RecruitingPhase 1/2

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

United States, France, South Korea231 participantsStarted 2020-01-07

Plain-language 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. 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of patients with Dose Limiting Toxicities (DLTs)

Timeframe: Up to 21 days

Incidence and severity of treatment-emergent adverse events (TEAEs)

Timeframe: Through study completion, an average of 12 years

Incidence and severity of adverse events of special interest (AESIs)

Timeframe: Through study completion, an average of 12 years

Incidence and severity of serious adverse events (SAEs)

Timeframe: Through study completion, an average of 12 years

Incidence and severity of grade ≥3 laboratory abnormalities

Timeframe: Through study completion, an average of 12 years

REGN5093 concentrations in serum over time

Timeframe: Through study completion, an average of 12 years

Objective response rate (ORR) per RECIST 1.1

Timeframe: Through study completion, an average of 12 years

Trial details

NCT IDNCT04077099

SponsorRegeneron Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2032-04-22

Contact for this trial

Clinical Trials Administrator

844-734-6643 clinicaltrials@regeneron.com

View on ClinicalTrials.gov More NSCLC trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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

What they're measuring

Number of patients with Dose Limiting Toxicities (DLTs)

Timeframe: Up to 21 days

Incidence and severity of treatment-emergent adverse events (TEAEs)

Timeframe: Through study completion, an average of 12 years

Incidence and severity of adverse events of special interest (AESIs)

Timeframe: Through study completion, an average of 12 years

Incidence and severity of serious adverse events (SAEs)

Timeframe: Through study completion, an average of 12 years

Incidence and severity of grade ≥3 laboratory abnormalities

Timeframe: Through study completion, an average of 12 years

REGN5093 concentrations in serum over time

Timeframe: Through study completion, an average of 12 years

Objective response rate (ORR) per RECIST 1.1

Timeframe: Through study completion, an average of 12 years