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

Study Overview
=================
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.

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

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
-----------------
* Drug: MORAb-202


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MORAb-202<br> | Drug: MORAb-202<br>* Specified dose on specified days<br>* Other names: BMS-986445;|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NSCLC, MORAb-202, Farletuzumab ecteribulin, Adenocarcinoma