Phase Ib/II Study of M3814 With Etoposide and Cisplatin in Small Cell Lung Cancer (SCLC) Extensive Disease (ED)

Study summary

M3814 is an investigational drug under evaluation for treatment of lung cancer. The purpose of the study was to assess the Safety and Efficacy of M3814 in combination with chemotherapy with SCLC ED.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedM3814 and Cisplatin

Plus 1 other study approaches.

Who it may be forSmall cell lung cancer (SCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 16, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?80 U.S. locations

Locations may change over time.

Who runs it?EMD Serono Research & Development Institute, Inc.

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: EMD Serono Research & Development Institute, Inc.
Interventions being studied: Drug: M3814; Drug: Cisplatin; Drug: Etoposide

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Small cell lung cancer (SCLC)→

Treatment approach

Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

To be eligible for the study (Phase Ib and Phase II) the participant must fulfill all of the following criteria:
Male or female participants at least 18 years of age
Histological or cytological diagnosis of SCLC
Extensive disease (ie, disease beyond ipsilateral hemithorax, which may include malignant pleural or pericardial effusion or hematogenous metastases \[Tany, Nany, M1a/b; T3-T4, Nany, M0, due to multiple lung nodules or extent of disease that precludes a tolerable radiation field, as judged by the Investigator\])
Participants eligible for first line platinum-based chemotherapy
Measurable or evaluable disease according to RECIST v1.1
Eastern Cooperative Oncology Group performance status (ECOG PS) less than equals to (\<=) 2
Life expectancy of greater than equals to (≥) 3 months
Female participants of childbearing potential and male participants with female partners of childbearing potential must be willing to avoid pregnancy Note: Other protocol defined criteria could apply.

Reasons someone may not be able to joinExclusion criteria

Participants are not eligible for the study if they fulfill any of the following

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Research siteMesa, Arizona
Research site 1Santa Rosa, California
Research siteSanta Rosa, California
Research siteWhittier, California
Research siteDanbury, Connecticut
Research siteNorwalk, Connecticut
Research siteColumbus, Georgia
Research siteNewnan, Georgia
Research siteTopeka, Kansas
Research siteAshland, Kentucky
Research siteBillings, Montana
Research sitePinehurst, North Carolina

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 16, 2020. Always confirm current availability with the study team.

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