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

Phase 2

Terminated

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: MORAb-202

• Registration Number: NCT05577715
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-10
• Study First Submitted QC: 2022-10-10
• Study First Posted: 2022-10-13
• Study Start: 2022-11-14
• Primary Completion: 2024-08-12
• Study Completion: 2024-08-12
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MORAb-202	MORAb-202	-

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 per investigator assessment	Up to 2 years
Incidence of treatment-related adverse events (TRAEs) leading to study treatment discontinuation	Up to 2 years

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS) by RECIST 1.1 per investigator assessment	Up to 2 years
Duration of Response (DoR) by RECIST 1.1 per investigator assessment	Up to 2 years
Number of participants with serious adverse events (SAEs)	Up to 2 years
Number of participants with clinical laboratory abnormalities	Up to 2 years
Number of participants with adverse events (AEs)	Up to 2 years
Number of participants with treatment related AEs and SAEs	Up to 2 years
Number of deaths	Up to 2 years
Disease Control Rate (DCR) by RECIST 1.1 per investigator assessment	Up to 2 years
Number of participants with AEs of special interest (AESI)	Up to 2 years

Trial Locations

Locations (29)

Rocky Mountain Cancer Centers - Lone Tree; 🇺🇸 Lone Tree, Colorado, United States

Clermont Oncology Center; 🇺🇸 Clermont, Florida, United States

Mid Florida Cancer Center - Orange City; 🇺🇸 Orange City, Florida, United States

Northwest Georgia Oncology Centers, P.C.; 🇺🇸 Marietta, Georgia, United States

Norton Brownsboro Hospital; 🇺🇸 Louisville, Kentucky, United States

Maryland Oncology Hematology - Silver Spring - White Oak Cancer Center; 🇺🇸 Silver Spring, Maryland, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

Texas Oncology - Arlington North; 🇺🇸 Arlington, Texas, United States

Texas Oncology - Flower Mound; 🇺🇸 Flower Mound, Texas, United States

Virginia Cancer Specialists - Fairfax; 🇺🇸 Fairfax, Virginia, United States

Local Institution - 0032; 🇦🇺 Liverpool, New South Wales, Australia

Local Institution - 0040; 🇦🇺 Wollongong, New South Wales, Australia

Local Institution - 0012; 🇦🇺 Ballarat Central, Victoria, Australia

Local Institution - 0022; 🇦🇺 Murdoch, Western Australia, Australia

Local Institution - 0036; 🇧🇪 Roeselare, BL, Belgium

Local Institution - 0028; 🇨🇱 Providencia, SA, Chile

Local Institution - 0030; 🇨🇱 Independencia, Chile

Local Institution - 0027; 🇨🇱 Recoleta, Chile

Local Institution - 0023; 🇨🇱 Santiago, Chile

Local Institution - 0017; 🇫🇷 Rouen Cedex, France

Local Institution - 0015; 🇫🇷 Suresnes, France

Local Institution - 0020; 🇪🇸 Malaga, Málaga, Spain

Local Institution - 0038; 🇫🇷 Villejuif, France

Local Institution - 0021; 🇪🇸 Barcelona, Spain

Local Institution - 0025; 🇪🇸 Barcelone, Spain

Local Institution - 0018; 🇪🇸 Madrid, Spain

Local Institution - 0019; 🇪🇸 Madrid, Spain

Local Institution - 0026; 🇪🇸 Santiago de Compostela, Spain

Local Institution - 0031; 🇪🇸 Seville, Spain