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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05577715
Collaborator
Eisai Inc. (Industry)
100
Enrollment
22
Locations
2
Arms
40.1
Anticipated Duration (Months)
4.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
Anticipated 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 :
Nov 14, 2022
Anticipated Primary Completion Date :
Apr 4, 2024
Anticipated Study Completion Date :
Mar 18, 2026

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of treatment-related adverse events (TRAEs) leading to study treatment discontinuation [Up to 2 years]

    2. Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 per investigator assessment [Up to 2 years]

    Secondary Outcome Measures

    1. Number of participants with adverse events (AEs) [Up to 2 years]

    2. Number of participants with serious adverse events (SAEs) [Up to 2 years]

    3. Number of participants with treatment related AEs and SAEs [Up to 2 years]

    4. Number of participants with AEs of special interest (AESI) [Up to 2 years]

    5. Number of deaths [Up to 2 years]

    6. Number of participants with clinical laboratory abnormalities [Up to 2 years]

    7. Progression-free Survival (PFS) by RECIST 1.1 per investigator assessment [Up to 2 years]

    8. Disease Control Rate (DCR) by RECIST 1.1 per investigator assessment [Up to 2 years]

    9. Duration of Response (DoR) by RECIST 1.1 per investigator assessment [Up to 2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    1. 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:
    1. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rocky Mountain Cancer Centers (Lone Tree) - USOR Lone Tree Colorado United States 80124
    2 Clermont Oncology Center Clermont Florida United States 34711-6699
    3 Mid-Florida Cancer Center Sanford Florida United States 32763
    4 Northwest Georgia Oncology Centers, P.C. Marietta Georgia United States 30060
    5 Maryland Oncology Hematology - Silver Spring - White Oak Cancer Center Silver Spring Maryland United States 20904-7917
    6 Henry Ford Hospital Detroit Michigan United States 48202-2608
    7 Mayo Clinic- Rochester Rochester Minnesota United States 55905
    8 Texas Oncology - Arlington North Arlington Texas United States 76012-2510
    9 Texas Oncology - Flower Mound Flower Mound Texas United States 75028
    10 Virginia Cancer Specialists, PC Fairfax Fairfax Virginia United States 22031-4629
    11 Local Institution - 0032 Liverpool New South Wales Australia 1871
    12 Local Institution - 0040 Wollongong New South Wales Australia 2500
    13 Local Institution - 0036 Roeselare BL Belgium 8800
    14 Local Institution - 0024 Charleroi WHT Belgium 6000
    15 Local Institution - 0030 Independencia Santiago Chile 8380456
    16 Local Institution - 0027 Recoleta Chile 8420383
    17 Local Institution - 0037 Paris France 75248
    18 Local Institution - 0029 Saint Herblain France 44805
    19 Local Institution - 0038 Villejuif France 94805
    20 Local Institution - 0018 Madrid Spain 28041
    21 Local Institution - 0026 Santiago de Compostela Spain 15706
    22 Local Institution - 0031 Seville Spain 41013

    Sponsors and Collaborators

    • Bristol-Myers Squibb
    • Eisai Inc.

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT05577715
    Other Study ID Numbers:
    • CA116-003
    • 2022-000131-23
    • MORAb-202-G000-203
    First Posted:
    Oct 13, 2022
    Last Update Posted:
    Jan 18, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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:
    Carcinoma, Non-Small-Cell Lung
    Adenocarcinoma
    Farletuzumab

    Study Results

    No Results Posted as of Jan 18, 2023