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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05577715




Registration number
NCT05577715
Ethics application status
Date submitted
10/10/2022
Date registered
13/10/2022
Date last updated
18/07/2023

Titles & IDs
Public title
A Study of MORAb-202 in Participants With Previously Treated Metastatic Non-Small Cell Lung Cancer (NSCLC) Adenocarcinoma (AC)
Scientific 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
Secondary ID [1] 0 0
2022-000131-23
Secondary ID [2] 0 0
CA116-003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Non-Small-Cell Lung 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MORAb-202

Experimental: MORAb-202 -


Treatment: Drugs: MORAb-202
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of treatment-related adverse events (TRAEs) leading to study treatment discontinuation
Timepoint [1] 0 0
Up to 2 years
Primary outcome [2] 0 0
Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 per investigator assessment
Timepoint [2] 0 0
Up to 2 years
Secondary outcome [1] 0 0
Number of participants with adverse events (AEs)
Timepoint [1] 0 0
Up to 2 years
Secondary outcome [2] 0 0
Number of participants with serious adverse events (SAEs)
Timepoint [2] 0 0
Up to 2 years
Secondary outcome [3] 0 0
Number of participants with treatment related AEs and SAEs
Timepoint [3] 0 0
Up to 2 years
Secondary outcome [4] 0 0
Number of participants with AEs of special interest (AESI)
Timepoint [4] 0 0
Up to 2 years
Secondary outcome [5] 0 0
Number of deaths
Timepoint [5] 0 0
Up to 2 years
Secondary outcome [6] 0 0
Number of participants with clinical laboratory abnormalities
Timepoint [6] 0 0
Up to 2 years
Secondary outcome [7] 0 0
Progression-free Survival (PFS) by RECIST 1.1 per investigator assessment
Timepoint [7] 0 0
Up to 2 years
Secondary outcome [8] 0 0
Disease Control Rate (DCR) by RECIST 1.1 per investigator assessment
Timepoint [8] 0 0
Up to 2 years
Secondary outcome [9] 0 0
Duration of Response (DoR) by RECIST 1.1 per investigator assessment
Timepoint [9] 0 0
Up to 2 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/02/2026
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0032 - Liverpool
Recruitment hospital [2] 0 0
Local Institution - 0040 - Wollongong
Recruitment hospital [3] 0 0
Local Institution - 0012 - Ballarat Central
Recruitment hospital [4] 0 0
Local Institution - 0022 - Murdoch
Recruitment postcode(s) [1] 0 0
1871 - Liverpool
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment postcode(s) [3] 0 0
3350 - Ballarat Central
Recruitment postcode(s) [4] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Virginia
Country [10] 0 0
Belgium
State/province [10] 0 0
BL
Country [11] 0 0
Belgium
State/province [11] 0 0
WHT
Country [12] 0 0
Chile
State/province [12] 0 0
SA
Country [13] 0 0
Chile
State/province [13] 0 0
Independencia
Country [14] 0 0
Chile
State/province [14] 0 0
Recoleta
Country [15] 0 0
Chile
State/province [15] 0 0
Santiago
Country [16] 0 0
France
State/province [16] 0 0
Paris
Country [17] 0 0
France
State/province [17] 0 0
Rouen Cedex
Country [18] 0 0
France
State/province [18] 0 0
Saint Herblain
Country [19] 0 0
France
State/province [19] 0 0
Suresnes
Country [20] 0 0
France
State/province [20] 0 0
Villejuif
Country [21] 0 0
Spain
State/province [21] 0 0
Málaga
Country [22] 0 0
Spain
State/province [22] 0 0
Barcelona
Country [23] 0 0
Spain
State/province [23] 0 0
Barcelone
Country [24] 0 0
Spain
State/province [24] 0 0
Madrid
Country [25] 0 0
Spain
State/province [25] 0 0
Santiago de Compostela
Country [26] 0 0
Spain
State/province [26] 0 0
Seville

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Eisai Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05577715
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BMS Study Connect Contact Center www.BMSStudyConnect.com
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Fax 0 0
Email 0 0
Clinical.Trials@bms.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05577715