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Trial record 1 of 1 for:    FORTITUDE-201
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A Study of Bemarituzumab Monotherapy and Combination With Other Anti-cancer Therapy in SqNSCLC With FGFR2b Overexpression (FORTITUDE-201) (FORTITUDE-201)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05267470
Recruitment Status : Recruiting
First Posted : March 4, 2022
Last Update Posted : January 6, 2023
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
The primary objectives of this study are to evaluate the safety and tolerability of bemarituzumab monotherapy and combination with other anti-cancer therapies, and to determine the recommended phase 3 dose of bemarituzumab in combination with other anti-cancer therapies.

Condition or disease Intervention/treatment Phase
Squamous-Cell Non-Small-Cell Lung Cancer Drug: Bemarituzumab Drug: Docetaxel Drug: Pembrolizumab Drug: Carboplatin Drug: Paclitaxel Drug: Nab-paclitaxel Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Bemarituzumab Monotherapy and Combination With Other Anti-Cancer Therapy in Subjects With Squamous-Cell Non-Small-Cell Lung Cancer (FORTITUDE-201)
Actual Study Start Date : March 29, 2022
Estimated Primary Completion Date : August 30, 2024
Estimated Study Completion Date : August 31, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Part 1: Combination Dose Exploration
Participants with SqNSCLC will receive escalating doses of bemarituzumab in combination with docetaxel.
Drug: Bemarituzumab
Intravenous (IV) infusion
Other Name: AMG 552

Drug: Docetaxel
IV infusion

Experimental: 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.
Drug: Bemarituzumab
Intravenous (IV) infusion
Other Name: AMG 552

Drug: Docetaxel
IV infusion

Experimental: Part 3: Bemarituzumab Monotherapy
Participants with SqNSCLC and FGFR2b overexpression will receive bemarituzumab monotherapy.
Drug: Bemarituzumab
Intravenous (IV) infusion
Other Name: AMG 552

Experimental: 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.
Drug: Bemarituzumab
Intravenous (IV) infusion
Other Name: AMG 552

Drug: Pembrolizumab
IV infusion

Drug: Carboplatin
IV infusion

Drug: Paclitaxel
IV infusion

Drug: Nab-paclitaxel
IV infusion




Primary Outcome Measures :
  1. Part 1 and 4: Number of Participants Who Experience a Dose Limiting Toxicity (DLT) [ Time Frame: Cycle 1 Day 1 to Cycle 1 Day 21 (cycle is 21 days) ]
  2. Parts 1, 2, 3 and 4: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE) [ Time Frame: Cycle 1 Day 1 to 28 days after last dose (approximately 5 months; cycle is 21 days in Parts 1 and 2, cycle is 14 days in Part 3) ]
    Adverse events (AEs) are defined as any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurs after the participant has received study treatment. Any clinically significant changes in vital signs, physical examinations, clinical laboratory tests, and visual acuity that occur after study treatment administration will be recorded as TEAEs.


Secondary Outcome Measures :
  1. Parts 1, 2, 3 and 4: Area Under the Concentration Time Curve (AUC) of Bemarituzumab [ Time Frame: Part 1/2/4: Day 1 cycles 1-3, Day 1 every odd numbered cycle thereafter, and 28 days after last dose (cycle=21 days). Part 3: Day 1 and 8 cycle 1, Day 1 cycles 2-3, Day 1 of every odd numbered cycle thereafter, and 28 days after last dose (cycle=14 days) ]
  2. Parts 1, 2, 3 and 4: Maximum Observed Concentration (Cmax) of Bemarituzumab [ Time Frame: Part 1/2/4: Day 1 cycles 1-3, Day 1 every odd numbered cycle thereafter, and 28 days after last dose (cycle=21 days). Part 3: Day 1 and 8 cycle 1, Day 1 cycles 2-3, Day 1 of every odd numbered cycle thereafter, and 28 days after last dose (cycle=14 days) ]
  3. Parts 1, 2, 3 and 4: Observed Concentration at the End of a Dose Interval (Ctrough) of Bemarituzumab [ Time Frame: Part 1/2/4: Day 1 cycles 1-3, Day 1 every odd numbered cycle thereafter, and 28 days after last dose (cycle=21 days). Part 3: Day 1 and 8 cycle 1, Day 1 cycles 2-3, Day 1 of every odd numbered cycle thereafter, and 28 days after last dose (cycle=14 days) ]
  4. Parts 1, 2, 3 and 4: Objective Response Rate [ Time Frame: Up to approximately 2 years ]
  5. Parts 1, 2, 3 and 4: Duration of Response [ Time Frame: Up to approximately 2 years ]
  6. Parts 1, 2, 3 and 4: Disease Control Rate [ Time Frame: Up to approximately 2 years ]
  7. Parts 1, 2, 3 and 4: Progression Free Survival [ Time Frame: Up to approximately 2 years ]
  8. Parts 1, 2, 3 and 4: Overall Survival [ Time Frame: Up to approximately 2 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • 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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05267470


Contacts
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Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
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Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT05267470    
Other Study ID Numbers: 20210102
2021-004058-47 ( EudraCT Number )
First Posted: March 4, 2022    Key Record Dates
Last Update Posted: January 6, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
URL: http://www.amgen.com/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amgen:
Squamous-Cell Non-Small-Cell Lung Cancer
FGFR2b-positive Squamous-Cell Non-Small-Cell Lung Cancer
SqNSCLC
Bemarituzumab
Docetaxel
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Docetaxel
Albumin-Bound Paclitaxel
Carboplatin
Pembrolizumab
Bemarituzumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological