Trial record 1 of 1 for:
FORTITUDE-201
A Study of Bemarituzumab Monotherapy and Combination With Other Anti-cancer Therapy in SqNSCLC With FGFR2b Overexpression (FORTITUDE-201) (FORTITUDE-201)
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| ClinicalTrials.gov Identifier: NCT05267470 |
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Recruitment Status :
Recruiting
First Posted : March 4, 2022
Last Update Posted : January 6, 2023
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Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
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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 |
| 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
MedlinePlus Genetics related topics:
Lung cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: Part 1: Combination Dose Exploration
Participants with SqNSCLC will receive escalating doses of bemarituzumab in combination with docetaxel.
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Drug: Bemarituzumab
Intravenous (IV) infusion
Other Name: AMG 552 Drug: Docetaxel IV infusion |
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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.
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Drug: Bemarituzumab
Intravenous (IV) infusion
Other Name: AMG 552 Drug: Docetaxel IV infusion |
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Experimental: Part 3: Bemarituzumab Monotherapy
Participants with SqNSCLC and FGFR2b overexpression will receive bemarituzumab monotherapy.
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Drug: Bemarituzumab
Intravenous (IV) infusion
Other Name: AMG 552 |
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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.
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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 :
- 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) ]
- 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 :
- 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) ]
- 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) ]
- 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) ]
- Parts 1, 2, 3 and 4: Objective Response Rate [ Time Frame: Up to approximately 2 years ]
- Parts 1, 2, 3 and 4: Duration of Response [ Time Frame: Up to approximately 2 years ]
- Parts 1, 2, 3 and 4: Disease Control Rate [ Time Frame: Up to approximately 2 years ]
- Parts 1, 2, 3 and 4: Progression Free Survival [ Time Frame: Up to approximately 2 years ]
- Parts 1, 2, 3 and 4: Overall Survival [ Time Frame: Up to approximately 2 years ]
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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
| Contact: Amgen Call Center | 866-572-6436 | medinfo@amgen.com |
Locations
Show 33 study locations
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
Additional Information:
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Amgen:
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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 |