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

NCT05577715 | Terminated Phase 2 Results FDA Drug

• 3 other identifiers: CA116-0032022-000131-23MORAb-202-G000-203
• Study Type: interventional
• Target: 31
• Locations: 6 countries
• Sites: 33

Brief Summary

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

NSCLC; MORAb-202; Farletuzumab ecteribulin; Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate as Per Investigator

  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

  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 Outcomes (4)

• 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)

  From first dose and 30 days after last dose of study therapy (up to approximately 12 months).

• Disease Control Rate as Per Investigator

  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

  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

  From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (Up to approximately 12 months)

Study Arms (1)

MORAb-202

EXPERIMENTAL

Drug: MORAb-202

Interventions

MORAb-202 DRUG

Specified dose on specified days

Also known as: Farletuzumab Ecteribulin, BMS-986445

MORAb-202

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Eisai Inc.: collaborator

Study Sites (33)

Local Institution - 0007

Orange, California, 92868-3201, United States

Location

Local Institution - 0035

Lone Tree, Colorado, 80124, United States

Location

Local Institution - 0043

Clermont, Florida, 34711-6699, United States

Location

Local Institution - 0010

Orange City, Florida, 32763-8316, United States

Location

Local Institution - 0001

Marietta, Georgia, 30060, United States

Location

Local Institution - 0005

Louisville, Kentucky, 40241-2832, United States

Location

Local Institution - 0044

Silver Spring, Maryland, 20904-7917, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202-2608, United States

Location

Local Institution - 0002

Kansas City, Missouri, 64132, United States

Location

Local Institution - 0011

Charlotte, North Carolina, 28207, United States

Location

Local Institution - 0034

Arlington, Texas, 76012-2510, United States

Location

Local Institution - 0045

Flower Mound, Texas, 75028-1713, United States

Location

Local Institution - 0033

Fairfax, Virginia, 22031-4629, United States

Location

Local Institution - 0040

Wollongong, NS, 2500, Australia

Location

Local Institution - 0012

Ballarat Central, Victoria, 3350, Australia

Location

Local Institution - 0022

Murdoch, Western Australia, 6150, Australia

Location

Local Institution - 0039

Mons, WHT, 7000, Belgium

Location

Local Institution - 0036

Roeselare, 8800, Belgium

Location

Local Institution - 0028

Providencia, SA, 7500653, Chile

Location

Local Institution - 0030

Independencia, 8380456, Chile

Location

Local Institution - 0027

Recoleta, 8420383, Chile

Location

Local Institution - 0023

Santiago, 7500921, Chile

Location

Local Institution - 0017

Rouen, 76000, France

Location

Local Institution - 0015

Suresnes, 92151, France

Location

Local Institution - 0014

Toulon, 83056, France

Location

Local Institution - 0038

Villejuif, 94805, France

Location

Local Institution - 0020

Málaga, MA, 29010, Spain

Location

Local Institution - 0019

Majadahonda (Madrid), M, 28222, Spain

Location

Local Institution - 0025

Barcelona, 08035, Spain

Location

Local Institution - 0021

Barcelona, 08036, Spain

Location

Local Institution - 0018

Madrid, 28041, Spain

Location

Local Institution - 0026

Santiago de Compostela, 15706, Spain

Location

Local Institution - 0031

Seville, 41013, Spain

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Adenocarcinoma

Interventions

MORAb-202

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 13, 2022
• Study Start: November 14, 2022
• Primary Completion: August 12, 2024
• Study Completion: August 12, 2024
• Last Updated: September 4, 2025
• Results First Posted: September 4, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (13); AU (3); BE (2); ES (7); CL (4); FR (4)