note: Other protocol defined Inclusion/Exclusion criteria apply
Trial locations and contacts
29 sites in 3 countries.
29 sites in 3 countries
South Korea16 sites
Pusan National University Hospital
Busan, 49241
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, 28644
National Cancer Center
Gyeonggi-do, Gyeonggi-do, 10408
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, 58128
Gachon University Gil Medical Center
Incheon, Namdong-gu, 21565
Haeundae Paik Hospital
Pusan, Gyeongsangnam-do, 48108
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Severance Hospital Yonsei University Health System
Seoul, 03722
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
Seol St. Mary's Hospital
Seoul, 06591
Boramae Medical Center
Seoul, 07061
Korea University Guro Hospital
Seoul, 08308
Seoul National University Hospital
Seoul, 3080
The Catholic University Of Korea St. Vincent's Hospital
Suwon, Gyeonggi-do, 16247
Ajou University Hospital
Suwon, Gyeonggi-do, 16499
United States8 sites
Dana Farber Harvard Cancer Center Consortium
Boston, Massachusetts, 02215
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of California Irvine Medical Center - Bldg 56, RT81, Rm 241
Orange, California, 92868
University of Pittsburgh UPMC - Clinical Research Services
Pittsburgh, Pennsylvania, 15232
Moffitt Cancer Center - McKinley Drive
Tampa, Florida, 33612
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
France5 sites
Institut Bergonie
Bordeaux, New Aquitaine, 33076
Centre Francois Baclesse (CFB)
Caen, Normandy, 14076
Centre Hospitalier Universitaire de Grenoble
Grenoble, 38043
Centre Hospitalier Regional Universitaire (CHRU) Montpellier Arnaud de Villeneuve
Montpellier, 34295
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
Rennes, Bretange, 35033
About this study
Official title: A Phase 1/2 Study of REGN5093 in Patients With MET-Altered Advanced Non-Small Cell Lung Cancer
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.
Read more
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
- Conditions
- NSCLC
- Being tested
- REGN5093
- Keywords
- MET (mesenchymal-epithelial transition factor), HGF (Hepatocyte Growth Factor), NSCLC (non-small cell lung cancer), MET-altered advanced, Unresectable, Metastatic disease
- Medical subject headings
- Deafness, Autosomal Recessive 39, Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN5093Drug
Also called davutamig
Intravenous (IV) infusion. There will be a series of dose escalation cohorts followed by an expansion phase.
| Study group | Role | What they receive |
|---|---|---|
| REGN5093 | Experimental | Monotherapy in dose escalation cohorts (phase 1) followed by an expansion phase (phase 2) Receives: Drug: REGN5093 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with Dose Limiting Toxicities (DLTs)
Phase 1/Dose escalation
Measured: Up to 21 days
Incidence and severity of treatment-emergent adverse events (TEAEs)
Phase 1/Dose escalation
Measured: Through study completion, an average of 12 years
Incidence and severity of adverse events of special interest (AESIs)
Phase 1/Dose escalation
Measured: Through study completion, an average of 12 years
Incidence and severity of serious adverse events (SAEs)
Phase 1/Dose escalation
Measured: Through study completion, an average of 12 years
Incidence and severity of grade ≥3 laboratory abnormalities
Phase 1/Dose escalation
Measured: Through study completion, an average of 12 years
REGN5093 concentrations in serum over time
Phase 1/Dose escalation
Measured: Through study completion, an average of 12 years
Objective response rate (ORR) per RECIST 1.1
Phase 2/Dose expansion
Measured: Through study completion, an average of 12 years
Secondary outcomes (14)
ORR per RECIST 1.1
Phase 1/Dose escalation
Measured: Through study completion, an average of 12 years
Incidence and severity of TEAEs
Phase 2/Dose expansion
Measured: Through study completion, an average of 12 years
Incidence and severity of AESIs
Phase 2/Dose expansion
Measured: Through study completion, an average of 12 years
Incidence and severity of SAEs
Phase 2/Dose expansion
Measured: Through study completion, an average of 12 years
Incidence and severity of grade ≥3 laboratory abnormalities
Phase 2/Dose expansion
Measured: Through study completion, an average of 12 years
REGN5093 Pharmacokinetics (PK)
Phase 2/Dose expansion
Measured: Through study completion, an average of 12 years
REGN5093 concentrations in serum over time
Phase 2/Dose expansion
Measured: Through study completion, an average of 12 years
Duration of response (DOR) per RECIST 1.1.
Phase 1 and 2
Measured: Through study completion, an average of 12 years
Disease control rate (DCR) per RECIST 1.1.
Phase 1 and 2
Measured: Through study completion, an average of 12 years
Progression free survival (PFS) per RECIST 1.1.
Phase 1 and 2
Measured: Through study completion, an average of 12 years
Overall survival (OS)
Phase 1 and 2
Measured: Through study completion, an average of 12 years
Time to response (TTR) per RECIST 1.1
Phase 1 and 2
Measured: Through study completion, an average of 12 years
Incidence of anti-drug antibodies (ADA) to REGN5093
Phase 1 and 2
Measured: Through study completion, an average of 12 years
Titer of ADA to REGN5093
Phase 1 and 2
Measured: Through study completion, an average of 12 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start7 Jan 2020
- Primary completion6 Jul 2027 (estimated)
- Study completion6 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04077099
- Sponsor's protocol ID
- R5093-ONC-1863
- Other IDs
- 2019-001908-38, 2023-506248-18-00, 2023, 2019
- Status last verified
- Sep 2026
- First submitted
- 13 Aug 2019
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of REGN5093 in Patients With MET-Altered Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04077099
- Acronym / sponsor ID
- R5093-ONC-1863
- Conditions
- NSCLC
- Keywords
- MET (mesenchymal-epithelial transition factor), HGF (Hepatocyte Growth Factor), NSCLC (non-small cell lung cancer), MET-altered advanced, Unresectable, Metastatic disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 6 Jul 2027 (estimated)
- Study completion
- 6 Jul 2027 (estimated)
- First posted
- 4 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| REGN5093 | Experimental | Drug: REGN5093Monotherapy in dose escalation cohorts (phase 1) followed by an expansion phase (phase 2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically confirmed advanced NSCLC that is unresectable or metastatic as described in the protocol
- Willing to provide tumor tissue as described in the protocol
- Documented presence of MET alteration as described in the protocol.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ and bone marrow function as described in the protocol
Key exclusion criteria (6 listed)
- Has received treatment with an approved systemic therapy or has participated in any study of an investigational agent or investigational device within 2 weeks as described in the protocol
- Has not yet recovered from any acute toxicities resulting from prior therapy with certain exceptions as described in the protocol
- Has received radiation therapy or major surgery within 14 days as described in the protocol
- Untreated or active primary brain tumor, central nervous system (CNS) metastases, leptomeningeal disease or spinal cord compression as defined in the protocol
- Uncontrolled infection as described in the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REGN5093Also: davutamigIntravenous (IV) infusion. There will be a series of dose escalation cohorts followed by an expansion phase. | Drug | REGN5093 |
Primary outcome
Number of patients with Dose Limiting Toxicities (DLTs)
Time frame: Up to 21 days
Phase 1/Dose escalation
Incidence and severity of treatment-emergent adverse events (TEAEs)
Time frame: Through study completion, an average of 12 years
Phase 1/Dose escalation
Incidence and severity of adverse events of special interest (AESIs)
Time frame: Through study completion, an average of 12 years
Phase 1/Dose escalation
Incidence and severity of serious adverse events (SAEs)
Time frame: Through study completion, an average of 12 years
Phase 1/Dose escalation
Incidence and severity of grade ≥3 laboratory abnormalities
Time frame: Through study completion, an average of 12 years
Phase 1/Dose escalation
REGN5093 concentrations in serum over time
Time frame: Through study completion, an average of 12 years
Phase 1/Dose escalation
Objective response rate (ORR) per RECIST 1.1
Time frame: Through study completion, an average of 12 years
Phase 2/Dose expansion
14 secondary outcomes
ORR per RECIST 1.1
Time frame: Through study completion, an average of 12 years
Incidence and severity of TEAEs
Time frame: Through study completion, an average of 12 years
Incidence and severity of AESIs
Time frame: Through study completion, an average of 12 years
Incidence and severity of SAEs
Time frame: Through study completion, an average of 12 years
Incidence and severity of grade ≥3 laboratory abnormalities
Time frame: Through study completion, an average of 12 years
REGN5093 Pharmacokinetics (PK)
Time frame: Through study completion, an average of 12 years
REGN5093 concentrations in serum over time
Time frame: Through study completion, an average of 12 years
Duration of response (DOR) per RECIST 1.1.
Time frame: Through study completion, an average of 12 years
Disease control rate (DCR) per RECIST 1.1.
Time frame: Through study completion, an average of 12 years
Progression free survival (PFS) per RECIST 1.1.
Time frame: Through study completion, an average of 12 years
Overall survival (OS)
Time frame: Through study completion, an average of 12 years
Time to response (TTR) per RECIST 1.1
Time frame: Through study completion, an average of 12 years
Incidence of anti-drug antibodies (ADA) to REGN5093
Time frame: Through study completion, an average of 12 years
Titer of ADA to REGN5093
Time frame: Through study completion, an average of 12 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceuticals
29 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing REGN5093 in people with NSCLC, run by Regeneron Pharmaceuticals at 29 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in South Korea, United States, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with Dose Limiting Toxicities (DLTs) (time frame: Up to 21 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.