Squamous-Cell Non-Small-Cell Lung Cancer Clinical Trial
— FORTITUDE-201Official 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)
| Verified date | June 2024 |
| Source | Amgen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 74 |
| Est. completion date | May 28, 2024 |
| Est. primary completion date | April 9, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 99 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Cliniques Universitaires Saint Luc | Bruxelles | |
| Belgium | Universitair Ziekenhuis Antwerpen | Edegem | |
| Belgium | Universitair Ziekenhuis Gent | Gent | |
| Belgium | Jessa Ziekenhuis - Campus Virga Jesse | Hasselt | |
| France | Institut Bergonie | Bordeaux | |
| France | CHU de Lyon - Hopital Louis Pradel | Bron Cedex | |
| France | Hôpital Tenon | Paris Cedex 20 | |
| France | Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie | Poitiers | |
| France | Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou | Rennes | |
| France | Institut Gustave Roussy | Villejuif | |
| Japan | National Cancer Center Hospital East | Kashiwa-shi | Chiba |
| Japan | Shizuoka Cancer Center | Sunto-gun | Shizuoka |
| Japan | Wakayama Medical University Hospital | Wakayama-shi | Wakayama |
| Korea, Republic of | Seoul National University Bundang Hospital | Seongnam-si, Gyeonggi-do | |
| Korea, Republic of | Asan Medical Center | Seoul | |
| Korea, Republic of | Severance Hospital Yonsei University Health System | Seoul | |
| Poland | Przychodnia Lekarska Komed Roman Karaszewski | Konin | |
| Poland | Krakowskie Centrum Medyczne Sp zoo | Krakow | |
| Poland | Pratia Mcm Krakow | Krakow | |
| Poland | Instytut Centrum Zdrowia Matki Polki | Lodz | |
| Poland | Centrum Medyczne Hope Clinic Sebastian Szklener | Lublin | |
| Poland | Instytut Genetyki i Immunologii GENIM Spzoo | Lublin | |
| Poland | Mazowieckie centrum leczenia | Otwock | |
| Spain | Complexo Hospitalario Universitario A Coruña Hospital Teresa Herrera | A Coruña | Galicia |
| Spain | Hospital Clinic i Provincial de Barcelona | Barcelona | Cataluña |
| Spain | Hospital Universitari Vall d Hebron | Barcelona | Cataluña |
| Spain | Institut Catala d Oncologia Hospitalet. Hospital Duran i Reynals | Hospitalet de Llobregat | Cataluña |
| Spain | Hospital Universitario 12 de Octubre | Madrid | |
| Spain | Hospital Universitario Ramon y Cajal | Madrid | |
| Spain | Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda | Madrid |
| Spain | Hospital Regional Universitario de Malaga | Malaga | Andalucía |
| Spain | Hospital Universitario Virgen del Rocio | Sevilla | Andalucía |
| Taiwan | National Cheng Kung University Hospital | Tainan | |
| Taiwan | Taipei Veterans General Hospital | Taipei | |
| Taiwan | Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation | Taoyuan | |
| United States | Montefiore Einstein Center for Cancer Care | Bronx | New York |
| United States | Morristown Medical Center | Morristown | New Jersey |
| United States | University of California Irvine | Orange | California |
| United States | University of Pittsburgh, Cancer Institute | Pittsburgh | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Amgen |
United States, Belgium, France, Japan, Korea, Republic of, Poland, Spain, Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Part 1 and 4: Number of Participants Who Experience a Dose Limiting Toxicity (DLT) | Cycle 1 Day 1 to Cycle 1 Day 21 (cycle is 21 days) | ||
| Primary | Parts 1, 2, 3 and 4: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE) | 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. | 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) | |
| Secondary | Parts 1, 2, 3 and 4: Area Under the Concentration Time Curve (AUC) of Bemarituzumab | 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) | ||
| Secondary | Parts 1, 2, 3 and 4: Maximum Observed Concentration (Cmax) of Bemarituzumab | 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) | ||
| Secondary | Parts 1, 2, 3 and 4: Observed Concentration at the End of a Dose Interval (Ctrough) of Bemarituzumab | 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) | ||
| Secondary | Parts 1, 2, 3 and 4: Objective Response Rate | Up to approximately 2 years | ||
| Secondary | Parts 1, 2, 3 and 4: Duration of Response | Up to approximately 2 years | ||
| Secondary | Parts 1, 2, 3 and 4: Disease Control Rate | Up to approximately 2 years | ||
| Secondary | Parts 1, 2, 3 and 4: Progression Free Survival | Up to approximately 2 years | ||
| Secondary | Parts 1, 2, 3 and 4: Overall Survival | Up to approximately 2 years |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT04171284 -
SCT-I10A or Placebo Plus Docetaxel With Previously Treated Squamous Cell Non-small Cell Lung Cancer
|
Phase 3 |