Clinical trial NCT05577715: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: NSCLC
MORAb-202
Farletuzumab ecteribulin
Adenocarcinoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Eisai Inc.
First posted: 2022-10-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Incidence of treatment-related adverse events (TRAEs) leading to study treatment discontinuation
timeFrame: Up to 2 years
measure: Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 per investigator assessment
timeFrame: Up to 2 years
Secondary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 2 years
measure: Number of participants with serious adverse events (SAEs)
timeFrame: Up to 2 years
measure: Number of participants with treatment related AEs and SAEs
timeFrame: Up to 2 years
measure: Number of participants with AEs of special interest (AESI)
timeFrame: Up to 2 years
measure: Number of deaths
timeFrame: Up to 2 years
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to 2 years
measure: Progression-free Survival (PFS) by RECIST 1.1 per investigator assessment
timeFrame: Up to 2 years
measure: Disease Control Rate (DCR) by RECIST 1.1 per investigator assessment
timeFrame: Up to 2 years
measure: Duration of Response (DoR) by RECIST 1.1 per investigator assessment
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Lone Tree
country: United States
facility: Rocky Mountain Cancer Centers - Lone Tree
state: Colorado
city: Clermont
country: United States
facility: Clermont Oncology Center
state: Florida
city: Orange City
country: United States
facility: Mid Florida Cancer Center - Orange City
state: Florida
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers, P.C.
state: Georgia
city: Louisville
country: United States
facility: Norton Brownsboro Hospital
state: Kentucky
city: Silver Spring
country: United States
facility: Maryland Oncology Hematology - Silver Spring - White Oak Cancer Center
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Arlington
country: United States
facility: Texas Oncology - Arlington North
state: Texas
city: Flower Mound
country: United States
facility: Texas Oncology - Flower Mound
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists - Fairfax
state: Virginia
city: Liverpool
country: Australia
facility: Local Institution - 0032
state: New South Wales
city: Wollongong
country: Australia
facility: Local Institution - 0040
state: New South Wales
city: Ballarat Central
country: Australia
facility: Local Institution - 0012
state: Victoria
city: Murdoch
country: Australia
facility: Local Institution - 0022
state: Western Australia
city: Roeselare
country: Belgium
facility: Local Institution - 0036
state: BL
city: Providencia
country: Chile
facility: Local Institution - 0028
state: SA
city: Independencia
country: Chile
facility: Local Institution - 0030
city: Recoleta
country: Chile
facility: Local Institution - 0027
city: Santiago
country: Chile
facility: Local Institution - 0023
city: Rouen Cedex
country: France
facility: Local Institution - 0017
city: Suresnes
country: France
facility: Local Institution - 0015
city: Villejuif
country: France
facility: Local Institution - 0038
city: Malaga
country: Spain
facility: Local Institution - 0020
state: Málaga
city: Barcelona
country: Spain
facility: Local Institution - 0021
city: Barcelone
country: Spain
facility: Local Institution - 0025
city: Madrid
country: Spain
facility: Local Institution - 0018
city: Madrid
country: Spain
facility: Local Institution - 0019
city: Santiago de Compostela
country: Spain
facility: Local Institution - 0026
city: Seville
country: Spain
facility: Local Institution - 0031
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: