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

Carcinoma, Non-Small-Cell Lung Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05577715
• Other study ID #: CA116-003
• Secondary ID: 2022-000131-23MO
• Status: Recruiting
• Phase: Phase 2
• Start date: November 14, 2022
• Est. completion date: February 28, 2026

Study information

• Verified date: July 2023
• Source: Bristol-Myers Squibb
• Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 28, 2026
• Est. primary completion date: March 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• MORAb-202
Specified dose on specified days

Locations

Country	Name	City	State
Australia	Local Institution - 0012	Ballarat Central	Victoria
Australia	Local Institution - 0032	Liverpool	New South Wales
Australia	Local Institution - 0022	Murdoch	Western Australia
Australia	Local Institution - 0040	Wollongong	New South Wales
Belgium	Local Institution - 0024	Charleroi	WHT
Belgium	Local Institution - 0036	Roeselare	BL
Chile	Local Institution - 0030	Independencia
Chile	Local Institution - 0028	Providencia	SA
Chile	Local Institution - 0027	Recoleta
Chile	Local Institution - 0023	Santiago
France	Local Institution - 0037	Paris
France	Local Institution - 0017	Rouen Cedex
France	Local Institution - 0029	Saint Herblain
France	Local Institution - 0015	Suresnes
France	Local Institution - 0038	Villejuif
Spain	Local Institution - 0021	Barcelona
Spain	Local Institution - 0025	Barcelone
Spain	Local Institution - 0018	Madrid
Spain	Local Institution - 0019	Madrid
Spain	Local Institution - 0020	Malaga	Málaga
Spain	Local Institution - 0026	Santiago de Compostela
Spain	Local Institution - 0031	Seville
United States	Texas Oncology - Arlington North	Arlington	Texas
United States	Clermont Oncology Center	Clermont	Florida
United States	Henry Ford Hospital	Detroit	Michigan
United States	Virginia Cancer Specialists - Fairfax	Fairfax	Virginia
United States	Texas Oncology - Flower Mound	Flower Mound	Texas
United States	Rocky Mountain Cancer Centers - Lone Tree	Lone Tree	Colorado
United States	Norton Brownsboro Hospital	Louisville	Kentucky
United States	Northwest Georgia Oncology Centers, P.C.	Marietta	Georgia
United States	Mid Florida Cancer Center - Orange City	Orange City	Florida
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	Maryland Oncology Hematology - Silver Spring - White Oak Cancer Center	Silver Spring	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Eisai Inc.

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Chile,  France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-related adverse events (TRAEs) leading to study treatment discontinuation		Up to 2 years
Primary	Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 per investigator assessment		Up to 2 years
Secondary	Number of participants with adverse events (AEs)		Up to 2 years
Secondary	Number of participants with serious adverse events (SAEs)		Up to 2 years
Secondary	Number of participants with treatment related AEs and SAEs		Up to 2 years
Secondary	Number of participants with AEs of special interest (AESI)		Up to 2 years
Secondary	Number of deaths		Up to 2 years
Secondary	Number of participants with clinical laboratory abnormalities		Up to 2 years
Secondary	Progression-free Survival (PFS) by RECIST 1.1 per investigator assessment		Up to 2 years
Secondary	Disease Control Rate (DCR) by RECIST 1.1 per investigator assessment		Up to 2 years
Secondary	Duration of Response (DoR) by RECIST 1.1 per investigator assessment		Up to 2 years

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls