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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05577715
Recruitment Status : Recruiting
First Posted : October 13, 2022
Last Update Posted : July 18, 2023
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE October 10, 2022
First Posted Date  ICMJE October 13, 2022
Last Update Posted Date July 18, 2023
Actual Study Start Date  ICMJE November 14, 2022
Estimated Primary Completion Date March 4, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2022)
  • Incidence of treatment-related adverse events (TRAEs) leading to study treatment discontinuation [ Time Frame: Up to 2 years ]
  • Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 per investigator assessment [ Time Frame: Up to 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2022)
  • Number of participants with adverse events (AEs) [ Time Frame: Up to 2 years ]
  • Number of participants with serious adverse events (SAEs) [ Time Frame: Up to 2 years ]
  • Number of participants with treatment related AEs and SAEs [ Time Frame: Up to 2 years ]
  • Number of participants with AEs of special interest (AESI) [ Time Frame: Up to 2 years ]
  • Number of deaths [ Time Frame: Up to 2 years ]
  • Number of participants with clinical laboratory abnormalities [ Time Frame: Up to 2 years ]
  • Progression-free Survival (PFS) by RECIST 1.1 per investigator assessment [ Time Frame: Up to 2 years ]
  • Disease Control Rate (DCR) by RECIST 1.1 per investigator assessment [ Time Frame: Up to 2 years ]
  • Duration of Response (DoR) by RECIST 1.1 per investigator assessment [ Time Frame: Up to 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of MORAb-202 in Participants With Previously Treated Metastatic Non-Small Cell Lung Cancer (NSCLC) Adenocarcinoma (AC)
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE Drug: MORAb-202
Specified dose on specified days
Other Names:
  • Farletuzumab Ecteribulin
  • BMS-986445
Study Arms  ICMJE Experimental: MORAb-202
Intervention: Drug: MORAb-202
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 12, 2023)
50
Original Estimated Enrollment  ICMJE
 (submitted: October 10, 2022)
100
Estimated Study Completion Date  ICMJE February 28, 2026
Estimated Primary Completion Date March 4, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain the NCT# and Site #.
Listed Location Countries  ICMJE Australia,   Belgium,   Chile,   France,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05577715
Other Study ID Numbers  ICMJE CA116-003
2022-000131-23 ( EudraCT Number )
MORAb-202-G000-203 ( Other Identifier: Eisai Protocol Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: 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 Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: See Plan Description
Access Criteria: See Plan Description
URL: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
Current Responsible Party Bristol-Myers Squibb
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Bristol-Myers Squibb
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Eisai Inc.
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date July 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP