do_not_disturb_altRecruitment Complete

Advanced non-small cell lung cancer, EGFR mutation, HER2 mutation

First in human study of BAY2927088 in participants who have advanced non-small cell lung cancer (NSCLC) with mutations in the genes of epidermal growth factor receptor (EGFR) and/or human epidermal growth factor receptor 2 (HER2)

Trial purpose

Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC), a group of lung cancers that have spread to nearby tissues or to other parts of the body.

Epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) are proteins that help cells to grow and divide. A damage (also called mutation) to the building plans (genes) for these proteins in cancer cells leads to a production of abnormal EGFR and/or HER2. These abnormal proteins drive the growth and the spread of the cancer. Several EGFR and/or HER2 mutations exist in the cancer cells. The study treatment, BAY2927088, is expected to block the mutated EGFR and HER2 proteins which may stop the spread of NSCLC.

The main purpose of this study is to learn:
Escalation, Backfill, and Expansion Part:
• How safe is BAY2927088 for the participants?
• What is the highest dose of BAY2927088 that can be tolerated (maximum tolerated dose) by or given to (maximum administered dose) the participants?
• How does BAY2927088 move into, through, and out of the bodies of the participants?
For this, the researchers will measure the followings:
• The number of participants with medical problems, also called adverse events and serious adverse events, and their severity
• The number of participants who discontinue study treatment due to an adverse event.
• The highest dose of BAY2927088 that the participants can take without having adverse events (maximum tolerated dose (MTD)) or the maximum dose that is tested and found to be safe for the participants in case MTD cannot be found out (maximum administered dose (MAD)) of BAY2927088
• Number of participants experiencing adverse events that prevent an increase in the dose of BAY2927088 (dose-limiting toxicities (DLTs)) at each dose level
• The (average) total level of BAY2927088 in the blood (also called AUC) after receiving single or multiple doses of BAY2927088
• The (average) highest level of BAY2927088 in the blood (also called Cmax) after receiving a single or multiple doses of BAY2927088
Extension Part
• How well does BAY2927088 work in participants?
For this, the researchers will measure the following:
• Percentage of participants whose cancer completely disappears (complete response) or reduces by at least 30% (partial response) after taking the treatment (also known as objective response rate (ORR)). This will be assessed by doctors other than the study doctor.

This study has 4 parts:
• The escalation part aims to find the maximum daily amount (dose) of BAY2927088 that participants can receive.
• The backfill part aims to test the doses of BAY2927088 that are considered safe in the escalation part by giving it to more participants. This will help find optimal doses of BAY2927088 that work well and are safe to be tested in the next part.
• The expansion part aims to determine the dose of BAY2927088 to be tested in further studies.
• The extension part aims to determine whether the selected dose of BAY2927088 from the expansion part works well.

The participants in this study will take the study treatment BAY2927088 in 3-week periods called “cycles”. They will in general take BAY2927088 once or twice daily as a liquid/tablet by mouth until their cancer gets worse, they have medical problems, they leave the study, or the study is terminated. Participants will have no more than 5 visits per cycle.

During the study, the study team will:
• take blood and urine samples,
• check the status of the cancer by doing computed tomography (CT) or magnetic resonance imaging (MRI) scans,
• check the participants’ overall health and heart health,
• ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is considered “serious” when it leads to death, puts the participant’s life at risk, requires hospitalization, causes disability, causes a baby being born with medical problems, or is medically important.

Key Participants Requirements

Sex

All

Age

18 - N/A

  • - Documented histologically or cytologically confirmed locally advanced NSCLC, not suitable for definitive therapy or recurrent or metastatic NSCLC at screening (small cell or mixed histologies are excluded).
    - Documented disease progression after treatment with at least one prior systemic therapy for advanced disease. Participants who do not have standard of care access due to any reason, are intolerant to, or are not eligible for standard treatments, may also be eligible.
    Note: Except for participants eligible for one of the groups (Expansion or Extension) who should have received no prior systemic treatment for locally advanced or metastatic disease.
    - Adequate archival tumor tissue (ideally taken after last targeted treatment and not older than 6 months) has to be available, either from primary or metastatic sites. If archival material is not available, a fresh tumor biopsy should be performed if feasible and if the procedure poses no significant risk for the participant.
    - Measurable disease by RECIST v1.1 with at least one lesion not chosen for biopsy during the screening period (if a biopsy is taken during screening) that can be accurately measured at baseline with computed tomography (CT) or magnetic resonance imaging (MRI) and that is suitable for accurate repeated measurements. A biopsied lesion should not be used as a target lesion for RECIST 1.1 tumor assessments (or, for participants in Expansion Group G, for RANO-BM tumor assessments). Previously irradiated lesions must have shown progression to be considered measurable.
    - Documented activating EGFR and/or HER2 mutation assessed by a Clinical Laboratory Improvement Amendments (CLIA)-certified (United States [US] sites) or an equally accredited (outside of the US) local laboratory
    - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
    - Minimum life expectancy of 12 weeks.
    - Adequate bone marrow function as assessed by the following laboratory tests to be conducted within 7 days before the first dose of study treatment:
    a. Hemoglobin ≥ 9.0 g/dL. Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within 2 weeks prior to testing.
    b. Platelets ≥ 100 × 10^9 cells/L.
    c. Absolute neutrophil count ≥ 1.5 ×10^9 cells/L. Criteria must be met without the use of hematopoietic growth factors (e.g., G-CSF) within 2 weeks prior to testing.
    - Adequate kidney function as assessed by following laboratory test to be conducted within 7 days before the first dose of study treatment:
    a. Estimated glomerular filtration rate (eGFR) > 50 mL/min per 1.73 m^2 according to the Modification of Diet in renal Disease Study Group (MDRD) formula.
    - Adequate liver function as assessed by following laboratory tests to be conducted within 7 days before the first dose of study treatment:
    a. Total bilirubin ≤ 1.5 × ULN (or ≤ 3 X ULN for participants with documented Gilbert-Meulengracht Syndrome, or for participants with hyperbilirubinemia considered due to liver metastasis).
    b. Aspartate transaminase and alanine transaminase ≤ 2.5 × ULN (or ≤ 5 × ULN if due to liver involvement by tumor).

  • - Treatment with an EGFR tyrosine kinase inhibitor (TKI) ≤ 8 days or 5x the terminal phase, elimination half-lives, whichever is shorter, prior to the first dose of study drug.
    - Treatment with a systemic anti-cancer treatment (excluding EGFR TKIs as described above) ≤ 14 days prior to the first dose of study drug.
    - Radiation therapy, stereotactic radiosurgery (SRS) and palliative radiation ≤ 14 days prior to the first dose of study drug.
    - Treatment with immunotherapy ≤ 28 days prior to the first dose of study drug.
    - Have any unresolved toxicity of Grade ≥ 2 from previous anti-cancer treatment, except for alopecia and skin pigmentation. Participants with chronic, but stable Grade 2 toxicities may be allowed to enroll after agreement between the Investigator and Sponsor.
    - Any history of primary brain or leptomeningeal disease (symptomatic or asymptomatic), presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require local treatment (such as radiotherapy or surgery).
    - History of spinal cord compression or brain metastases with the following exceptions:
    a. Participants with treated brain metastases that are asymptomatic at screening and who are off or receiving low-dose corticosteroids (≤10 mg prednisone or equivalent) for at least 7 days prior to first dose of BAY 2927088 are eligible to enroll in Dose Escalation and Backfill.
    b. Participants with treated brain metastases that are asymptomatic at screening are eligible in Dose Expansion/Extension (with the exception of Group G) if all of the following criteria are met:
    • there is no evidence of progression (new or enlarging brain metastases) for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period.
    • Participants must be off or receiving low-dose corticosteroids (≤10 mg prednisone or equivalent) for 7 days prior to first dose of BAY2927088.
    c. Participants with history of spinal cord compression >3 months from definitive therapy and stable by imaging (MRI or CT) during the screening period and clinically asymptomatic.
    d. Expansion Group G only: Participants with active (new or progressing) clinically stable brain metastases who do not require immediate CNS-directed treatment as per Investigator’s judgement and who are off or receiving low-dose corticosteroids (≤10 mg prednisone or equivalent such as ≤ 1.5 mg/day dexamethasone) in the 7 days prior to first dose of BAY2927088 are eligible.
    - History of congestive heart failure (CHF) Class >II according to the New York Heart Association (NYHA) Functional Classification or serious cardiac arrhythmias requiring treatment (e.g. ventricular arrhythmias, atrial fibrillation) or any clinically important abnormalities in rhythm, conduction or morphology or resting ECG (e.g., complete left
    bundle branch block, third degree heart block, second degree heart block, PR interval >250 msec)
    - Participants with:
    a. Known human immunodeficiency virus (HIV), except as noted below: Participants with history of HIV infection are eligible at the Investigator’s discretion provided that: • CD4+ T-cell (CD4+) counts are ≥ 350 cells/uL • The participant has been on established antiretroviral therapy (ART) for at least 4 weeks prior to the start of study drug and has an HIV viral load less than 400 copies/mL prior to start of the study treatment • The ART being used does not contain strong inducers or inhibitors of CYP3A4, and is not anticipated to cause overlapping toxicities with study drug • The participant has not had an opportunistic infection within the past 12 months
    b. Active Hepatitis B infection (positive for Hepatitis B surface antigen [HbsAg]) and Hepatitis B virus [HBV] DNA).
    c. Active Hepatitis C infection (positive anti-HCV Antibody and quantitative HCV RNA results greater than the lower limits of detection of the assay).
    NOTE: Participants with history of chronic HBV or HCV infection are eligible at the Investigator’s discretion provided that the disease is stable and sufficiently controlled under treatment.
    - Use of strong CYP3A4 inhibitors and inducers from 14 days prior to first administration of study drug. Strong CYP3A4 inhibitors and inducers are prohibited during the study and until Safety FU (follow up) visit.

Trial summary

Enrollment Goal
370
Trial Dates
October 2021 - December 2026
Phase
Phase 1/Phase 2
Could I Receive a placebo
No
Products
BAY2927088
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Active, not recruiting
National Taiwan University HospitalTaipei, 100, Taiwan
Active, not recruiting
Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - DetroitDetroit, 48202, United States
Active, not recruiting
Dana-Farber Cancer InstituteBoston, 02215, United States
Completed
City of Hope - Duarte Cancer CenterDuarte, 91010, United States
Active, not recruiting
National University Hospital Medical CentreSingapore, 119074, Singapore
Active, not recruiting
National Cancer Center SingaporeSingapore, 168583, Singapore
Active, not recruiting
Shanghai Chest Hospital, Shanghai Jiaotong UniversityShanghai, 200030, China
Active, not recruiting
Beijing Cancer HospitalBeijing, 100142, China
Active, not recruiting
West China Hospital Sichuan UniversityChengdu, 610041, China
Active, not recruiting
Zhejiang Cancer HospitalHangzhou, 310022, China
Active, not recruiting
Prince of Wales HospitalHong Kong, MISSING, Hong Kong
Active, not recruiting
Emory Winship Cancer InstituteAtlanta, 30322, United States
Active, not recruiting
University of Texas MD Anderson Cancer CenterHouston, 77030, United States
Active, not recruiting
Ciutat Sanitaria i Universitaria de la Vall d'HebronBarcelona, 08035, Spain
Active, not recruiting
Institut Català d'Oncologia HospitaletHospitalet de Llobregat, 08907, Spain
Active, not recruiting
Fundacion Jimenez Diaz (Clinica de la Concepcion)Madrid, 28040, Spain
Active, not recruiting
Taichung Veterans General HospitalTaichung, 40705, Taiwan
Active, not recruiting
National Cancer Center Hospital EastKashiwa, 277-8577, Japan
Active, not recruiting
National Cancer Center HospitalChuo-ku, 104-0045, Japan
Completed
Shizuoka Cancer CenterSunto, 411-8777, Japan
Active, not recruiting
Asan Medical CenterSeoul, 05505, Korea,_republic_of
Active, not recruiting
Seoul National University HospitalSeoul, 3080, Korea,_republic_of
Withdrawn
Istituto Nazionale Tumori IRCCS Fondazione G.PascaleNapoli, 80131, Italy
Active, not recruiting
Centro di Riferimento Oncologico di Aviano - Oncologia Medica e dei Tumori Immuno-CorrelatiAviano, 33081, Italy
Active, not recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Fase IRoma, 00128, Italy
Not yet recruiting
NYU Langone HealthMineola, 11501, United States
Withdrawn
Roswell Park Comprehensive Cancer CenterBuffalo, 14263-0001, United States
Active, not recruiting
Institut Gustave Roussy - Département de Médecine OncologiqueVILLEJUIF CEDEX, 94805, France
Active, not recruiting
Institut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicaleBordeaux, 33000, France
Active, not recruiting
Institut Curie - Paris - Oncologie medicaleParis, 75248, France
Active, not recruiting
Tottori University HospitalYonago, 683-8504, Japan
Active, not recruiting
Osaka International Cancer InstituteOsaka-shi, 541-8567, Japan
Active, not recruiting
Seoul National University Bundang HospitalSeongnam-si, 13620, Korea,_republic_of
Active, not recruiting
Severance Hospital, Yonsei University Health SystemSeoul, 03722, Korea,_republic_of
Active, not recruiting
Union Hospi, Tongji Med College, Huazhong Univ. Scien&TechWuhan, 430023, China
Active, not recruiting
Hunan Cancer HospitalChangsha, 410013, China
Active, not recruiting
NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med SchoolNanjing, 210008, China
Completed
City of Hope - Duarte Cancer CenterDuarte, 91010, United States
Active, not recruiting
UZ Leuven Gasthuisberg - Pneumology DepartmentLeuven, 3000, Belgium
Active, not recruiting
IPO PortoPorto, 4200-072, Portugal
Withdrawn
Hospital Santa Maria | Centro de Investigacao ClinicaMISSING, 1649-035, Portugal
Completed
Centro Integral Oncológico Clara CampalMadrid, 28050, Spain
Active, not recruiting
Hospital Universitari i Politecnic La Fe | OncologiaValencia, 46026, Spain
Active, not recruiting
Hospital Quiron DexeusBarcelona, 08028, Spain
Active, not recruiting
AZ Delta | Clinical Trial Center - PneumologyRoeselare, 8800, Belgium
Withdrawn
Uniwersyteckie Centrum KliniczneGdansk, 80-214, Poland
Withdrawn
SP ZOZ USK im. WAM UM w Lodzi - Centralny Szpital WeteranowLodz, 92-213, Poland
Active, not recruiting
Queen Mary HospitalHong Kong, MISSING, Hong Kong
Active, not recruiting
Humanitas Mirasole S.p.A. - Oncologia Medica ed EmatologiaRozzano, 20089, Italy
Active, not recruiting
Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Oncologia MedicaOrbassano, 10043, Italy
Active, not recruiting
Azienda Ospedaliero Universitaria Parma - SC Oncologia MedicaParma, 43126, Italy
Completed
Istituto Europeo di Oncologia s.r.l - Sviluppo di nuovi farmaci per Terapie InnovativeMilano, 20141, Italy
Active, not recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1Milano, 20133, Italy
Recruiting
Hospital Israelita Albert Einstein | Morumbi - Clinical Research DepartmentSao Paulo, 05651-901, Brazil
Active, not recruiting
Harbin Medical University Cancer HospitalHarbin, 150000, China
Active, not recruiting
Sir Run Run Shaw Hospital, Zhejiang Univ. School of MedicineHangzhou, 310016, China
Active, not recruiting
Fujian Cancer HospitalFuzhou, 350014, China
Active, not recruiting
Qilu Hosp., Shandong Univ.Jinan, 250000, China
Active, not recruiting
Beijing HospitalBeijing, 100730, China
Active, not recruiting
UNICANCER - Centre Leon-Berard (CLB) - Medical oncologyLyon Cedex 08, 69373, France
Active, not recruiting
Institut de Cancérologie de l'Ouest - Saint Herblain - Oncologie medicaleSaint Herblain, 44800, France
Completed
Banner MD Anderson Cancer Center at Banner Gateway Medical CenterGilbert, 85234, United States
Active, not recruiting
Virginia Cancer Specialists, PCFairfax, 22031, United States
Recruiting
The Center for Cancer and Blood DisordersBethesda, 20817, United States
Recruiting
Tennessee OncologyNashville, 37203, United States
Active, not recruiting
Chaim Sheba Medical CenterRamat Gan, 5262000, Israel
Active, not recruiting
Rabin Medical Center | Beilinson Hospital - Internal Medicine C DepartmentPetach Tikva, 4941492, Israel
Active, not recruiting
Nederlands Kanker InstituutAMSTERDAM, 1066 CX, Netherlands
Active, not recruiting
Erasmus University Medical Center | Research Department - Lung DiseasesRotterdam, 3015GD, Netherlands
Active, not recruiting
Hokkaido University HospitalSapporo, 060-8648, Japan
Active, not recruiting
Kanagawa Cancer CenterYokohama, 241-8515, Japan
Active, not recruiting
National Hospital Organization Shikoku Cancer CenterMatsuyama, 791-0280, Japan
Active, not recruiting
Aichi Cancer Center HospitalNagoya, 464-8681, Japan
Active, not recruiting
St.Vincent's HospitalSuwon-si, 16247, Korea,_republic_of
Active, not recruiting
Chungbuk National University HospitalCheongju-si, 28644, Korea,_republic_of
Active, not recruiting
Chang Gung Memorial Hospital at LinkouTaoyuan, 33305, Taiwan
Active, not recruiting
National Cheng Kung University HospitalTainan, 704, Taiwan
Recruiting
Hospital de Base | Integrated Research CenterSão José do Rio Preto, 15090-000, Brazil
Active, not recruiting
Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa ClínicaNatal, 59040-000, Brazil
Withdrawn
START Lisbon, CHULN - Centro Hospitalar Universitário de Lisboa NorteLisbon, 1649-028, Portugal
Withdrawn
Hopital de la Timone - Marseille - Centre d'Essais en CancerologieMarseille, 13005, France
Active, not recruiting
Hopital Nord Laennec - Oncologie medicale thoracique et digestiveNantes, 44093, France
Active, not recruiting
Curie Oncology | Mount Elizabeth NovenaSingapore, 329563, Singapore
Withdrawn
Hospital Universitario Virgen de la Victoria | OncologyMálaga, 29010, Spain
Active, not recruiting
Kindai University HospitalOsakasayama, 589-8511, Japan
Active, not recruiting
Okayama University HospitalOkayama, 700-8558, Japan
Withdrawn
Radboud University Medical Center | Afdeling Interne GeneeskundeNijmegen, 6500 HB, Netherlands
Completed
Centro Ricerche Cliniche Di Verona S.r.l. - OncologiaVerona, 37134, Italy
Active, not recruiting
Zhejiang University School of Medicine - Taizhou Hospital of Zhejiang ProvinceTaizhou, 317000, China
Active, not recruiting
Chi-Mei Medical Center, LiouyineTainan, 73657, Taiwan
Withdrawn
Chung Shan Medical University HospitalTaichung, 402306, Taiwan
Withdrawn
Hong Kong United Oncology CentreKowloon, Hong Kong
Active, not recruiting
Samsung Medical CenterSeoul, 6351, Korea,_republic_of
Withdrawn
Taipei Medical University (TMU) - Shuang Ho Hospital (SHH)Taipei, 23561, Taiwan
Active, not recruiting
Shandong University - Shandong Cancer HospitalJinan, 250117, China

Primary Outcome

  • Number of participants with treatment-emergent adverse events (TEAEs)
    date_rangeTime Frame:
    Up to 30 days after the last administration of study treatment
  • Number of participants with treatment-emergent serious adverse events (TESAEs)
    date_rangeTime Frame:
    Up to 30 days after the last administration of study treatment
  • Severity of TEAEs
    date_rangeTime Frame:
    Up to 30 days after the last administration of study treatment
  • Severity of TESAEs
    date_rangeTime Frame:
    Up to 30 days after the last administration of study treatment
  • Number of participants who discontinue study treatment due to an AE
    date_rangeTime Frame:
    About 4 years (Up to the end of study treatment)
  • Maximum tolerated dose (MTD) or maximum administered dose (MAD) of BAY2927088 within the DLT observation period in Dose Escalation (including participants from Backfill qualifying for the MTD population)
    date_rangeTime Frame:
    At the end of Cycle 1 of a 21-day cycle
  • Number of participants experiencing dose-limiting toxicities (DLTs) at each dose level associated with administration of BAY2927088 in the DLT observation period in Dose Escalation (including participants from Backfill)
    In Dose Escalation (including participants from Backfill)
    date_rangeTime Frame:
    At the end of Cycle 1 of a 21-day cycle
  • Cmax of BAY2927088
    Cmax: Maximum/peak concentration
    date_rangeTime Frame:
    Cycle 1, Day 1 (Cycle duration is 21 days)
  • AUC(0-24) of BAY2927088 for QD
    AUC: Area under the concentration vs. time curve. AUC(0-24): AUC from time 0 to 24 hours post dose. QD: Quaque die (once daily)
    date_rangeTime Frame:
    Cycle 1, Day 1 (Cycle duration is 21 days)
  • AUC(0-12) of BAY2927088 for BID
    If applicable. AUC(0-12): AUC from time 0 to 12 hours post dose. BID: Bis in die, 2 times daily.
    date_rangeTime Frame:
    Cycle 1, Day 1 (Cycle duration is 21 days)
  • Cmax,md of BAY2927088
    Cmax,md: Cmax after multiple dose administrations
    date_rangeTime Frame:
    Cycle 1, Day 15 (Cycle duration is 21 days)
  • AUC(0-24)md of BAY2927088 for QD
    AUC(0-24)md: AUC(0-24) after multiple dose administrations
    date_rangeTime Frame:
    Cycle 1, Day 15 (Cycle duration is 21 days)
  • AUC(0-12)md of BAY2927088 for BID
    If applicable AUC(0-12)md: AUC(0-12) after multiple dose administrations
    date_rangeTime Frame:
    Cycle 1, Day 15 (Cycle duration is 21 days)
  • Overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) by blinded independent central review (BICR) in extension part
    date_rangeTime Frame:
    From the start of the study treatment up to 12 months

Secondary Outcome

  • Overall response rate (ORR) as per RECIST v1.1 by investigator assessment
    RECIST v1.1: Response Evaluation Criteria in Solid Tumors, version 1.1
    date_rangeTime Frame:
    About 4 years
  • Recommended phase 2 dose (RP2D) of BAY2927088
    date_rangeTime Frame:
    About 1.5 years
  • ORR per RECIST v1.1 by Investigator assessment in extension part
    date_rangeTime Frame:
    From the start of the study treatment up to 12 months
  • Disease control rate (DCR) per RECIST v1.1 by Investigator assessment and BICR in extension part
    date_rangeTime Frame:
    From the start of the study treatment up to 12 months
  • Duration of response (DOR) per RECIST 1.1 by Investigator assessment and BICR in extension part
    date_rangeTime Frame:
    From the start of the study treatment up to 12 months
  • Progression-free survival (PFS) per RECIST 1.1 by Investigator assessment and BICR in extension part
    date_rangeTime Frame:
    From the start of the study treatment up to 12 months
  • Overall survival (OS) in extension part
    date_rangeTime Frame:
    From the start of the study treatment up to 12 months
  • Number of participants with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) categorized by severity in extension part
    date_rangeTime Frame:
    Up to 30 days after the last administration of study treatment

Trial design

An open label, first-in-human study of BAY 2927088 in participants with advanced non-small cell lung cancer (NSCLC) harboring an EGFR and/or HER2 mutation
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
N/A
Assignment
Sequential Assignment
Trial Arms
4