Carcinoma, Non-Small-Cell Lung Clinical Trial
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
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.
| Status | Recruiting |
| Enrollment | 50 |
| Est. completion date | February 28, 2026 |
| Est. primary completion date | March 4, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Local Institution - 0012 | Ballarat Central | Victoria |
| Australia | Local Institution - 0032 | Liverpool | New South Wales |
| Australia | Local Institution - 0022 | Murdoch | Western Australia |
| Australia | Local Institution - 0040 | Wollongong | New South Wales |
| Belgium | Local Institution - 0024 | Charleroi | WHT |
| Belgium | Local Institution - 0036 | Roeselare | BL |
| Chile | Local Institution - 0030 | Independencia | |
| Chile | Local Institution - 0028 | Providencia | SA |
| Chile | Local Institution - 0027 | Recoleta | |
| Chile | Local Institution - 0023 | Santiago | |
| France | Local Institution - 0037 | Paris | |
| France | Local Institution - 0017 | Rouen Cedex | |
| France | Local Institution - 0029 | Saint Herblain | |
| France | Local Institution - 0015 | Suresnes | |
| France | Local Institution - 0038 | Villejuif | |
| Spain | Local Institution - 0021 | Barcelona | |
| Spain | Local Institution - 0025 | Barcelone | |
| Spain | Local Institution - 0018 | Madrid | |
| Spain | Local Institution - 0019 | Madrid | |
| Spain | Local Institution - 0020 | Malaga | Málaga |
| Spain | Local Institution - 0026 | Santiago de Compostela | |
| Spain | Local Institution - 0031 | Seville | |
| United States | Texas Oncology - Arlington North | Arlington | Texas |
| United States | Clermont Oncology Center | Clermont | Florida |
| United States | Henry Ford Hospital | Detroit | Michigan |
| United States | Virginia Cancer Specialists - Fairfax | Fairfax | Virginia |
| United States | Texas Oncology - Flower Mound | Flower Mound | Texas |
| United States | Rocky Mountain Cancer Centers - Lone Tree | Lone Tree | Colorado |
| United States | Norton Brownsboro Hospital | Louisville | Kentucky |
| United States | Northwest Georgia Oncology Centers, P.C. | Marietta | Georgia |
| United States | Mid Florida Cancer Center - Orange City | Orange City | Florida |
| United States | Mayo Clinic Rochester | Rochester | Minnesota |
| United States | Maryland Oncology Hematology - Silver Spring - White Oak Cancer Center | Silver Spring | Maryland |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb | Eisai Inc. |
United States, Australia, Belgium, Chile, France, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of treatment-related adverse events (TRAEs) leading to study treatment discontinuation | Up to 2 years | ||
| Primary | Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 per investigator assessment | Up to 2 years | ||
| Secondary | Number of participants with adverse events (AEs) | Up to 2 years | ||
| Secondary | Number of participants with serious adverse events (SAEs) | Up to 2 years | ||
| Secondary | Number of participants with treatment related AEs and SAEs | Up to 2 years | ||
| Secondary | Number of participants with AEs of special interest (AESI) | Up to 2 years | ||
| Secondary | Number of deaths | Up to 2 years | ||
| Secondary | Number of participants with clinical laboratory abnormalities | Up to 2 years | ||
| Secondary | Progression-free Survival (PFS) by RECIST 1.1 per investigator assessment | Up to 2 years | ||
| Secondary | Disease Control Rate (DCR) by RECIST 1.1 per investigator assessment | Up to 2 years | ||
| Secondary | Duration of Response (DoR) by RECIST 1.1 per investigator assessment | Up to 2 years |
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