A Study of MORAb-202 in Participants With Previously Treated Metastatic Non-Small Cell Lung Cancer (NSCLC) Adenocarcinoma (AC)

NCT ID: NCT05577715

Last Updated: 2025-09-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-14

Study Completion Date

2024-08-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study is to characterize the safety and tolerability of MORAb-202, and to assess the objective response rate in participants with previously treated, metastatic NSCLC AC.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Carcinoma, Non-Small-Cell Lung

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MORAb-202

Group Type EXPERIMENTAL

MORAb-202

Intervention Type DRUG

Specified dose on specified days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MORAb-202

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Farletuzumab Ecteribulin BMS-986445

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Histologically or cytologically documented metastatic NSCLC AC (as defined by the 8th International Association for the Study of Lung Cancer Classification).
* Measurable target disease assessed by the investigator according to RECIST 1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1

Exclusion Criteria

* NSCLC histologies other than AC (ie, squamous cell carcinoma, large cell carcinoma).
* Significant third-space fluid retention (eg, ascites or pleural effusion) that requires repeated drainage.
* Prior pneumonectomy. Prior lobectomy and segmentectomy are allowed \> 12 months before treatment.
* Recent chest radiotherapy. Participants with chest or chest wall radiation may be permitted if chest radiation is documented \> 6 months before starting study treatment.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Eisai Inc.

INDUSTRY

Sponsor Role collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Local Institution - 0007

Orange, California, United States

Site Status

Local Institution - 0035

Lone Tree, Colorado, United States

Site Status

Local Institution - 0043

Clermont, Florida, United States

Site Status

Local Institution - 0010

Orange City, Florida, United States

Site Status

Local Institution - 0001

Marietta, Georgia, United States

Site Status

Local Institution - 0005

Louisville, Kentucky, United States

Site Status

Local Institution - 0044

Silver Spring, Maryland, United States

Site Status

Henry Ford Hospital

Detroit, Michigan, United States

Site Status

Local Institution - 0002

Kansas City, Missouri, United States

Site Status

Local Institution - 0011

Charlotte, North Carolina, United States

Site Status

Local Institution - 0034

Arlington, Texas, United States

Site Status

Local Institution - 0045

Flower Mound, Texas, United States

Site Status

Local Institution - 0033

Fairfax, Virginia, United States

Site Status

Local Institution - 0040

Wollongong, NS, Australia

Site Status

Local Institution - 0012

Ballarat Central, Victoria, Australia

Site Status

Local Institution - 0022

Murdoch, Western Australia, Australia

Site Status

Local Institution - 0039

Mons, WHT, Belgium

Site Status

Local Institution - 0036

Roeselare, , Belgium

Site Status

Local Institution - 0028

Providencia, SA, Chile

Site Status

Local Institution - 0030

Independencia, , Chile

Site Status

Local Institution - 0027

Recoleta, , Chile

Site Status

Local Institution - 0023

Santiago, , Chile

Site Status

Local Institution - 0017

Rouen, , France

Site Status

Local Institution - 0015

Suresnes, , France

Site Status

Local Institution - 0014

Toulon, , France

Site Status

Local Institution - 0038

Villejuif, , France

Site Status

Local Institution - 0020

Málaga, MA, Spain

Site Status

Local Institution - 0019

Majadahonda (Madrid), M, Spain

Site Status

Local Institution - 0025

Barcelona, , Spain

Site Status

Local Institution - 0021

Barcelona, , Spain

Site Status

Local Institution - 0018

Madrid, , Spain

Site Status

Local Institution - 0026

Santiago de Compostela, , Spain

Site Status

Local Institution - 0031

Seville, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Australia Belgium Chile France Spain

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2022-000131-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MORAb-202-G000-203

Identifier Type: OTHER

Identifier Source: secondary_id

CA116-003

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Taletrectinib Phase 2 Global Study in ROS1 Positive NSCLC
NCT04919811 ACTIVE_NOT_RECRUITING PHASE2