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 (FORTITUDE-201)

  • STATUS
    Recruiting
  • End date
    Jul 10, 2025
  • participants needed
    108
  • sponsor
    Amgen
Updated on 17 June 2022

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.

Details
Condition Squamous-Cell Non-Small-Cell Lung Cancer
Treatment docetaxel, Bemarituzumab
Clinical Study IdentifierNCT05267470
SponsorAmgen
Last Modified on17 June 2022

Eligibility

Yes No Not Sure

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
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