A Study of Bemarituzumab Monotherapy and Combination With Other Anti-cancer Therapy in SqNSCLC With FGFR2b Overexpression (FORTITUDE-201)
NCT ID: NCT05267470
Last Updated: 2025-03-25
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1
74 participants
INTERVENTIONAL
2022-03-29
2024-05-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1: Combination Dose Exploration
Participants with SqNSCLC will receive escalating doses of bemarituzumab in combination with docetaxel.
Bemarituzumab
Intravenous (IV) infusion
Docetaxel
IV infusion
Part 2: Combination Dose Expansion
Participants with SqNSCLC and FGFR2b overexpression will receive the dose of bemarituzumab in combination with docetaxel identified as safe during Part 1.
Bemarituzumab
Intravenous (IV) infusion
Docetaxel
IV infusion
Part 3: Bemarituzumab Monotherapy
Participants with SqNSCLC and FGFR2b overexpression will receive bemarituzumab monotherapy.
Bemarituzumab
Intravenous (IV) infusion
Part 4: Combination Immuno-chemotherapy
Participants with FGFR2b overexpression will receive the dose of bemarituzumab identified as safe during Part 1 in combination with pembrolizumab, carboplatin and either paclitaxel or nab-paclitaxel.
Bemarituzumab
Intravenous (IV) infusion
Pembrolizumab
IV infusion
Carboplatin
IV infusion
Paclitaxel
IV infusion
Nab-paclitaxel
IV infusion
Interventions
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Bemarituzumab
Intravenous (IV) infusion
Docetaxel
IV infusion
Pembrolizumab
IV infusion
Carboplatin
IV infusion
Paclitaxel
IV infusion
Nab-paclitaxel
IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years old (or legal adult within country, whichever is older) at the time that the Informed Consent Form (ICF) is signed
* Pathologically confirmed squamous cell lung carcinoma
* Disease that is unresectable, locally advanced or metastatic (not amenable to curative therapy)
* Participants must have archived tumor tissue sample (formalin fixed, paraffin embedded \[FFPE\] sample \[FFPE of excisional, or core needle\]) taken within last 5 years or be willing to undergo pre-treatment tumor biopsy (excisional, or core needle) for tissue prior to enrollment
* Participant must have progressed on, or recurred after at least 1 prior systemic therapy (Part 1 and 2 only) or at least 2 prior systemic therapies (Part 3 only) for locally advanced and unresectable or metastatic disease. Prior treatment must include a platinum-based doublet chemotherapy and checkpoint inhibitor for advanced or metastatic disease, either given as one line of therapy or as individual lines of therapy, unless the participant has a medical contraindication to one of the required therapies (which must be documented in the electronic case report form \[eCRF\]). Additionally, if the participant's tumor was previously identified as having a driver mutation (according to local standard of care or guidelines, e.g., Kirsten rat sarcoma \[KRAS\] G12C, neurotrophic tyrosine receptor kinase \[NTRK\]), which has an approved therapy for which the participant is eligible and available, the participant must have received the approved therapy in a prior line of treatment.
* For Part 4, participants may not have received prior systemic therapy for their locally advanced and unresectable or metastatic disease. For Part 4, participants who received peri-operative systemic therapy are eligible if that adjuvant/neoadjuvant therapy was completed at least 12 months prior to diagnosis of locally advanced and unresectable or metastatic disease.
* Measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate organ function as determined per protocol
* Part 2, 3 and 4 only: FGFR2b overexpression as determined by centrally performed immunohistochemistry (IHC) testing
Exclusion Criteria
* Untreated or symptomatic central nervous system (CNS) metastases or leptomeningeal disease
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures at a frequency greater than monthly
* Impaired cardiac function or clinically significant cardiac disease including: unstable angina within 6 months prior to first dose of study treatment, acute myocardial infarction \< 6 months prior to first dose of study treatment, New York Heart Association (NYHA) class II-IV congestive heart failure, uncontrolled hypertension (defined as an average systolic blood pressure \>160 mmHg or diastolic \>100 mm Hg despite optimal treatment (measured following European Society for Hypertension/European Society of Cardiology \[ESH/ESC\] 2013 guidelines; Section 11.11), uncontrolled cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, active coronary artery disease, Fridericia's correction formula (QTc) ≥ 470
* Evidence of any ongoing ophthalmologic abnormalities or symptoms that are acute (within 4 weeks) or actively progressing
* Recent (within 6 months) corneal surgery or ophthalmic laser treatment or recent (within 6 months) history of, or evidence of, corneal defects, corneal ulcerations, keratitis, or keratoconus, or other known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer
* Part 1 and Part 2: participants that experienced toxicity or hypersensitivity requiring discontinuation of prior docetaxel treatment
* Part 1 only: participants that had disease progression on prior therapy with docetaxel
* Part 2 only: participants have received prior docetaxel in unresectable or metastatic setting (including participants who received prior docetaxel in first line for metastatic disease, but not including participants who received prior docetaxel neoadjuvantly or adjuvantly and did not progress within 6 months of end of therapy)
* Prior treatment with any selective inhibitor of the fibroblast growth factor-fibroblast growth factor receptor (FGF-FGFR) pathway
18 Years
99 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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University of California Irvine
Orange, California, United States
Morristown Medical Center
Morristown, New Jersey, United States
Montefiore Einstein Center for Cancer Care
The Bronx, New York, United States
University of Pittsburgh, Cancer Institute
Pittsburgh, Pennsylvania, United States
Cliniques Universitaires Saint Luc
Brussels, , Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt, , Belgium
Institut Bergonie
Bordeaux, , France
CHU de Lyon - Hopital Louis Pradel
Bron, , France
Hôpital Tenon
Paris, , France
Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie
Poitiers, , France
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
Rennes, , France
Institut Gustave Roussy
Villejuif, , France
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
Shizuoka Cancer Center
Sunto-gun, Shizuoka, Japan
Wakayama Medical University Hospital
Wakayama, Wakayama, Japan
Przychodnia Lekarska Komed Roman Karaszewski
Konin, , Poland
Pratia Mcm Krakow
Krakow, , Poland
Krakowskie Centrum Medyczne Sp zoo
Krakow, , Poland
Instytut Centrum Zdrowia Matki Polki
Lodz, , Poland
Instytut Genetyki i Immunologii GENIM Spzoo
Lublin, , Poland
Centrum Medyczne Hope Clinic Sebastian Szklener
Lublin, , Poland
Mazowieckie centrum leczenia
Otwock, , Poland
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, , South Korea
Severance Hospital Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Hospital Regional Universitario de Malaga
Málaga, Andalusia, Spain
Hospital Universitario Virgen del Rocio
Seville, Andalusia, Spain
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Catalonia, Spain
Institut Catala d Oncologia Hospitalet. Hospital Duran i Reynals
L'Hospitalet de Llobregat, Catalonia, Spain
Complexo Hospitalario Universitario A Coruña Hospital Teresa Herrera
A Coruña, Galicia, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
National Cheng Kung University Hospital
Tainan City, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
Taoyuan District, , Taiwan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2021-004058-47
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-505456-22
Identifier Type: OTHER
Identifier Source: secondary_id
20210102
Identifier Type: -
Identifier Source: org_study_id
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