A Phase 1 interventional study of Bemarituzumab and Docetaxel in Squamous-Cell Non-Small-Cell Lung Cancer, sponsored by Amgen. Terminated at 39 sites in 8 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-03-25.
Sponsored by Amgen · Phase 1, Interventional, and Treatment
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 74 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.
Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants with SqNSCLC will receive escalating doses of bemarituzumab in combination with docetaxel.
Drug: Bemarituzumab · Drug: Docetaxel
Participants with SqNSCLC and FGFR2b overexpression will receive the dose of bemarituzumab in combination with docetaxel identified as safe during Part 1.
Drug: Bemarituzumab · Drug: Docetaxel
Participants with SqNSCLC and FGFR2b overexpression will receive bemarituzumab monotherapy.
Drug: Bemarituzumab
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 · Drug: Pembrolizumab · Drug: Carboplatin · Drug: Paclitaxel · Drug: Nab-paclitaxel
Intravenous (IV) infusion
Also known as: AMG 552
IV infusion
IV infusion
IV infusion
IV infusion
IV infusion
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.
Time frame: 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.
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.
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.
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
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.
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
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.
Time frame: 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.
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)
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).
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)
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.
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)
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.
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)
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.
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
A total of 74 participants were enrolled across 8 countries from March 2022 and the last participant last visit was in May 2024.
| Milestone | Part 1: Bemarituzumab Dose 1 With Docetaxel | Part 1: Bemarituzumab Dose 2 With Docetaxel | Part 2: Bemarituzumab Dose 2 With Docetaxel | Part 3: Bemarituzumab Dose 1 | Part 4: Bemarituzumab Dose 2 First-line Combination Therapy |
|---|---|---|---|---|---|
| Started | 4 | 9 | 29 | 28 | 4 |
| Completed | 0 | 0 | 0 | 0 | 0 |
| Not completed | 4 | 9 | 29 | 28 | 4 |
| Withdrew: Decision by sponsor | 0 | 3 | 19 | 7 | 3 |
| Withdrew: Withdrawal by subject | 1 | 1 | 2 | 2 | 0 |
| Withdrew: Death | 3 | 5 | 8 | 18 | 1 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 1 | 0 |
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.
| Participants | Part 1: Bemarituzumab Dose 1 With Docetaxel | Part 1: Bemarituzumab Dose 2 With Docetaxel | Part 4: Bemarituzumab Dose 2 First-line Combination Therapy |
|---|---|---|---|
| Number of Participants Who Experienced a Dose Limiting Toxicity (DLT): Parts 1 and 4 | 0 | 1 | 0 |
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.
| Participants | Part 1: Bemarituzumab Dose 1 With Docetaxel | Part 1: Bemarituzumab Dose 2 With Docetaxel | Part 2: Bemarituzumab Dose 2 With Docetaxel | Part 3: Bemarituzumab Dose 1 | Part 4: Bemarituzumab Dose 2 First-line Combination Therapy |
|---|---|---|---|---|---|
| Any TEAE | 4 | 9 | 29 | 25 | 4 |
| Any SAE | 4 | 5 | 16 | 8 | 4 |
| Any treatment-related TEAE | 3 | 9 | 21 | 16 | 2 |
| Any treatment-related SAE | 0 | 0 | 2 | 0 | 2 |
| Any AESI | 2 | 6 | 17 | 9 | 2 |
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.
| day*mcg/mL | Part 1: Bemarituzumab Dose 1 With Docetaxel | Part 1: Bemarituzumab Dose 2 With Docetaxel | Part 2: Bemarituzumab Dose 2 With Docetaxel | Part 3: Bemarituzumab Dose 1 | Part 4: Bemarituzumab Dose 2 First-line Combination Therapy |
|---|---|---|---|---|---|
| Cycle 1 | 3370 (2400 to 4880) | 5300 (3830 to 6870) | 3920 (2290 to 6470) | 2800 (1360 to 4820) | 3020 (2000 to 3270) |
| Cycle 2 | 2610 (2160 to 4810) | 4850 (1190 to 7290) | 4000 (1200 to 10300) | 3580 (1880 to 5970) | 2340 (1470 to 3200) |
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.
| mcg/mL | Part 1: Bemarituzumab Dose 1 With Docetaxel | Part 1: Bemarituzumab Dose 2 With Docetaxel | Part 2: Bemarituzumab Dose 2 With Docetaxel | Part 3: Bemarituzumab Dose 1 | Part 4: Bemarituzumab Dose 2 First-line Combination Therapy |
|---|---|---|---|---|---|
| Cycle 1 | 599 (457 to 751) | 746 (627 to 896) | 646 (338 to 956) | 398 (238 to 1430) | 561 (463 to 564) |
| Cycle 2 | 379 (358 to 599) | 715 (595 to 910) | 601 (314 to 845) | 532 (314 to 811) | 322 (235 to 409) |
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.
| mcg/mL | Part 1: Bemarituzumab Dose 1 With Docetaxel | Part 1: Bemarituzumab Dose 2 With Docetaxel | Part 2: Bemarituzumab Dose 2 With Docetaxel | Part 3: Bemarituzumab Dose 1 | Part 4: Bemarituzumab Dose 2 First-line Combination Therapy |
|---|---|---|---|---|---|
| Pre-dose Cycle 2 Day 1 | 51.5 (25.8 to 96.6) | 93.7 (40.2 to 175) | 88.9 (50.5 to 154) | 147 (10.1 to 554) | 29.9 (25.3 to 32.5) |
| Pre-dose Cycle 3 Day 1 | 79.1 (33.9 to 112) | 149 (45.0 to 201) | 111 (30.6 to 169) | 140 (29.3 to 271) | 69.2 (69.2 to 69.2) |
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.
| percentage of participants | Part 1: Bemarituzumab Dose 1 With Docetaxel | Part 1: Bemarituzumab Dose 2 With Docetaxel | Part 2: Bemarituzumab Dose 2 With Docetaxel | Part 3: Bemarituzumab Dose 1 | Part 4: Bemarituzumab Dose 2 First-line Combination Therapy |
|---|---|---|---|---|---|
| Percentage of Participants Who Achieved an Objective Response (OR) | 0.0 (0.0 to 60.2) | 22.2 (2.8 to 60.0) | 10.3 (2.2 to 27.4) | 0.0 (0.0 to 12.3) | 25.0 (0.6 to 80.6) |
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).
| months | Part 1: Bemarituzumab Dose 1 With Docetaxel | Part 1: Bemarituzumab Dose 2 With Docetaxel | Part 2: Bemarituzumab Dose 2 With Docetaxel | Part 3: Bemarituzumab Dose 1 | Part 4: Bemarituzumab Dose 2 First-line Combination Therapy |
|---|---|---|---|---|---|
| Duration of Response (DOR) | — | 5.5 (2.8 to NA) | 2.8 (2.8 to NA) | — | 4.5 (NA to NA) |
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.
| percentage of participants | Part 1: Bemarituzumab Dose 1 With Docetaxel | Part 1: Bemarituzumab Dose 2 With Docetaxel | Part 2: Bemarituzumab Dose 2 With Docetaxel | Part 3: Bemarituzumab Dose 1 | Part 4: Bemarituzumab Dose 2 First-line Combination Therapy |
|---|---|---|---|---|---|
| Disease Control Rate (DCR) | 75.0 (19.4 to 99.4) | 66.7 (29.9 to 92.5) | 65.5 (45.7 to 82.1) | 53.6 (33.9 to 72.5) | 75.0 (19.4 to 99.4) |
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.
| months | Part 1: Bemarituzumab Dose 1 With Docetaxel | Part 1: Bemarituzumab Dose 2 With Docetaxel | Part 2: Bemarituzumab Dose 2 With Docetaxel | Part 3: Bemarituzumab Dose 1 | Part 4: Bemarituzumab Dose 2 First-line Combination Therapy |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) | 4.2 (1.2 to NA) | 4.2 (1.4 to 10.8) | 4.0 (1.4 to 4.4) | 1.8 (1.3 to 2.6) | 5.6 (1.3 to NA) |
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.
| months | Part 1: Bemarituzumab Dose 1 With Docetaxel | Part 1: Bemarituzumab Dose 2 With Docetaxel | Part 2: Bemarituzumab Dose 2 With Docetaxel | Part 3: Bemarituzumab Dose 1 | Part 4: Bemarituzumab Dose 2 First-line Combination Therapy |
|---|---|---|---|---|---|
| Overall Survival (OS) | 6.0 (5.6 to NA) | 12.8 (3.3 to NA) | NA (9.1 to NA) | 5.4 (2.8 to 8.0) | NA (3.5 to NA) |
Collected over For all cause mortality, from first dose of bemarituzumab until end of study; median (min, max) time on study was 20.79 [1.9, 83.7] weeks. For serious AEs and other AEs, 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part 1: Bemarituzumab Dose 1 With Docetaxel | 3/4 (75%) | 4/4 (100%) | 4/4 (100%) |
| Part 1: Bemarituzumab Dose 2 With Docetaxel | 5/9 (55.6%) | 5/9 (55.6%) | 9/9 (100%) |
| Part 2: Bemarituzumab Dose 2 With Docetaxel | 8/29 (27.6%) | 16/29 (55.2%) | 26/29 (89.7%) |
| Part 3: Bemarituzumab Dose 1 | 18/28 (64.3%) | 8/28 (28.6%) | 23/28 (82.1%) |
| Part 4: Bemarituzumab Dose 2 First-line Combination Therapy | 1/4 (25%) | 4/4 (100%) | 4/4 (100%) |
| Event | Part 1: Bemarituzumab Dose 1 With Docetaxel | Part 1: Bemarituzumab Dose 2 With Docetaxel | Part 2: Bemarituzumab Dose 2 With Docetaxel | Part 3: Bemarituzumab Dose 1 | Part 4: Bemarituzumab Dose 2 First-line Combination Therapy |
|---|---|---|---|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 1/4 | 1/9 | 4/29 | 0/28 | 0/4 |
| Cardiac tamponadeCardiac disorders | 1/4 | 0/9 | 0/29 | 1/28 | 0/4 |
| Pericarditis malignantCardiac disorders | 1/4 | 0/9 | 0/29 | 0/28 | 0/4 |
| Inappropriate antidiuretic hormone secretionEndocrine disorders | 0/4 | 0/9 | 0/29 | 0/28 | 1/4 |
| Corneal epithelium defectEye disorders | 0/4 | 0/9 | 0/29 | 0/28 | 1/4 |
| AstheniaGeneral disorders | 0/4 | 0/9 | 0/29 | 0/28 | 1/4 |
| General physical health deteriorationGeneral disorders | 1/4 | 0/9 | 0/29 | 0/28 | 0/4 |
| CholecystitisHepatobiliary disorders | 1/4 | 0/9 | 0/29 | 0/28 | 0/4 |
| COVID-19Infections and infestations | 1/4 | 0/9 | 1/29 | 0/28 | 0/4 |
| SepsisInfections and infestations | 1/4 | 0/9 | 0/29 | 0/28 | 0/4 |
| Event | Part 1: Bemarituzumab Dose 1 With Docetaxel | Part 1: Bemarituzumab Dose 2 With Docetaxel | Part 2: Bemarituzumab Dose 2 With Docetaxel | Part 3: Bemarituzumab Dose 1 | Part 4: Bemarituzumab Dose 2 First-line Combination Therapy |
|---|---|---|---|---|---|
| Visual acuity reducedEye disorders | 3/4 | 6/9 | 15/29 | 9/28 | 2/4 |
| AnaemiaBlood and lymphatic system disorders | 2/4 | 1/9 | 6/29 | 1/28 | 0/4 |
| NeutropeniaBlood and lymphatic system disorders | 2/4 | 1/9 | 5/29 | 0/28 | 1/4 |
| DiarrhoeaGastrointestinal disorders | 2/4 | 2/9 | 8/29 | 0/28 | 0/4 |
| DysgeusiaNervous system disorders | 2/4 | 0/9 | 1/29 | 1/28 | 1/4 |
| KeratopathyEye disorders | 1/4 | 2/9 | 10/29 | 4/28 | 0/4 |
| AstheniaGeneral disorders | 1/4 | 1/9 | 10/29 | 2/28 | 1/4 |
| Corneal disorderEye disorders | 1/4 | 3/9 | 2/29 | 2/28 | 1/4 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/4 | 3/9 | 3/29 | 3/28 | 1/4 |
| Decreased appetiteMetabolism and nutrition disorders | 1/4 | 2/9 | 8/29 | 4/28 | 0/4 |
| Age, Continuous(years) | Part 1: Bemarituzumab Dose 1 With Docetaxel | Part 1: Bemarituzumab Dose 2 With Docetaxel | Part 2: Bemarituzumab Dose 2 With Docetaxel | Part 3: Bemarituzumab Dose 1 | Part 4: Bemarituzumab Dose 2 First-line Combination Therapy | Total |
|---|---|---|---|---|---|---|
| Mean | 64.0 ± 4.5 | 65.9 ± 8.5 | 65.3 ± 6.2 | 63.0 ± 8.2 | 63.0 ± 7.9 | 64.3 ± 7.2 |
| Sex: Female, Male(Participants) | Part 1: Bemarituzumab Dose 1 With Docetaxel | Part 1: Bemarituzumab Dose 2 With Docetaxel | Part 2: Bemarituzumab Dose 2 With Docetaxel | Part 3: Bemarituzumab Dose 1 | Part 4: Bemarituzumab Dose 2 First-line Combination Therapy | Total |
|---|---|---|---|---|---|---|
| Female | 0 | 2 | 2 | 8 | 0 | 12 |
| Male | 4 | 7 | 27 | 20 | 4 | 62 |
| Ethnicity (NIH/OMB)(Participants) | Part 1: Bemarituzumab Dose 1 With Docetaxel | Part 1: Bemarituzumab Dose 2 With Docetaxel | Part 2: Bemarituzumab Dose 2 With Docetaxel | Part 3: Bemarituzumab Dose 1 | Part 4: Bemarituzumab Dose 2 First-line Combination Therapy | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 2 | 0 | 0 | 2 |
| Not Hispanic or Latino | 4 | 9 | 27 | 27 | 4 | 71 |
| Unknown or Not Reported | 0 | 0 | 0 | 1 | 0 | 1 |
| Race/Ethnicity, Customized(Participants) | Part 1: Bemarituzumab Dose 1 With Docetaxel | Part 1: Bemarituzumab Dose 2 With Docetaxel | Part 2: Bemarituzumab Dose 2 With Docetaxel | Part 3: Bemarituzumab Dose 1 | Part 4: Bemarituzumab Dose 2 First-line Combination Therapy | Total |
|---|---|---|---|---|---|---|
| Asian | 2 | 4 | 12 | 12 | 3 | 33 |
| Black or African American | 0 | 0 | 1 | 0 | 0 | 1 |
| White | 2 | 4 | 14 | 11 | 1 | 32 |
| Other | 0 | 0 | 1 | 0 | 0 | 1 |
| Missing | 0 | 1 | 1 | 5 | 0 | 7 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting information: Study protocol, Sap, Icf, Csr
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