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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
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

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
GroupInterventionDescription
MORAb-202MORAb-202-
Primary Outcome Measures
NameTimeMethod
Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 per investigator assessmentUp to 2 years
Incidence of treatment-related adverse events (TRAEs) leading to study treatment discontinuationUp to 2 years
Secondary Outcome Measures
NameTimeMethod
Progression-free Survival (PFS) by RECIST 1.1 per investigator assessmentUp to 2 years
Duration of Response (DoR) by RECIST 1.1 per investigator assessmentUp to 2 years
Number of participants with serious adverse events (SAEs)Up to 2 years
Number of participants with clinical laboratory abnormalitiesUp to 2 years
Number of participants with adverse events (AEs)Up to 2 years
Number of participants with treatment related AEs and SAEsUp to 2 years
Disease Control Rate (DCR) by RECIST 1.1 per investigator assessmentUp to 2 years
Number of participants with AEs of special interest (AESI)Up to 2 years
Number of deathsUp 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

Scroll for more (19 remaining)
Rocky Mountain Cancer Centers - Lone Tree
🇺🇸Lone Tree, Colorado, United States

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