A Phase 2, Open-Label, Parallel Cohort Study of Subcutaneous Amivantamab in Multiple Regimens in Patients With Advanced or Metastatic Solid Tumors Including EGFR-mutated Non-Small Cell Lung Cancer

Status: Recruiting
Location: See all (110) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The purpose of this study is to assess the anti-tumor activity and safety of amivantamab which will be administered as a co-formulation with recombinant human hyaluronidase PH20 (rHuPH20) (subcutaneous co-formulation \[SC-CF\]) in combination treatment (all cohorts except Cohort 4) and to characterize the safety of amivantamab SC-CF (Cohort 4).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participant must have histologically or cytologically confirmed, locally advanced or metastatic, non-small cell lung cancer (NSCLC) that is not amenable to curative therapy including surgical resection or chemoradiation. Additional Cohort specific disease requirements include: Cohorts 1, 3, 3b, 5, 6 and 7: epidermal growth factor receptor (EGFR) exon 19 deletion (Exon19del) or Exon 21 L858R mutation; Cohort 2: EGFR Exon 20ins mutation. Cohorts 1,5,and6: Participant should not have received any prior systemic therapy for locally advanced or metastatic NSCLC. Cohort 2: Participant should not have received any prior systemic therapy for locally advanced or metastatic NSCLC. Cohorts 3and3b: Participant must have progressed on or after osimertinib monotherapy as the most recent line of treatment. Osimertinib must have been administered as either the first-line treatment for locally advanced or metastatic disease or in the second-line setting after prior treatment with first- or second-generation EGFR tyrosine kinase inhibitor (TKI) as a monotherapy. Cohort 4: Participants need to currently be on an amivantamab IV Q2W regimen (1,050 mg or 1,400 mg depending on weight) for at least 8 weeks, as part of standard of care, an expanded access program, or as a rollover from a long-term extension, without any amivantamab dose reduction. Cohort 7: Participants must have progressed on or after the combination of amivantamab and lazertinib as the most recent line of treatment. The combination of amivantamab and lazertinib must have been administered as the first-line treatment for locally advanced or metastatic disease. Cohort 2, 3, 3b, and 7 only: Squamous NSCLC are excluded. EGFR mutation must have been identified as determined by Food and Drug Administration (FDA) approved or other validated test of either circulating tumor deoxyribonucleic acid (ctDNA) or tumor tissue in a clinical laboratory improvement amendments (CLIA) certified laboratory (sites in the United states \[US\]) or an accredited local laboratory (sites outside of the US). A copy of the initial test report documenting the EGFR mutation must be included in the participant records and a deidentified copy must also be submitted to the sponsor

• All cohorts except Cohort 4: Participants must have at least 1 measurable lesion, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. If the only target lesion has been previously irradiated, it must show signs of disease progression since radiation was completed If only 1 non-irradiated measurable lesion exists, which undergoes a biopsy and is acceptable as a target lesion, the baseline tumor assessment scans should be performed at least 14 days after the biopsy

• May have a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)

• Have adequate organ (renal, hepatic, hematological, coagulation and cardiac) functions

• Participant must have eastern cooperative oncology group (ECOG) status of 0 or 1

• Cohort 6: Must be eligible for, and agree to comply with, the use of prophylactic anticoagulation with a direct oral anticoagulant or a low molecular weight heparin during the first 4 months of study treatment

• A participant must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for a period of 6 months after receiving the last dose of study treatment. Participants with child bearing potential should consider preservation of eggs prior to study treatment as anti-cancer treatments may impair fertility

Locations
United States
California
University of California at San Diego
RECRUITING
La Jolla
University of California Irvine
RECRUITING
Orange
Stanford Cancer Institute
RECRUITING
Stanford
Washington, D.c.
Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital
RECRUITING
Washington D.c.
Florida
Baptist Lynn Cancer Institute
COMPLETED
Boca Raton
Mount Sinai Medical Center
RECRUITING
Miami Beach
AdventHealth
RECRUITING
Orlando
H. Lee Moffitt Cancer & Research Institute
COMPLETED
Tampa
Kansas
University of Kansas Cancer Center
RECRUITING
Westwood
Massachusetts
Boston Medical Center
RECRUITING
Boston
Maryland
Sidney Kimmel Cancer Center - Bayview Campus
RECRUITING
Baltimore
Missouri
Washington University School Of Medicine
RECRUITING
St Louis
North Carolina
Novant Health
COMPLETED
Charlotte
Novant Health
COMPLETED
Winston-salem
New Jersey
Hackensack University Medical Center
RECRUITING
Hackensack
Rutgers Cancer Institute of New Jersey
RECRUITING
New Brunswick
New York
Hematology-Oncology Associates of CNY
COMPLETED
East Syracuse
Ohio
Cleveland Clinic
COMPLETED
Cleveland
Cleveland Clinic
COMPLETED
Cleveland
Cleveland Clinic
COMPLETED
Mayfield Heights
Cleveland Clinic
COMPLETED
Warrensville Heights
Utah
The Huntsman Cancer Institute
COMPLETED
Salt Lake City
Virginia
Virginia Cancer Specialists
RECRUITING
Fairfax
Washington
Providence Regional Cancer Partnership
COMPLETED
Everett
Swedish Cancer Institute
RECRUITING
Seattle
Virginia Mason Medical Center
COMPLETED
Seattle
Other Locations
Brazil
Fundacao Pio XII
RECRUITING
Barretos
PERSONAL Oncologia de Precisao e Personalizada
RECRUITING
Belo Horizonte
Instituto do Cancer de Londrina Hospital do Cancer de Londrina
RECRUITING
Londrina
Associacao Hospitalar Moinhos de Vento
RECRUITING
Porto Alegre
Instituto D Or de Pesquisa e Ensino IDOR
RECRUITING
Rio De Janeiro
Instituto D Or de Pesquisa e Ensino IDOR
RECRUITING
Salvador
Fundacao Antonio Prudente A C Camargo Cancer Center
RECRUITING
São Paulo
Hospital Alemao Oswaldo Cruz
RECRUITING
São Paulo
Impar Servicos Hospitalares SA Hospital Nove de Julho
RECRUITING
São Paulo
China
Affiliated Hospital of Hebei University
RECRUITING
Baoding
Jilin cancer hospital
RECRUITING
Changchun
Sichuan Cancer Hospital
RECRUITING
Chengdu
West China Hospital Sichuan University
RECRUITING
Chengdu
The First Affiliated Hospital of PLA Army Medical University
RECRUITING
Chongqing
The First Affiliated Hospital Sun Yat sen University
RECRUITING
Guangzhou
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
RECRUITING
Hangzhou
The First Affiliated Hospital Zhejiang University College of Medicine
RECRUITING
Hangzhou
Harbin medical university cancer hospital
RECRUITING
Harbin
Huizhou Municipal Central Hospital
RECRUITING
Huizhou
Liuzhou people's Hospital
COMPLETED
Liuzhou
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Tianjin Medical University General Hospital
RECRUITING
Tianjin
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
RECRUITING
Wuhan
Hospital of Jiangnan University
COMPLETED
Wuxi
The First Affiliated Hospital of Xian Jiaotong University
RECRUITING
Xi'an
Yantai Yuhuangding Hospital
COMPLETED
Yantai
France
Centre Francois Baclesse
RECRUITING
Caen
Centre Georges-François Leclerc
COMPLETED
Dijon
Institut de Cancérologie du Gard
RECRUITING
Nîmes
Institut Curie
RECRUITING
Paris
Institut de cancerologie de l'ouest
RECRUITING
Saint-herblain
Gustave Roussy
RECRUITING
Villejuif
Germany
Evangelische Lungenklinik Berlin
COMPLETED
Berlin
Universitaetsklinikum Koelnt
RECRUITING
Cologne
LungenClinic Grosshansdorf GmbH
RECRUITING
Grosshandorf
Lungenfachklinik Immenhausen
RECRUITING
Immenhausen
Klinikum Würzburg Mitte gGmbH Standort Missioklinik
RECRUITING
Würzburg
Israel
Rambam Medical Center
RECRUITING
Haifa
Shaare Zedek Medical Center
RECRUITING
Jerusalem
Meir Medical Center
RECRUITING
Kfar Saba
Rabin Medical Center
RECRUITING
Petah Tikva
Sheba Medical Center
RECRUITING
Ramat Gan
Italy
Policlinico Hospital San Martino- IRCCS for Oncology
RECRUITING
Genova
ASST Grande Ospedale Metropolitano Niguarda
RECRUITING
Milan
Ospedale San Raffaele
RECRUITING
Milan
Azienda Ospedaliera San Gerardo
RECRUITING
Monza
Azienda Ospedaliera Specialistica dei Colli
RECRUITING
Naples
Japan
National Hospital Organization Himeji Medical Center
ACTIVE_NOT_RECRUITING
Himeji
Matsusaka Municipal Hospital
ACTIVE_NOT_RECRUITING
Matsusaka
Niigata Cancer Center Hospital
ACTIVE_NOT_RECRUITING
Niigata
Shizuoka Cancer Center
ACTIVE_NOT_RECRUITING
Shizuoka
The Cancer Institute Hospital of JFCR
ACTIVE_NOT_RECRUITING
Tokyo
Wakayama Medical University Hospital
ACTIVE_NOT_RECRUITING
Wakayama
Malaysia
University Malaya Medical Centre
RECRUITING
Kuala Lumpur
Hospital Tengku Ampuan Afzan
RECRUITING
Kuantan
Hospital Umum Sarawak
RECRUITING
Kuching
Beacon Hospital Sdn Bhd
RECRUITING
Petaling Jaya
Republic of Korea
National Cancer Center
RECRUITING
Goyang-si
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Asan Medical Center
COMPLETED
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital Yonsei University Health System
RECRUITING
Seoul
Spain
Hosp Univ A Coruna
RECRUITING
A Coruña
General University Hospital of Alicantet
RECRUITING
Alicante
Hosp Univ Vall D Hebron
RECRUITING
Barcelona
Hosp. de La Santa Creu I Sant Pau
RECRUITING
Barcelona
Hosp. Del Mar
RECRUITING
Barcelona
Inst. Cat. Doncologia-H Duran I Reynals
RECRUITING
Barcelona
Hosp. Gral. Univ. Gregorio Maranon
RECRUITING
Madrid
Hosp. Univ. 12 de Octubre
RECRUITING
Madrid
Hosp. Univ. La Paz
RECRUITING
Madrid
Hosp. Univ. Ramon Y Cajal
RECRUITING
Madrid
Hosp Regional Univ de Malaga
RECRUITING
Málaga
Hosp. Virgen Macarena
RECRUITING
Seville
Hosp. Clinico Univ. de Valencia
RECRUITING
Valencia
Hosp. Gral. Univ. Valencia
RECRUITING
Valencia
United Kingdom
Cheltenham General Hospital
COMPLETED
Cheltenham
Torbay Hospital-Devon
RECRUITING
Devon
Edinburgh Cancer Centre Western General
RECRUITING
Edinburgh
Leicester Royal Infirmary
RECRUITING
Leicester
University College London Hospitals
RECRUITING
London
Nottingham City Hospital
RECRUITING
Nottingham
Queen Alexandra Hospital
RECRUITING
Portsmouth
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date: 2022-11-11
Estimated Completion Date: 2027-08-17
Participants
Target number of participants: 520
Treatments
Experimental: Cohort 1(Exon19del/Exon21 L858R NSCLC, 1L, Previously Untreated): Amivantamab (Q2W) + Lazertinib
Participants with treatment-naive locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring an epidermal growth factor receptor (EGFR) exon 19 deletion (exon19del) or exon 21 leucine 858 to arginine substitution (exon 21 L858R) mutation, will receive amivantamab SC-CF injection, 1600 milligrams (mg) or 2240 mg if body weight is greater than or equal to (\>=) 80 kilograms (kg), on Cycle 1 Days 1, 8, 15, and 22 and on Days 1 and 15 of each subsequent 28-day cycle, starting with Cycle 2, along with lazertinib 240 mg orally once daily. Eligible participants will be given an option to enter long-term extension (LTE) phase and may continue to receive access to study treatment(s) within the study by transferring to the Drug Access (DA)-LTE Phase.
Experimental: Cohort 2(Exon20 NSCLC,1L, Previously Untreated): Amivantamab (Q3W) + Chemotherapy
Participants with treatment-naive locally advanced or metastatic NSCLC harboring an EGFR exon20ins mutation will receive Amivantamab SC-CF injection 1600 mg or 2240 mg if body weight is \>=80 kg on Cycle 1 Day 1, 2400 mg or 3360 mg if body weight is \>=80 kg on Cycle 1 Day 8 and 15 and on Day 1 of each subsequent 21-day cycle, starting with Cycle 2 along with pemetrexed 500 milligrams per meter square (mg/m\^2) as intravenous (IV) infusion (with vitamin supplementation) on Day 1 of each 21-day cycle and IV infusion carboplatin area under the concentration-time curve 5 milligrams per milliliters (mg/mL) per minute (AUC 5) maximum 750 mg on Day 1 of each 21-day cycle, for up to 4 cycles. Eligible participants will be given an option to enter LTE phase and may continue to receive access to study treatment(s) within the study by transferring to the DA-LTE Phase.
Experimental: Cohort 3(Exon19del/Exon21 L858R NSCLC,2L,Post Osimertinib):Amivantamab(Q3W)+Lazertinib+Chemotherapy
Participants with locally advanced or metastatic NSCLC harboring an EGFR exon19del or exon 21 L858R mutation who have experienced disease progression on or after treatment with a third-generation EGFR TKI (osimertinib), will receive amivantamab SC-CF injection 1600 mg or 2240 mg if body weight is \>=80 kg on Cycle 1 Day 1, 2400 mg or 3360 mg if body weight is \>=80 kg on Cycle 1 Day 8 and 15 and on Day 1 of each subsequent 21-day cycle starting with Cycle 2; in combination with IV infusion carboplatin area under the concentration-time curve 5 mg/mL per minute (AUC 5) maximum 750 mg on Day 1 of each 21-day cycle, for up to 4 cycles; and pemetrexed 500 mg/m\^2 as an IV infusion (with vitamin supplementation) on Day 1 of each 21-day until disease progression. Lazertinib 240 mg orally once daily starting Cycle 5 Day 1 when carboplatin is complete or sooner if carboplatin discontinued earlier than Cycle 4. Eligible participants will be given an option to enter LTE phase and DA-LTE Phase.
Experimental: Cohort 3b(Exon19del/Exon21 L858R NSCLC, 2L, Post Osimertinib): Amivantamab (Q3W)+Chemotherapy
Participants with locally advanced or metastatic NSCLC harboring an EGFR exon19del or exon 21 L858R mutation who have experienced disease progression on or after treatment with a third-generation EGFR TKI (osimertinib), will receive amivantamab SC-CF injection 1600 mg or 2240 mg if body weight is \>=80 kg on Cycle 1 Day 1, 2400 mg or 3360 mg if body weight is \>=80 kg on Cycle 1 Day 8 and 15 and on Day 1 of each subsequent 21-day cycle starting with Cycle 2; in combination with IV infusion carboplatin area under the concentration-time curve 5 mg/mL per minute (AUC 5) maximum 750 mg on Day 1 of each 21-day cycle, for up to 4 cycles; and pemetrexed 500 mg/m\^2 as an IV infusion (with vitamin supplementation) on Day 1 of each 21-day until disease progression. Eligible participants will be given an option to enter LTE phase and may continue to receive access to study treatment(s) within the study by transferring to the DA-LTE Phase.
Experimental: Cohort 4(Previously Treated with Amivantamab IV): Switch from Amivantamab IV to SC-CF (Q2W)
Participants who were previously on amivantamab IV once every 2 weeks (Q2W) regimen as part of standard of care, for at least 8 weeks, either as monotherapy or combination with lazertinib, will receive amivantamab SC-CF injection 1600 mg and 2240 mg if body weight is greater than or equal to 80 kg. Participants who continue to benefit from study treatments, as determined by their investigator, may shift to the drug access (DA)-LTE phase.
Experimental: Cohort 5(Exon19del/Exon21 L858R NSCLC, 1L, Previously Untreated): Amivantamab (Q4W) + Lazertinib
Participants with treatment-naïve locally advanced or metastatic NSCLC harboring an EGFR Exon19del or Exon 21 L858R mutation will receive amivantamab SC-CF induction with 1,600 mg (or 2,240 mg if BW \>=80 kg) on Cycle 1 Days 1, 8, 15, and 22, starting with Cycle 2 on Day 1 of each next 28-day cycle, amivantamab SC-CF (160 mg/mL co-formulated with rHuPH20) by manual injection at 3,520 mg (or 4,640 mg if BW \>=80 kg); along with lazertinib 240 mg by mouth once daily from Cycle 1 Day 1. Eligible participants will be given an option to enter LTE phase and may continue to receive access to study treatment(s) within the study by transferring to the DA-LTE Phase.
Experimental: Cohort6(Exon19del/Exon21L858R,NSCLC1L,PreviouslyUntreated):Amivantamab(Q2W)+Lazertinib+Anticoagulant
Participants with treatment-naive locally advanced or metastatic NSCLC harboring an EGFR Exon19del or Exon 21 L858R mutation treated will receive will receive amivantamab SC-CF injection, 1600 milligrams (mg) and 2240 mg if body weight is greater than or equal to (\>=) 80 kilograms (kg), on Cycle 1 Days 1, 8, 15, and 22 and on Days 1 and 15 of each subsequent 28-day cycle, starting with Cycle 2, along with lazertinib 240 mg orally once daily from Cycle 1 Day 1. Participants will additionally take prophylactic anticoagulation with a direct oral anticoagulant (DOAC) or a low molecular weight heparin (LMWH) for the first four months of study treatment (from Day 1 through Day 120) with the combination of amivantamab and lazertinib. Eligible participants will be given an option to enter LTE phase and may continue to receive access to study treatment(s) within the study by transferring to the DA-LTE Phase.
Experimental: Cohort 7(Exon19del/Exon21 L858R NSCLC,2L,Post Amivantamab+Lazertinib):Amivantamab(Q3W)+Chemotherapy
Participants with locally advanced or metastatic NSCLC harboring an EGFR exon19del or exon 21 L858R mutation who have experienced disease progression on or after the combination of amivantamab and lazertinib will receive amivantamab SC-CF injection 1600 mg or 2240 mg if body weight is \>=80 kg on Cycle 1 Day 1, 2400 mg or 3360 mg if body weight is \>=80 kg on Cycle 1 Day 8 and 15 and on Day 1 of each subsequent 21-day cycle starting with Cycle 2; in combination with IV infusion carboplatin area under the concentration-time curve 5 mg/mL per minute (AUC 5) maximum 750 mg on Day 1 of each 21-day cycle, for up to 4 cycles; and pemetrexed 500 mg/m\^2 as an IV infusion (with vitamin supplementation) on Day 1 of each 21-day until disease progression. Eligible participants will be given an option to enter LTE phase and may continue to receive access to study treatment(s) within the study by transferring to the DA-LTE Phase.
Sponsors
Leads: Janssen Research & Development, LLC

This content was sourced from clinicaltrials.gov

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