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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT05577715
Ethics application status
Date submitted
10/10/2022
Date registered
13/10/2022

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
Trial website
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
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
See Plan Description
Available to whom?
See Plan Description
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05577715