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

July 17, 2023 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

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 Contact

  • Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Contact Backup

  • Name: First line of the email MUST contain the NCT# and Site #.

Study Locations

  • Australia
    • New South Wales
      • Liverpool, New South Wales, Australia, 1871
        • Not yet recruiting
        • Local Institution - 0032
        • Contact:
          • Site 0032
      • Wollongong, New South Wales, Australia, 2500
        • Recruiting
        • Local Institution - 0040
        • Contact:
          • Site 0040
    • Victoria
      • Ballarat Central, Victoria, Australia, 3350
        • Recruiting
        • Local Institution - 0012
        • Contact:
          • Site 0012
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Recruiting
        • Local Institution - 0022
        • Contact:
          • Site 0022
  • Belgium
    • BL
      • Roeselare, BL, Belgium, 8800
        • Not yet recruiting
        • Local Institution - 0036
        • Contact:
          • Site 0036
    • WHT
      • Charleroi, WHT, Belgium, 6000
        • Withdrawn
        • Local Institution - 0024
  • Chile
      • Independencia, Chile, 8380456
        • Not yet recruiting
        • Local Institution - 0030
        • Contact:
          • Site 0030
      • Recoleta, Chile, 8420383
        • Not yet recruiting
        • Local Institution - 0027
        • Contact:
          • Site 0027
      • Santiago, Chile, 7500921
        • Recruiting
        • Local Institution - 0023
        • Contact:
          • Site 0023
    • SA
      • Providencia, SA, Chile, 7500653
        • Recruiting
        • Local Institution - 0028
        • Contact:
          • Site 0028
  • France
      • Paris, France, 75005
        • Withdrawn
        • Local Institution - 0037
      • Rouen Cedex, France, 76000
        • Not yet recruiting
        • Local Institution - 0017
        • Contact:
          • Site 0017
      • Saint Herblain, France, 44805
        • Withdrawn
        • Local Institution - 0029
      • Suresnes, France, 92151
        • Not yet recruiting
        • Local Institution - 0015
        • Contact:
          • Site 0015
      • Villejuif, France, 94805
        • Not yet recruiting
        • Local Institution - 0038
        • Contact:
          • Site 0038
  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Local Institution - 0021
        • Contact:
          • Site 0021
      • Barcelone, Spain, 08035
        • Recruiting
        • Local Institution - 0025
        • Contact:
          • Site 0025
      • Madrid, Spain, 28222
        • Recruiting
        • Local Institution - 0019
        • Contact:
          • Site 0019
      • Madrid, Spain, 28041
        • Recruiting
        • Local Institution - 0018
        • Contact:
          • Site 0018
      • Santiago de Compostela, Spain, 15706
        • Not yet recruiting
        • Local Institution - 0026
        • Contact:
          • Site 0026
      • Seville, Spain, 41013
        • Recruiting
        • Local Institution - 0031
        • Contact:
          • Site 0031
    • Málaga
      • Malaga, Málaga, Spain, 29010
        • Recruiting
        • Local Institution - 0020
        • Contact:
          • Site 0020
  • United States
    • Colorado
      • Lone Tree, Colorado, United States, 80124
        • Recruiting
        • Rocky Mountain Cancer Centers - Lone Tree
        • Contact:
          • Robert Jotte, Site 0035
          • Phone Number: 303-388-4876
    • Florida
      • Clermont, Florida, United States, 34711-6699
        • Recruiting
        • Clermont Oncology Center
        • Contact:
          • Gopal Kunta, Site 0043
          • Phone Number: 352-242-1366
      • Orange City, Florida, United States, 32763-8316
        • Recruiting
        • Mid Florida Cancer Center - Orange City
        • Contact:
          • Santosh Nair, Site 0010
          • Phone Number: 13864073531915
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Recruiting
        • Northwest Georgia Oncology Centers, P.C.
        • Contact:
          • Steven McCune, Site 0001
          • Phone Number: 770-281-5162
    • Kentucky
      • Louisville, Kentucky, United States, 40241-2832
        • Recruiting
        • Norton Brownsboro Hospital
        • Contact:
          • Adam Lye, Site 0005
          • Phone Number: 859-323-3000
    • Maryland
      • Silver Spring, Maryland, United States, 20904-7917
        • Recruiting
        • Maryland Oncology Hematology - Silver Spring - White Oak Cancer Center
        • Contact:
          • Vinni Juneja, Site 0044
    • Michigan
      • Detroit, Michigan, United States, 48202-2608
        • Not yet recruiting
        • Henry Ford Hospital
        • Contact:
          • Shirish Gadgeel, Site 0004
          • Phone Number: 313-399-0508
    • Minnesota
      • Rochester, Minnesota, United States, 55902
        • Withdrawn
        • Mayo Clinic Rochester
    • Texas
      • Arlington, Texas, United States, 76012-2510
        • Not yet recruiting
        • Texas Oncology - Arlington North
        • Contact:
          • John Adams, Site 0034
          • Phone Number: 817-261-4906
      • Flower Mound, Texas, United States, 75028
        • Not yet recruiting
        • Texas Oncology - Flower Mound
        • Contact:
          • Enrique Perez, Site 0045
          • Phone Number: 210-227-6156
    • Virginia
      • Fairfax, Virginia, United States, 22031-4629
        • Recruiting
        • Virginia Cancer Specialists - Fairfax
        • Contact:
          • Alexander Spira, Site 0033
          • Phone Number: 703-280-5390

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
Time Frame
Incidence of treatment-related adverse events (TRAEs) leading to study treatment discontinuation
Time Frame: Up to 2 years
Up to 2 years
Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 per investigator assessment
Time Frame: Up to 2 years
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events (AEs)
Time Frame: Up to 2 years
Up to 2 years
Number of participants with serious adverse events (SAEs)
Time Frame: Up to 2 years
Up to 2 years
Number of deaths
Time Frame: Up to 2 years
Up to 2 years
Number of participants with treatment related AEs and SAEs
Time Frame: Up to 2 years
Up to 2 years
Number of participants with AEs of special interest (AESI)
Time Frame: Up to 2 years
Up to 2 years
Number of participants with clinical laboratory abnormalities
Time Frame: Up to 2 years
Up to 2 years
Progression-free Survival (PFS) by RECIST 1.1 per investigator assessment
Time Frame: Up to 2 years
Up to 2 years
Disease Control Rate (DCR) by RECIST 1.1 per investigator assessment
Time Frame: Up to 2 years
Up to 2 years
Duration of Response (DoR) by RECIST 1.1 per investigator assessment
Time Frame: Up to 2 years
Up to 2 years

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 (Estimated)

March 4, 2024

Study Completion (Estimated)

February 28, 2026

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 (Actual)

July 18, 2023

Last Update Submitted That Met QC Criteria

July 17, 2023

Last Verified

July 1, 2023

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.

Clinical Trials on Carcinoma, Non-Small-Cell Lung

Clinical Trials on MORAb-202

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe