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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 : January 18, 2023
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: MORAb-202 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 14, 2022
Estimated Primary Completion Date : April 4, 2024
Estimated Study Completion Date : March 18, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MORAb-202 Dose 1 Drug: MORAb-202
Specified dose on specified days
Other Names:
  • Farletuzumab Ecteribulin
  • BMS-986445

Experimental: MORAb-202 Dose 2 Drug: MORAb-202
Specified dose on specified days
Other Names:
  • Farletuzumab Ecteribulin
  • BMS-986445




Primary Outcome Measures :
  1. Incidence of treatment-related adverse events (TRAEs) leading to study treatment discontinuation [ Time Frame: Up to 2 years ]
  2. Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 per investigator assessment [ Time Frame: Up to 2 years ]

Secondary Outcome Measures :
  1. Number of participants with adverse events (AEs) [ Time Frame: Up to 2 years ]
  2. Number of participants with serious adverse events (SAEs) [ Time Frame: Up to 2 years ]
  3. Number of participants with treatment related AEs and SAEs [ Time Frame: Up to 2 years ]
  4. Number of participants with AEs of special interest (AESI) [ Time Frame: Up to 2 years ]
  5. Number of deaths [ Time Frame: Up to 2 years ]
  6. Number of participants with clinical laboratory abnormalities [ Time Frame: Up to 2 years ]
  7. Progression-free Survival (PFS) by RECIST 1.1 per investigator assessment [ Time Frame: Up to 2 years ]
  8. Disease Control Rate (DCR) by RECIST 1.1 per investigator assessment [ Time Frame: Up to 2 years ]
  9. Duration of Response (DoR) by RECIST 1.1 per investigator assessment [ Time Frame: Up to 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically documented metastatic NSCLC AC (as defined by the 8th International Association for the Study of Lung Cancer Classification).
  • Participants without genetic alterations or unknown genetic alterations in the metastatic setting after receiving:

    i) 1 prior line of therapy if platinum-doublet chemotherapy and anti-PD-1/PD-L1 were given concurrently or ii) 2 prior lines of therapy if platinum-doublet chemotherapy and anti-PD-1/PD-L1 were given sequentially.

  • Participants with known targetable genetic alterations in the metastatic setting after receiving:

    i) At least 1 approved targeted therapy and ii) No more than 3 prior lines of systemic therapy (including no more than 1 line of chemotherapy).

  • Either FFPE tissue block (preferred), newly cut unstained slides or newly obtained biopsies must be available for assessment by IHC at a central laboratory prior to randomization.

Exclusion Criteria:

  • NSCLC histologies other than AC (ie, squamous cell carcinoma, large cell carcinoma).
  • Pulmonary function test (PFT) abnormalities: Forced expiratory volume during first second of forced breath (FEV1) < 70%, or forced vital capacity (FVC) < 60%, and diffusing capacity of the lung for carbon monoxide (DLCO) < 80%.
  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05577715


Contacts
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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 #.

Locations
Show Show 22 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Eisai Inc.
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT05577715    
Other Study ID Numbers: CA116-003
2022-000131-23 ( EudraCT Number )
MORAb-202-G000-203 ( Other Identifier: Eisai Protocol Number )
First Posted: October 13, 2022    Key Record Dates
Last Update Posted: January 18, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
NSCLC
MORAb-202
Farletuzumab ecteribulin
Adenocarcinoma
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Adenocarcinoma
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Farletuzumab
Antineoplastic Agents