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

Primary Purpose

Carcinoma, Non-Small-Cell Lung

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MORAb-202
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring NSCLC, MORAb-202, Farletuzumab ecteribulin, Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically or cytologically documented metastatic NSCLC AC (as defined by the 8th International Association for the Study of Lung Cancer Classification).
  • Participants without genetic alterations or unknown genetic alterations in the metastatic setting after receiving:

    i) 1 prior line of therapy if platinum-doublet chemotherapy and anti-PD-1/PD-L1 were given concurrently or ii) 2 prior lines of therapy if platinum-doublet chemotherapy and anti-PD-1/PD-L1 were given sequentially.

  • Participants with known targetable genetic alterations in the metastatic setting after receiving:

    i) At least 1 approved targeted therapy and ii) No more than 3 prior lines of systemic therapy (including no more than 1 line of chemotherapy).

  • Either FFPE tissue block (preferred), newly cut unstained slides or newly obtained biopsies must be available for assessment by IHC at a central laboratory prior to randomization.

Exclusion Criteria:

  • NSCLC histologies other than AC (ie, squamous cell carcinoma, large cell carcinoma).
  • Pulmonary function test (PFT) abnormalities: Forced expiratory volume during first second of forced breath (FEV1) < 70%, or forced vital capacity (FVC) < 60%, and diffusing capacity of the lung for carbon monoxide (DLCO) < 80%.
  • 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.

Sites / Locations

  • Rocky Mountain Cancer Centers - Lone TreeRecruiting
  • Clermont Oncology CenterRecruiting
  • Mid Florida Cancer Center - Orange CityRecruiting
  • Northwest Georgia Oncology Centers, P.C.Recruiting
  • Norton Brownsboro HospitalRecruiting
  • Maryland Oncology Hematology - Silver Spring - White Oak Cancer CenterRecruiting
  • Henry Ford Hospital
  • Mayo Clinic Rochester
  • Texas Oncology - Arlington North
  • Texas Oncology - Flower Mound
  • Virginia Cancer Specialists - FairfaxRecruiting
  • Local Institution - 0032
  • Local Institution - 0040Recruiting
  • Local Institution - 0012Recruiting
  • Local Institution - 0022Recruiting
  • Local Institution - 0036
  • Local Institution - 0024
  • Local Institution - 0028Recruiting
  • Local Institution - 0030
  • Local Institution - 0027
  • Local Institution - 0023Recruiting
  • Local Institution - 0037
  • Local Institution - 0017
  • Local Institution - 0029
  • Local Institution - 0015
  • Local Institution - 0038
  • Local Institution - 0020Recruiting
  • Local Institution - 0021Recruiting
  • Local Institution - 0025Recruiting
  • Local Institution - 0018Recruiting
  • Local Institution - 0019Recruiting
  • Local Institution - 0026
  • Local Institution - 0031Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MORAb-202

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 10, 2022
Last Updated
July 17, 2023
Sponsor
Bristol-Myers Squibb
Collaborators
Eisai Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05577715
Brief Title
A Study of MORAb-202 in Participants With Previously Treated Metastatic Non-Small Cell Lung Cancer (NSCLC) Adenocarcinoma (AC)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 14, 2022 (Actual)
Primary Completion Date
March 4, 2024 (Anticipated)
Study Completion Date
February 28, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
Collaborators
Eisai Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung
Keywords
NSCLC, MORAb-202, Farletuzumab ecteribulin, Adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MORAb-202
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
MORAb-202
Other Intervention Name(s)
Farletuzumab Ecteribulin, BMS-986445
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Incidence of treatment-related adverse events (TRAEs) leading to study treatment discontinuation
Time Frame
Up to 2 years
Title
Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 per investigator assessment
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Number of participants with adverse events (AEs)
Time Frame
Up to 2 years
Title
Number of participants with serious adverse events (SAEs)
Time Frame
Up to 2 years
Title
Number of participants with treatment related AEs and SAEs
Time Frame
Up to 2 years
Title
Number of participants with AEs of special interest (AESI)
Time Frame
Up to 2 years
Title
Number of deaths
Time Frame
Up to 2 years
Title
Number of participants with clinical laboratory abnormalities
Time Frame
Up to 2 years
Title
Progression-free Survival (PFS) by RECIST 1.1 per investigator assessment
Time Frame
Up to 2 years
Title
Disease Control Rate (DCR) by RECIST 1.1 per investigator assessment
Time Frame
Up to 2 years
Title
Duration of Response (DoR) by RECIST 1.1 per investigator assessment
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone
855-907-3286
Email
Clinical.Trials@bms.com
First Name & Middle Initial & Last Name or Official Title & Degree
First line of the email MUST contain the NCT# and Site #.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Rocky Mountain Cancer Centers - Lone Tree
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Jotte, Site 0035
Phone
303-388-4876
Facility Name
Clermont Oncology Center
City
Clermont
State/Province
Florida
ZIP/Postal Code
34711-6699
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gopal Kunta, Site 0043
Phone
352-242-1366
Facility Name
Mid Florida Cancer Center - Orange City
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763-8316
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Santosh Nair, Site 0010
Phone
13864073531915
Facility Name
Northwest Georgia Oncology Centers, P.C.
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven McCune, Site 0001
Phone
770-281-5162
Facility Name
Norton Brownsboro Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241-2832
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Lye, Site 0005
Phone
859-323-3000
Facility Name
Maryland Oncology Hematology - Silver Spring - White Oak Cancer Center
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20904-7917
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vinni Juneja, Site 0044
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202-2608
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shirish Gadgeel, Site 0004
Phone
313-399-0508
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Individual Site Status
Withdrawn
Facility Name
Texas Oncology - Arlington North
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012-2510
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Adams, Site 0034
Phone
817-261-4906
Facility Name
Texas Oncology - Flower Mound
City
Flower Mound
State/Province
Texas
ZIP/Postal Code
75028
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enrique Perez, Site 0045
Phone
210-227-6156
Facility Name
Virginia Cancer Specialists - Fairfax
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031-4629
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Spira, Site 0033
Phone
703-280-5390
Facility Name
Local Institution - 0032
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
1871
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0032
Facility Name
Local Institution - 0040
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0040
Facility Name
Local Institution - 0012
City
Ballarat Central
State/Province
Victoria
ZIP/Postal Code
3350
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0012
Facility Name
Local Institution - 0022
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0022
Facility Name
Local Institution - 0036
City
Roeselare
State/Province
BL
ZIP/Postal Code
8800
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0036
Facility Name
Local Institution - 0024
City
Charleroi
State/Province
WHT
ZIP/Postal Code
6000
Country
Belgium
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0028
City
Providencia
State/Province
SA
ZIP/Postal Code
7500653
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0028
Facility Name
Local Institution - 0030
City
Independencia
ZIP/Postal Code
8380456
Country
Chile
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0030
Facility Name
Local Institution - 0027
City
Recoleta
ZIP/Postal Code
8420383
Country
Chile
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0027
Facility Name
Local Institution - 0023
City
Santiago
ZIP/Postal Code
7500921
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0023
Facility Name
Local Institution - 0037
City
Paris
ZIP/Postal Code
75005
Country
France
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0017
City
Rouen Cedex
ZIP/Postal Code
76000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0017
Facility Name
Local Institution - 0029
City
Saint Herblain
ZIP/Postal Code
44805
Country
France
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0015
City
Suresnes
ZIP/Postal Code
92151
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0015
Facility Name
Local Institution - 0038
City
Villejuif
ZIP/Postal Code
94805
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0038
Facility Name
Local Institution - 0020
City
Malaga
State/Province
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0020
Facility Name
Local Institution - 0021
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0021
Facility Name
Local Institution - 0025
City
Barcelone
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0025
Facility Name
Local Institution - 0018
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0018
Facility Name
Local Institution - 0019
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0019
Facility Name
Local Institution - 0026
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0026
Facility Name
Local Institution - 0031
City
Seville
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0031

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
http://www.fda.gov/safety/medwatch/safetyinformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

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