Trial Title:
A Study of MORAb-202 in Participants With Previously Treated Metastatic Non-Small Cell Lung Cancer (NSCLC) Adenocarcinoma (AC)
NCT ID:
NCT05577715
Condition:
Carcinoma, Non-Small-Cell Lung
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Adenocarcinoma
Farletuzumab
Conditions: Keywords:
NSCLC
MORAb-202
Farletuzumab ecteribulin
Adenocarcinoma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
MORAb-202
Description:
Specified dose on specified days
Arm group label:
MORAb-202
Other name:
Farletuzumab Ecteribulin
Other name:
BMS-986445
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Rocky Mountain Cancer Centers - Lone Tree
Address:
City:
Lone Tree
Zip:
80124
Country:
United States
Status:
Recruiting
Contact:
Last name:
Robert Jotte, Site 0035
Phone:
303-388-4876
Facility:
Name:
Clermont Oncology Center
Address:
City:
Clermont
Zip:
34711-6699
Country:
United States
Status:
Recruiting
Contact:
Last name:
Gopal Kunta, Site 0043
Phone:
352-242-1366
Facility:
Name:
Mid Florida Cancer Center - Orange City
Address:
City:
Orange City
Zip:
32763-8316
Country:
United States
Status:
Recruiting
Contact:
Last name:
Santosh Nair, Site 0010
Phone:
13864073531915
Facility:
Name:
Northwest Georgia Oncology Centers, P.C.
Address:
City:
Marietta
Zip:
30060
Country:
United States
Status:
Recruiting
Contact:
Last name:
Steven McCune, Site 0001
Phone:
770-281-5162
Facility:
Name:
Norton Brownsboro Hospital
Address:
City:
Louisville
Zip:
40241-2832
Country:
United States
Status:
Recruiting
Contact:
Last name:
Adam Lye, Site 0005
Phone:
859-323-3000
Facility:
Name:
Maryland Oncology Hematology - Silver Spring - White Oak Cancer Center
Address:
City:
Silver Spring
Zip:
20904-7917
Country:
United States
Status:
Recruiting
Contact:
Last name:
Vinni Juneja, Site 0044
Facility:
Name:
Henry Ford Hospital
Address:
City:
Detroit
Zip:
48202-2608
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Shirish Gadgeel, Site 0004
Phone:
313-399-0508
Facility:
Name:
Mayo Clinic Rochester
Address:
City:
Rochester
Zip:
55902
Country:
United States
Status:
Withdrawn
Facility:
Name:
Texas Oncology - Arlington North
Address:
City:
Arlington
Zip:
76012-2510
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
John Adams, Site 0034
Phone:
817-261-4906
Facility:
Name:
Texas Oncology - Flower Mound
Address:
City:
Flower Mound
Zip:
75028
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Enrique Perez, Site 0045
Phone:
210-227-6156
Facility:
Name:
Virginia Cancer Specialists - Fairfax
Address:
City:
Fairfax
Zip:
22031-4629
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alexander Spira, Site 0033
Phone:
703-280-5390
Facility:
Name:
Local Institution - 0032
Address:
City:
Liverpool
Zip:
1871
Country:
Australia
Status:
Not yet recruiting
Contact:
Last name:
Site 0032
Facility:
Name:
Local Institution - 0040
Address:
City:
Wollongong
Zip:
2500
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Site 0040
Facility:
Name:
Local Institution - 0012
Address:
City:
Ballarat Central
Zip:
3350
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Site 0012
Facility:
Name:
Local Institution - 0022
Address:
City:
Murdoch
Zip:
6150
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Site 0022
Facility:
Name:
Local Institution - 0036
Address:
City:
Roeselare
Zip:
8800
Country:
Belgium
Status:
Not yet recruiting
Contact:
Last name:
Site 0036
Facility:
Name:
Local Institution - 0024
Address:
City:
Charleroi
Zip:
6000
Country:
Belgium
Status:
Withdrawn
Facility:
Name:
Local Institution - 0028
Address:
City:
Providencia
Zip:
7500653
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Site 0028
Facility:
Name:
Local Institution - 0030
Address:
City:
Independencia
Zip:
8380456
Country:
Chile
Status:
Not yet recruiting
Contact:
Last name:
Site 0030
Facility:
Name:
Local Institution - 0027
Address:
City:
Recoleta
Zip:
8420383
Country:
Chile
Status:
Not yet recruiting
Contact:
Last name:
Site 0027
Facility:
Name:
Local Institution - 0023
Address:
City:
Santiago
Zip:
7500921
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Site 0023
Facility:
Name:
Local Institution - 0037
Address:
City:
Paris
Zip:
75005
Country:
France
Status:
Withdrawn
Facility:
Name:
Local Institution - 0017
Address:
City:
Rouen Cedex
Zip:
76000
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Site 0017
Facility:
Name:
Local Institution - 0029
Address:
City:
Saint Herblain
Zip:
44805
Country:
France
Status:
Withdrawn
Facility:
Name:
Local Institution - 0015
Address:
City:
Suresnes
Zip:
92151
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Site 0015
Facility:
Name:
Local Institution - 0038
Address:
City:
Villejuif
Zip:
94805
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Site 0038
Facility:
Name:
Local Institution - 0020
Address:
City:
Malaga
Zip:
29010
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Site 0020
Facility:
Name:
Local Institution - 0021
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Site 0021
Facility:
Name:
Local Institution - 0025
Address:
City:
Barcelone
Zip:
08035
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Site 0025
Facility:
Name:
Local Institution - 0018
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Site 0018
Facility:
Name:
Local Institution - 0019
Address:
City:
Madrid
Zip:
28222
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Site 0019
Facility:
Name:
Local Institution - 0026
Address:
City:
Santiago de Compostela
Zip:
15706
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Site 0026
Facility:
Name:
Local Institution - 0031
Address:
City:
Seville
Zip:
41013
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Site 0031
Start date:
November 14, 2022
Completion date:
February 28, 2026
Lead sponsor:
Agency:
Bristol-Myers Squibb
Agency class:
Industry
Collaborator:
Agency:
Eisai Inc.
Agency class:
Industry
Source:
Bristol-Myers Squibb
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05577715
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
https://www.bmsstudyconnect.com/s/US/English/USenHome
http://www.fda.gov/safety/medwatch/safetyinformation/default.htm
