Lung Cancer Clinical Trial

A Study of Bemarituzumab Monotherapy and Docetaxel Combination in Participants With Squamous Non-small-cell Lung Cancer (SqNSCLC) With Fibroblast Growth Factor Receptor Isoform 2b (FGFR2b) Overexpression

Summary

The primary objectives of this study are to evaluate the safety and tolerability of bemarituzumab monotherapy and in combination with docetaxel, and to determine the recommended Phase 3 dose of bemarituzumab monotherapy and in combination with docetaxel.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participant has provided informed consent/assent prior to initiation of any study specific activities/procedures
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
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 and 3 only: FGFR2b overexpression as determined by centrally performed immunohistochemistry (IHC) testing

Exclusion Criteria:

Mixed small-cell lung cancer or mixed non-small cell lung cancer (NSCLC) histology
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

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

108

Study ID:

NCT05267470

Recruitment Status:

Recruiting

Sponsor:

Amgen

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There are 33 Locations for this study

See Locations Near You

University of California at Irvine Medical Center
Orange California, 92868, United States
Morristown Medical Center
Morristown New Jersey, 07960, United States
Montefiore Einstein Center for Cancer Care
Bronx New York, 10461, United States
Cliniques Universitaires Saint Luc
Bruxelles , 1200, Belgium
Universitair Ziekenhuis Antwerpen
Edegem , 2650, Belgium
Universitair Ziekenhuis Gent
Gent , 9000, Belgium
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt , 3500, Belgium
Institut Bergonie
Bordeaux , 33076, France
CHU de Lyon - Hopital Louis Pradel
Bron Cedex , 69677, France
Hôpital Tenon
Paris Cedex 20 , 75020, France
Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie
Poitiers , 86021, France
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
Rennes , 35033, France
Institut Gustave Roussy
Villejuif , 94805, France
National Cancer Center Hospital East
Kashiwa-shi Chiba, 277-8, Japan
Shizuoka Cancer Center
Sunto-gun Shizuoka, 411-8, Japan
Wakayama Medical University Hospital
Wakayama-shi Wakayama, 641-8, Japan
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do , 13620, Korea, Republic of
Severance Hospital Yonsei University Health System
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Przychodnia Lekarska Komed Roman Karaszewski
Konin , 62-50, Poland
Pratia MCM Krakow
Krakow , 30-51, Poland
Instytut Centrum Zdrowia Matki Polki
Lodz , 93-33, Poland
Instytut Genetyki i Immunologii GENIM Spzoo
Lublin , 20-60, Poland
Mazowieckie Centrum Leczenia
Otwock , 05-40, Poland
Hospital Universitario Virgen del Rocio
Sevilla Andalucía, 41013, Spain
Hospital Universitari Vall d Hebron
Barcelona Cataluña, 08035, Spain
Instituto Catalan de Oncologia Hospital Duran i Reynals
Hospitalet de Llobregat Cataluña, 08908, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda Madrid, 28222, Spain
Hospital Universitario Ramon y Cajal
Madrid , 28034, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
National Cheng Kung University Hospital
Tainan , 70403, Taiwan
Taipei Veterans General Hospital
Taipei , 11217, Taiwan
Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
Taoyuan , 33305, Taiwan

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

108

Study ID:

NCT05267470

Recruitment Status:

Recruiting

Sponsor:


Amgen

How clear is this clinincal trial information?

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