Squamous-Cell Non-Small-Cell Lung CancerPhase 1FORTITUDE-201NCT05267470
A Study of Bemarituzumab Monotherapy and Combination With Other Anti-cancer Therapy in SqNSCLC With FGFR2b Overexpression (FORTITUDE-201)
A Phase 1 study testing Bemarituzumab, Docetaxel and Pembrolizumab in people with Squamous-Cell Non-Small-Cell Lung Cancer, run by Amgen at 39 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Squamous-Cell Non-Small-Cell Lung Cancer
- What is being tested?
- Bemarituzumab, Docetaxel and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 39 sitesin 8 countries
- Study dates
- 29 Mar 2022to 28 May 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
39 sites in 8 countries.
39 sites in 8 countries
Spain9 sites
Complexo Hospitalario Universitario A Coruña Hospital Teresa Herrera
A Coruña, Galicia, 15006
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, 08035
Hospital Clinic i Provincial de Barcelona
Barcelona, Catalonia, 08036
Institut Catala d Oncologia Hospitalet. Hospital Duran i Reynals
L'Hospitalet de Llobregat, Catalonia, 08908
Hospital Universitario Ramon y Cajal
Madrid, 28034
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222
Hospital Regional Universitario de Malaga
Málaga, Andalusia, 29011
Hospital Universitario Virgen del Rocio
Seville, Andalusia, 41013
Poland7 sites
Przychodnia Lekarska Komed Roman Karaszewski
Konin, 62-500
Pratia Mcm Krakow
Krakow, 30-727
Krakowskie Centrum Medyczne Sp zoo
Krakow, 31-501
Instytut Centrum Zdrowia Matki Polki
Lodz, 93-338
Instytut Genetyki i Immunologii GENIM Spzoo
Lublin, 20-609
Centrum Medyczne Hope Clinic Sebastian Szklener
Lublin, 20-701
Mazowieckie centrum leczenia
Otwock, 05-400
France6 sites
Institut Bergonie
Bordeaux, 33076
CHU de Lyon - Hopital Louis Pradel
Bron, 69677
Hôpital Tenon
Paris, 75020
Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie
Poitiers, 86021
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
Rennes, 35033
Institut Gustave Roussy
Villejuif, 94805
United States4 sites
Morristown Medical Center
Morristown, New Jersey, 07960
University of California Irvine
Orange, California, 92868
University of Pittsburgh, Cancer Institute
Pittsburgh, Pennsylvania, 15211
Montefiore Einstein Center for Cancer Care
The Bronx, New York, 10461
Belgium4 sites
Cliniques Universitaires Saint Luc
Brussels, 1200
Universitair Ziekenhuis Antwerpen
Edegem, 2650
Universitair Ziekenhuis Gent
Ghent, 9000
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt, 3500
Japan3 sites
National Cancer Center Hospital East
Kashiwa-shi, Chiba, 277-8577
Shizuoka Cancer Center
Sunto-gun, Shizuoka, 411-8777
Wakayama Medical University Hospital
Wakayama, Wakayama, 641-8510
South Korea3 sites
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Severance Hospital Yonsei University Health System
Seoul, 03722
Asan Medical Center
Seoul, 05505
Taiwan3 sites
National Cheng Kung University Hospital
Tainan, 70403
Taipei Veterans General Hospital
Taipei, 11217
Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
Taoyuan, 33305
About this study
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)
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.
- Conditions
- Squamous-Cell Non-Small-Cell Lung Cancer
- Being tested
- Bemarituzumab, Docetaxel, Pembrolizumab, Carboplatin, Paclitaxel
- Keywords
- Squamous-Cell Non-Small-Cell Lung Cancer, FGFR2b-positive Squamous-Cell Non-Small-Cell Lung Cancer, SqNSCLC, Bemarituzumab, Docetaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BemarituzumabDrug
Also called AMG 552
Intravenous (IV) infusion
DocetaxelDrug
IV infusion
PembrolizumabDrug
IV infusion
CarboplatinDrug
IV infusion
PaclitaxelDrug
IV infusion
Nab-paclitaxelDrug
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Combination Dose Exploration | Experimental | Participants with SqNSCLC will receive escalating doses of bemarituzumab in combination with docetaxel. Receives: Drug: Bemarituzumab; Drug: Docetaxel |
| Part 2: Combination Dose Expansion | Experimental | Participants with SqNSCLC and FGFR2b overexpression will receive the dose of bemarituzumab in combination with docetaxel identified as safe during Part 1. Receives: Drug: Bemarituzumab; Drug: Docetaxel |
| Part 3: Bemarituzumab Monotherapy | Experimental | Participants with SqNSCLC and FGFR2b overexpression will receive bemarituzumab monotherapy. Receives: Drug: Bemarituzumab |
| Part 4: Combination Immuno-chemotherapy | Experimental | 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. Receives: Drug: Bemarituzumab; Drug: Pembrolizumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experienced a Dose Limiting Toxicity (DLT): Parts 1 and 4
DLTs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and included the below if considered by the investigator to be related to study drug, excluding toxicities related to disease progression or intercurrent illness: Grade 3 thrombocytopenia for > 7 days or with Grade > 2 bleeding, vomiting/diarrhea for > 3 days, fatigue; Grade ≥ 3 febrile neutropenia, nausea for > 3 days; Grade 4 neutropenia, thrombocytopenia, anemia, ophthalmologic AE, laboratory value, vomiting/diarrhea; Grade 5 toxicity (death not due to disease progression). CTCAE Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, and Grade 5 results in death.
Measured: Day 1 to Day 21 of Cycle 1 (each cycle was 21 days)
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An AE was defined as any untoward medical occurrence in a clinical trial participants. TEAEs were any AE that started on or after receiving the first dose of investigational product and up to 28 days after the last dose of investigational product or the end of study date, whichever is earlier. Treatment-related TEAEs were those considered possibly related to study treatment by the investigator. Any clinically significant changes in electrocardiograms, vital signs, physical examination with a neurological assessment, clinical laboratory tests, and visual acuity were recorded as TEAEs. A serious TEAE resulted in death, was immediately life threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event. AEs of special interest (AESIs) were ocular events of any CTCAE grade or seriousness occurring up to 100 days after the last dose of bemarituzumab.
Measured: Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
Secondary outcomes (8)
Area Under the Serum Drug Concentration-time Curve From Time 0 to End of Dosing Interval (AUCtau) of Bemarituzumab
Bemarituzumab serum concentrations with values below the limit of quantification were set to zero for analysis. Pharmacokinetic (PK) parameters were determined from the time concentration profile using noncompartmental analysis.
Measured: Parts 1, 2, 3, and 4: Cycles 1 and 2 pre-dose, 0.25, 3, 6, 24, 72, 168, 336, 504 (except Part 3) hours post-dose
Maximum Observed Serum Concentration (Cmax) of Bemarituzumab
Bemarituzumab serum concentrations with values below the limit of quantification were set to zero for analysis. PK parameters were determined from the time concentration profile using noncompartmental analysis.
Measured: Parts 1, 2, 3, and 4: Cycles 1 and 2 pre-dose, 0.25, 3, 6, 24, 72, 168, 336, 504 (except Part 3) hours post-dose
Observed Concentration at the End of a Dose Interval (Ctrough) of Bemarituzumab
Bemarituzumab serum concentrations with values below the limit of quantification were set to zero for analysis. PK parameters were determined from the time concentration profile using noncompartmental analysis.
Measured: Pre-dose Cycle 2 Day 1 and Cycle 3 day 1
Percentage of Participants Who Achieved an Objective Response (OR)
OR was defined as the best overall response of confirmed complete response (CR) or confirmed partial response (PR) as defined by the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to <10 mm. All lymph nodes must have been non-pathological in size (< 10 mm).
PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: Every 6 (+/- 1) weeks from the first dose of bemarituzumab (cycle 1 day 1) up to week 54, then every 12 (+/- 2 weeks), up to the end of the long term follow-up (LTFU) period (median time on study was approximately 21 weeks)
Duration of Response (DOR)
DOR was defined as the time from the first documentation of OR (determined by the investigator per RECIST v1.1) until first documentation of disease progression or death due to any cause, whichever occurred first.
DOR was censored at the last evaluable post-baseline tumor assessment prior to subsequent anticancer therapy; otherwise, at date of first documentation of OR (i.e., assigned a one-day interval).
Measured: Every 6 (+/- 1) weeks from the first dose of bemarituzumab (cycle 1 day 1) up to week 54, then every 12 (+/- 2 weeks), up to the end of the LTFU period (median time on study was approximately 21 weeks)
Disease Control Rate (DCR)
DCR was defined as the percentage of participants documented to have a CR, PR or stable disease (SD) per RECIST v1.1.
CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to <10 mm. All lymph nodes must have been non-pathological in size (< 10 mm).
PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).
PD: at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an increase of at least 5 mm. Unequivocal progression of existing non-target lesions.
Measured: Every 6 (+/- 1) weeks from the first dose of bemarituzumab (cycle 1 day 1) up to week 54, then every 12 (+/- 2 weeks), up to the end of the LTFU period (median time on study was approximately 21 weeks)
Progression-free Survival (PFS)
PFS was defined as the time from date of first dose of investigational product until the first documentation of radiologic disease progression or death due to any cause, whichever occurred first, in the absence of subsequent anticancer therapy.
PFS was censored at the last evaluable post-baseline tumor assessment prior to subsequent anticancer therapy; otherwise, at first dose of investigational product. Progression was based on RECIST v1.1 criteria.
PD: at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an increase of at least 5 mm. Unequivocal progression of existing non-target lesions.
Measured: Participants completed the LTFU for survival every 3 months ± 1 month after the safety follow-up visit (at 28 days after the last dose of bemarituzumab), up to the end of the study. Median time on study was approximately 21 weeks
Overall Survival (OS)
OS was defined as the time from the date of first dose of investigational product until event of death due to any cause through the analysis cutoff date. Participants still alive were censored at the date last known to be alive through the analysis cutoff date.
Measured: Participants completed the LTFU for survival every 3 months ± 1 month after the safety follow-up visit (at 28 days after the last dose of bemarituzumab), up to the end of the study. Median time on study was approximately 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start29 Mar 2022
- Primary completion28 May 2024
- Study completion28 May 2024
Why it stopped: Business decision not due to safety concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Squamous-Cell Non-Small-Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05267470
- Sponsor's protocol ID
- 20210102
- Other IDs
- 2021-004058-47, 2023-505456-22, 2023
- Acronym
- FORTITUDE-201
- Status last verified
- Feb 2025
- First submitted
- 24 Feb 2022
- Last updated
- 25 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05267470
- Acronym / sponsor ID
- FORTITUDE-201 / 20210102
- Conditions
- Squamous-Cell Non-Small-Cell Lung Cancer
- Keywords
- Squamous-Cell Non-Small-Cell Lung Cancer, FGFR2b-positive Squamous-Cell Non-Small-Cell Lung Cancer, SqNSCLC, Bemarituzumab, Docetaxel
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision not due to safety concerns
- Enrolment
- 74 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2022 (actual)
- Primary completion
- 28 May 2024 (actual)
- Study completion
- 28 May 2024 (actual)
- First posted
- 4 Mar 2022 (actual)
- Results
- Posted 25 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1: Combination Dose Exploration | Experimental | Drug: Bemarituzumab, Drug: DocetaxelParticipants with SqNSCLC will receive escalating doses of bemarituzumab in combination with docetaxel. |
| Part 2: Combination Dose Expansion | Experimental | Drug: Bemarituzumab, Drug: DocetaxelParticipants with SqNSCLC and FGFR2b overexpression will receive the dose of bemarituzumab in combination with docetaxel identified as safe during Part 1. |
| Part 3: Bemarituzumab Monotherapy | Experimental | Drug: BemarituzumabParticipants with SqNSCLC and FGFR2b overexpression will receive bemarituzumab monotherapy. |
| Part 4: Combination Immuno-chemotherapy | Experimental | Drug: Bemarituzumab, Drug: Pembrolizumab, Drug: Carboplatin, Drug: Paclitaxel, Drug: Nab-paclitaxelParticipants 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BemarituzumabAlso: AMG 552Intravenous (IV) infusion | Drug | Part 1: Combination Dose Exploration, Part 2: Combination Dose Expansion, Part 3: Bemarituzumab Monotherapy, Part 4: Combination Immuno-chemotherapy |
| DocetaxelIV infusion | Drug | Part 1: Combination Dose Exploration, Part 2: Combination Dose Expansion |
| PembrolizumabIV infusion | Drug | Part 4: Combination Immuno-chemotherapy |
| CarboplatinIV infusion | Drug | Part 4: Combination Immuno-chemotherapy |
| PaclitaxelIV infusion | Drug | Part 4: Combination Immuno-chemotherapy |
| Nab-paclitaxelIV infusion | Drug | Part 4: Combination Immuno-chemotherapy |
Primary outcome
Number of Participants Who Experienced a Dose Limiting Toxicity (DLT): Parts 1 and 4
Time frame: Day 1 to Day 21 of Cycle 1 (each cycle was 21 days)
DLTs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and included the below if considered by the investigator to be related to study drug, excluding toxicities related to disease progression or intercurrent illness: Grade 3 thrombocytopenia for > 7 days or with Grade > 2 bleeding, vomiting/diarrhea for > 3 days, fatigue; Grade ≥ 3 febrile neutropenia, nausea for > 3 days; Grade 4 neutropenia, thrombocytopenia, anemia, ophthalmologic AE, laboratory value, vomiting/diarrhea; Grade 5 toxicity (death not due to disease progression). CTCAE Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, and Grade 5 results in death.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1 of cycle 1 to 100 days after the last dose of study treatment or end of study date, whichever occurred earlier (Parts 1, 2, and 4 cycle length = 21 days; Part 3 cycle length = 14 days). Median treatment duration was 6.2 weeks.
An AE was defined as any untoward medical occurrence in a clinical trial participants. TEAEs were any AE that started on or after receiving the first dose of investigational product and up to 28 days after the last dose of investigational product or the end of study date, whichever is earlier. Treatment-related TEAEs were those considered possibly related to study treatment by the investigator. Any clinically significant changes in electrocardiograms, vital signs, physical examination with a neurological assessment, clinical laboratory tests, and visual acuity were recorded as TEAEs. A serious TEAE resulted in death, was immediately life threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event. AEs of special interest (AESIs) were ocular events of any CTCAE grade or seriousness occurring up to 100 days after the last dose of bemarituzumab.
8 secondary outcomes
Area Under the Serum Drug Concentration-time Curve From Time 0 to End of Dosing Interval (AUCtau) of Bemarituzumab
Time frame: Parts 1, 2, 3, and 4: Cycles 1 and 2 pre-dose, 0.25, 3, 6, 24, 72, 168, 336, 504 (except Part 3) hours post-dose
Maximum Observed Serum Concentration (Cmax) of Bemarituzumab
Time frame: Parts 1, 2, 3, and 4: Cycles 1 and 2 pre-dose, 0.25, 3, 6, 24, 72, 168, 336, 504 (except Part 3) hours post-dose
Observed Concentration at the End of a Dose Interval (Ctrough) of Bemarituzumab
Time frame: Pre-dose Cycle 2 Day 1 and Cycle 3 day 1
Percentage of Participants Who Achieved an Objective Response (OR)
Time frame: Every 6 (+/- 1) weeks from the first dose of bemarituzumab (cycle 1 day 1) up to week 54, then every 12 (+/- 2 weeks), up to the end of the long term follow-up (LTFU) period (median time on study was approximately 21 weeks)
Duration of Response (DOR)
Time frame: Every 6 (+/- 1) weeks from the first dose of bemarituzumab (cycle 1 day 1) up to week 54, then every 12 (+/- 2 weeks), up to the end of the LTFU period (median time on study was approximately 21 weeks)
Disease Control Rate (DCR)
Time frame: Every 6 (+/- 1) weeks from the first dose of bemarituzumab (cycle 1 day 1) up to week 54, then every 12 (+/- 2 weeks), up to the end of the LTFU period (median time on study was approximately 21 weeks)
Progression-free Survival (PFS)
Time frame: Participants completed the LTFU for survival every 3 months ± 1 month after the safety follow-up visit (at 28 days after the last dose of bemarituzumab), up to the end of the study. Median time on study was approximately 21 weeks
Overall Survival (OS)
Time frame: Participants completed the LTFU for survival every 3 months ± 1 month after the safety follow-up visit (at 28 days after the last dose of bemarituzumab), up to the end of the study. Median time on study was approximately 21 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Related trials for Squamous-Cell Non-Small-Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Not yet recruitingPhase 2
Phase II Study to Evaluate Telisotuzumab Adizutecan in Combination With RC148(ABBV-1480) as First-Line Treatment for Patients With Non-Squamous Non-Small-Cell Lung Cancer
Patients With Locally Advanced or Metastatic Non-Squamous NSCLC Requiring First-Line Treatment and no Driver Gene Alterations Confirmed by Histology or Cytology
Active, not recruitingPhase 2
Carboplatin, Taxane And Ramucirumab for Patients With NSCLC After Pemetrexed or Pembrolizumab Maintenance
Non-small Cell Lung Cancer
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
39 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bemarituzumab, Docetaxel and Pembrolizumab in people with Squamous-Cell Non-Small-Cell Lung Cancer, run by Amgen at 39 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Spain, Poland, France, United States, Belgium and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experienced a Dose Limiting Toxicity (DLT): Parts 1 and 4 (time frame: Day 1 to Day 21 of Cycle 1 (each cycle was 21 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.