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

September 1, 2025 updated by: Bristol-Myers Squibb

A Phase 2, Open-label, Randomized Study of MORAb-202 (Farletuzumab Ecteribulin), a Folate Receptor Alpha-targeting Antibody-Drug Conjugate, in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) Adenocarcinoma (AC) After Progression on Prior Therapies

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • NS
      • Wollongong, NS, Australia, 2500
        • Local Institution - 0040
    • Victoria
      • Ballarat Central, Victoria, Australia, 3350
        • Local Institution - 0012
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Local Institution - 0022
  • Belgium
      • Roeselare, Belgium, 8800
        • Local Institution - 0036
    • WHT
      • Mons, WHT, Belgium, 7000
        • Local Institution - 0039
  • Chile
      • Independencia, Chile, 8380456
        • Local Institution - 0030
      • Recoleta, Chile, 8420383
        • Local Institution - 0027
      • Santiago, Chile, 7500921
        • Local Institution - 0023
    • SA
      • Providencia, SA, Chile, 7500653
        • Local Institution - 0028
  • France
      • Rouen, France, 76000
        • Local Institution - 0017
      • Suresnes, France, 92151
        • Local Institution - 0015
      • Toulon, France, 83056
        • Local Institution - 0014
      • Villejuif, France, 94805
        • Local Institution - 0038
  • Spain
      • Barcelona, Spain, 08036
        • Local Institution - 0021
      • Barcelona, Spain, 08035
        • Local Institution - 0025
      • Madrid, Spain, 28041
        • Local Institution - 0018
      • Santiago de Compostela, Spain, 15706
        • Local Institution - 0026
      • Seville, Spain, 41013
        • Local Institution - 0031
    • M
      • Majadahonda (Madrid), M, Spain, 28222
        • Local Institution - 0019
    • MA
      • Málaga, MA, Spain, 29010
        • Local Institution - 0020
  • United States
    • California
      • Orange, California, United States, 92868-3201
        • Local Institution - 0007
    • Colorado
      • Lone Tree, Colorado, United States, 80124
        • Local Institution - 0035
    • Florida
      • Clermont, Florida, United States, 34711-6699
        • Local Institution - 0043
      • Orange City, Florida, United States, 32763-8316
        • Local Institution - 0010
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Local Institution - 0001
    • Kentucky
      • Louisville, Kentucky, United States, 40241-2832
        • Local Institution - 0005
    • Maryland
      • Silver Spring, Maryland, United States, 20904-7917
        • Local Institution - 0044
    • Michigan
      • Detroit, Michigan, United States, 48202-2608
        • Henry Ford Hospital
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Local Institution - 0002
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Local Institution - 0011
    • Texas
      • Arlington, Texas, United States, 76012-2510
        • Local Institution - 0034
      • Flower Mound, Texas, United States, 75028-1713
        • Local Institution - 0045
    • Virginia
      • Fairfax, Virginia, United States, 22031-4629
        • Local Institution - 0033

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Other protocol-defined inclusion/exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MORAb-202
Drug: MORAb-202
Specified dose on specified days
Other Names:
  • BMS-986445
  • Farletuzumab Ecteribulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate as Per Investigator
Time Frame: From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (Up to approximately 12 months)

ORR is defined as the percentage of participants whose best overall response (BOR) is either CR or PR per response evaluation criteria in solid tumors (RECIST) v1.1 based on Clopper-Pearson method.

Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (Up to approximately 12 months)
Number of Participants With Drug -Related Adverse Events Leading to Discontinuation
Time Frame: From first dose and 30 days after last dose of study therapy (up to approximately 12 months).
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
From first dose and 30 days after last dose of study therapy (up to approximately 12 months).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events and Serious Adverse Events and Adverse Event of Special Interest (AESI) and Deaths and Grade 3/4 Laboratory Abnormalities (SI Units)
Time Frame: From first dose and 30 days after last dose of study therapy (up to approximately 12 months).
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Serious adverse events (SAE) are defined as any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Death).
From first dose and 30 days after last dose of study therapy (up to approximately 12 months).
Disease Control Rate as Per Investigator
Time Frame: From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (Up to approximately 12 months)

Disease Control Rate (DCR) is defined as the number of randomized participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD) divided by the number of all randomized participants. per response evaluation criteria in solid tumors (RECIST) v1.1 based on Clopper-Pearson method.

Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.

Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (Up to approximately 12 months)
Duration of Response as Per Investigator
Time Frame: From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (Up to approximately 12 months)

DOR for a participant with a best overall response (BOR) of CR or PR is defined as the time between the date of first response and the date of the first objectively documented tumor progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death, whichever occurs first.

CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.

PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (Up to approximately 12 months)
Progression Free-Survival as Per Investigator
Time Frame: From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (Up to approximately 12 months)

PFS is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression or death due to any cause, whichever is earlier.

Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (Up to approximately 12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Collaborators

Eisai Inc.

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2022

Primary Completion (Actual)

August 12, 2024

Study Completion (Actual)

August 12, 2024

Study Registration Dates

First Submitted

October 10, 2022

First Submitted That Met QC Criteria

October 10, 2022

First Posted (Actual)

October 13, 2022

Study Record Updates

Last Update Posted (Estimated)

September 4, 2025

Last Update Submitted That Met QC Criteria

September 1, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA116-003
  • 2022-000131-23 (EudraCT Number)
  • MORAb-202-G000-203 (Other Identifier: Eisai Protocol Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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