A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer

NCT05498428 | Recruiting Phase 2 DMC FDA Drug

• 4 other identifiers: CR10926461186372NSC20022022-000526-212023-505065-91-00
• Study Type: interventional
• Target: 520
• Locations: 12 countries
• Sites: 110

Brief 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).

Conditions

Carcinoma, Non-small-Cell Lung

Outcome Measures

Primary Outcomes (5)

• All Cohorts Except Cohort 4: Objective Response Rate (ORR) Based on Investigator Assessment (INV)

  ORR based on INV will be reported. ORR is defined as the percentage of participants who achieve a complete response (CR) or partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as determined by investigator.

  Up to 1 year 6 months

• Cohort 4: Number of Participants with Adverse Events (AEs)

  An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study.

  Up to approximately 4 years and 9 months

• Cohort 4: Number of Participants with AEs by Severity

  An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.

  Up to approximately 4 years and 9 months

• Cohort 4: Number of Participants with Abnormalities in Clinical Laboratory Values

  Number of participants with abnormalities in clinical laboratory values (which includes serum chemistry, hematology, coagulation, urinalysis, and serology) will be reported.

  Up to approximately 4 years and 9 months

• Cohort 4: Number of Participants with Abnormalities in Clinical Laboratory Values by Severity

  Number of participants with laboratory values abnormalities which includes serum chemistry, hematology, coagulation, urinalysis, and serology) by severity will be reported. Severity of laboratory values abnormalities will be graded according to the NCI-CTCAE version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.

  Up to approximately 4 years and 9 months

Secondary Outcomes (17)

• All Cohorts Except Cohort 4: Number of Participants with AEs

  Up to 1 year 6 months

• All Cohorts Except Cohort 4: Number of Participants with AEs by Severity

  Up to 1 year 6 months

• All Cohorts Except Cohort 4: Number of Participants with Abnormalities in Clinical Laboratory Values

  Up to 1 year 6 months

• All Cohorts Except Cohort 4: Number of Participants with Abnormalities in Clinical Laboratory Values by Severity

  Up to 1 year 6 months

• All Cohorts Except Cohort 4: ORR Based on Independent Central Review (ICR)

  Up to 1 year 6 months

Study Arms (8)

Cohort 1(Exon19del/Exon21 L858R NSCLC, 1L, Previously Untreated): Amivantamab (Q2W) + Lazertinib

EXPERIMENTAL

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.

Drug: Amivantamab; Drug: Lazertinib

Cohort 2(Exon20 NSCLC,1L, Previously Untreated): Amivantamab (Q3W) + Chemotherapy

EXPERIMENTAL

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.

Drug: Amivantamab; Drug: Carboplatin; Drug: Pemetrexed

Cohort 3(Exon19del/Exon21 L858R NSCLC,2L,Post Osimertinib):Amivantamab(Q3W)+Lazertinib+Chemotherapy

EXPERIMENTAL

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.

Drug: Amivantamab; Drug: Lazertinib; Drug: Carboplatin; Drug: Pemetrexed

Cohort 3b(Exon19del/Exon21 L858R NSCLC, 2L, Post Osimertinib): Amivantamab (Q3W)+Chemotherapy

EXPERIMENTAL

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.

Drug: Amivantamab; Drug: Carboplatin; Drug: Pemetrexed

Cohort 4(Previously Treated with Amivantamab IV): Switch from Amivantamab IV to SC-CF (Q2W)

EXPERIMENTAL

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.

Drug: Amivantamab; Drug: Lazertinib

Cohort 5(Exon19del/Exon21 L858R NSCLC, 1L, Previously Untreated): Amivantamab (Q4W) + Lazertinib

EXPERIMENTAL

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.

Drug: Amivantamab; Drug: Lazertinib

Cohort6(Exon19del/Exon21L858R,NSCLC1L,PreviouslyUntreated):Amivantamab(Q2W)+Lazertinib+Anticoagulant

EXPERIMENTAL

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.

Drug: Amivantamab; Drug: Lazertinib; Drug: Direct Oral Anticoagulant (DOAC); Drug: Low Molecular Weight Heparin (LMWH)

Cohort 7(Exon19del/Exon21 L858R NSCLC,2L,Post Amivantamab+Lazertinib):Amivantamab(Q3W)+Chemotherapy

EXPERIMENTAL

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.

Drug: Amivantamab; Drug: Carboplatin; Drug: Pemetrexed

Interventions

Amivantamab DRUG

Amivantamab will be administered subcutaneously by manual injection.

Also known as: JNJ-61186372

Cohort 1(Exon19del/Exon21 L858R NSCLC, 1L, Previously Untreated): Amivantamab (Q2W) + Lazertinib; Cohort 2(Exon20 NSCLC,1L, Previously Untreated): Amivantamab (Q3W) + Chemotherapy; Cohort 3(Exon19del/Exon21 L858R NSCLC,2L,Post Osimertinib):Amivantamab(Q3W)+Lazertinib+Chemotherapy; Cohort 3b(Exon19del/Exon21 L858R NSCLC, 2L, Post Osimertinib): Amivantamab (Q3W)+Chemotherapy; Cohort 4(Previously Treated with Amivantamab IV): Switch from Amivantamab IV to SC-CF (Q2W); Cohort 5(Exon19del/Exon21 L858R NSCLC, 1L, Previously Untreated): Amivantamab (Q4W) + Lazertinib; Cohort 7(Exon19del/Exon21 L858R NSCLC,2L,Post Amivantamab+Lazertinib):Amivantamab(Q3W)+Chemotherapy; Cohort6(Exon19del/Exon21L858R,NSCLC1L,PreviouslyUntreated):Amivantamab(Q2W)+Lazertinib+Anticoagulant

Lazertinib DRUG

Lazertinib will be administered as an oral tablet.

Also known as: JNJ-73841937; YH25448

Cohort 1(Exon19del/Exon21 L858R NSCLC, 1L, Previously Untreated): Amivantamab (Q2W) + Lazertinib; Cohort 3(Exon19del/Exon21 L858R NSCLC,2L,Post Osimertinib):Amivantamab(Q3W)+Lazertinib+Chemotherapy; Cohort 4(Previously Treated with Amivantamab IV): Switch from Amivantamab IV to SC-CF (Q2W); Cohort 5(Exon19del/Exon21 L858R NSCLC, 1L, Previously Untreated): Amivantamab (Q4W) + Lazertinib; Cohort6(Exon19del/Exon21L858R,NSCLC1L,PreviouslyUntreated):Amivantamab(Q2W)+Lazertinib+Anticoagulant

Carboplatin DRUG

Carboplatin will be administrated by IV infusion.

Cohort 2(Exon20 NSCLC,1L, Previously Untreated): Amivantamab (Q3W) + Chemotherapy; Cohort 3(Exon19del/Exon21 L858R NSCLC,2L,Post Osimertinib):Amivantamab(Q3W)+Lazertinib+Chemotherapy; Cohort 3b(Exon19del/Exon21 L858R NSCLC, 2L, Post Osimertinib): Amivantamab (Q3W)+Chemotherapy; Cohort 7(Exon19del/Exon21 L858R NSCLC,2L,Post Amivantamab+Lazertinib):Amivantamab(Q3W)+Chemotherapy

Pemetrexed DRUG

Pemetrexed will be administered by IV infusion.

Cohort 2(Exon20 NSCLC,1L, Previously Untreated): Amivantamab (Q3W) + Chemotherapy; Cohort 3(Exon19del/Exon21 L858R NSCLC,2L,Post Osimertinib):Amivantamab(Q3W)+Lazertinib+Chemotherapy; Cohort 3b(Exon19del/Exon21 L858R NSCLC, 2L, Post Osimertinib): Amivantamab (Q3W)+Chemotherapy; Cohort 7(Exon19del/Exon21 L858R NSCLC,2L,Post Amivantamab+Lazertinib):Amivantamab(Q3W)+Chemotherapy

Direct Oral Anticoagulant (DOAC) DRUG

DOAC will be administered orally.

Cohort6(Exon19del/Exon21L858R,NSCLC1L,PreviouslyUntreated):Amivantamab(Q2W)+Lazertinib+Anticoagulant

Low Molecular Weight Heparin (LMWH) DRUG

LMWH will be administered subcutaneously.

Cohort6(Exon19del/Exon21L858R,NSCLC1L,PreviouslyUntreated):Amivantamab(Q2W)+Lazertinib+Anticoagulant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Participant has a medical history of interstitial lung disease (ILD), including drug induced ILD or radiation pneumonitis
• Participant has a history of hypersensitivity to any excipients of the investigational products to be used in their enrollment cohort
• For all cohorts (with regimens potentially including lazertinib): Participant is currently receiving medications or herbal supplements known to be potent Cytochrome (CYP3A4/5) inducers and is unable to stop use for an appropriate washout period prior to Cycle 1 Day 1
• Other clinically active liver disease of infectious origin
• Participant has symptomatic brain metastases. A participant with asymptomatic or previously treated and stable brain metastases may participate in this study. Participants who have received definitive radiation or surgical treatment for symptomatic or unstable brain metastases and have been clinically stable and asymptomatic for at least 2 weeks before Screening are eligible, provided they have been either off corticosteroid treatment or are receiving low-dose corticosteroid treatment (less than or equal to \[\<=\] 10 milligrams per day \[mg/day\] prednisone or equivalent) for at least 2 weeks prior to treatment allocation

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (110)

University of California at San Diego

La Jolla, California, 92093, United States

RECRUITING

University of California Irvine

Orange, California, 92868, United States

RECRUITING

Stanford Cancer Institute

Stanford, California, 94305, United States

RECRUITING

Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

RECRUITING

Baptist Lynn Cancer Institute

Boca Raton, Florida, 33486, United States

COMPLETED

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

RECRUITING

AdventHealth

Orlando, Florida, 32804, United States

RECRUITING

H. Lee Moffitt Cancer & Research Institute

Tampa, Florida, 33612, United States

COMPLETED

University of Kansas Cancer Center

Westwood, Kansas, 66205, United States

RECRUITING

Sidney Kimmel Cancer Center - Bayview Campus

Baltimore, Maryland, 21224, United States

RECRUITING

Boston Medical Center

Boston, Massachusetts, 02118, United States

RECRUITING

Washington University School Of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

RECRUITING

Hematology-Oncology Associates of CNY

East Syracuse, New York, 13057, United States

COMPLETED

Novant Health 1

Charlotte, North Carolina, 28204, United States

COMPLETED

Novant Health

Winston-Salem, North Carolina, 27106, United States

COMPLETED

Cleveland Clinic 1

Cleveland, Ohio, 44111, United States

COMPLETED

Cleveland Clinic

Cleveland, Ohio, 44195, United States

COMPLETED

Cleveland Clinic 2

Mayfield Heights, Ohio, 44124, United States

COMPLETED

Cleveland Clinic 3

Warrensville Heights, Ohio, 44122, United States

COMPLETED

The Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

COMPLETED

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

RECRUITING

Providence Regional Cancer Partnership

Everett, Washington, 98201, United States

COMPLETED

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

COMPLETED

Swedish Cancer Institute

Seattle, Washington, 98104, United States

RECRUITING

Fundacao Pio XII

Barretos, 14784-400, Brazil

RECRUITING

PERSONAL Oncologia de Precisao e Personalizada

Belo Horizonte, 30130 090, Brazil

RECRUITING

Instituto do Cancer de Londrina Hospital do Cancer de Londrina

Londrina, 86015, Brazil

RECRUITING

Associacao Hospitalar Moinhos de Vento

Porto Alegre, 90035-001, Brazil

RECRUITING

Instituto D Or de Pesquisa e Ensino IDOR

Rio de Janeiro, 22281 100, Brazil

RECRUITING

Instituto D Or de Pesquisa e Ensino IDOR 1

Salvador, 41253-190, Brazil

RECRUITING

Hospital Alemao Oswaldo Cruz

São Paulo, 01327 001, Brazil

RECRUITING

Impar Servicos Hospitalares SA Hospital Nove de Julho

São Paulo, 01409-001, Brazil

RECRUITING

Fundacao Antonio Prudente A C Camargo Cancer Center

São Paulo, 01509 900, Brazil

RECRUITING

Affiliated Hospital of Hebei University

Baoding, 071051, China

COMPLETED

Jilin cancer hospital

Changchun, 130000, China

RECRUITING

Sichuan Cancer Hospital

Chengdu, 610041, China

RECRUITING

West China Hospital Sichuan University

Chengdu, 610047, China

RECRUITING

The First Affiliated Hospital of PLA Army Medical University

Chongqing, 400038, China

RECRUITING

The First Affiliated Hospital Sun Yat sen University

Guangzhou, 510060, China

RECRUITING

The First Affiliated Hospital Zhejiang University College of Medicine

Hangzhou, 310003, China

RECRUITING

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, 310016, China

RECRUITING

Harbin medical university cancer hospital

Harbin, 150000, China

RECRUITING

Huizhou Municipal Central Hospital

Huizhou, 516001, China

RECRUITING

Liuzhou people's Hospital

Liuchow, 545006, China

COMPLETED

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

RECRUITING

Tianjin Medical University General Hospital

Tianjin, 300052, China

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, 325000, China

RECRUITING

Union Hospital Tongji Medical College of Huazhong University of Science and Technology

Wuhan, 430022, China

RECRUITING

Hospital of Jiangnan University

Wuxi, 214122, China

COMPLETED

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, 710061, China

RECRUITING

Yantai Yuhuangding Hospital

Yantai, 264000, China

COMPLETED

Centre Francois Baclesse

Caen, 14076, France

RECRUITING

Centre Georges-François Leclerc

Dijon, 21079, France

COMPLETED

Institut de Cancérologie du Gard

Nîmes, 30029, France

RECRUITING

Institut Curie

Paris, 75248, France

RECRUITING

Institut de cancerologie de l'ouest

Saint-Herblain, 44805, France

RECRUITING

Gustave Roussy

Villejuif, 94800, France

RECRUITING

Evangelische Lungenklinik Berlin

Berlin, 13125, Germany

COMPLETED

Universitaetsklinikum Koelnt

Cologne, 50937, Germany

RECRUITING

LungenClinic Grosshansdorf GmbH

Grosshandorf, 22927, Germany

RECRUITING

Lungenfachklinik Immenhausen

Immenhausen, 34376, Germany

RECRUITING

Klinikum Würzburg Mitte gGmbH Standort Missioklinik

Würzburg, 97074, Germany

RECRUITING

Rambam Medical Center

Haifa, 3109601, Israel

RECRUITING

Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

RECRUITING

Meir Medical Center

Kfar Saba, 44281, Israel

COMPLETED

Rabin Medical Center

Petah Tikva, 4941492, Israel

RECRUITING

Sheba Medical Center

Ramat Gan, 52621, Israel

RECRUITING

Policlinico Hospital San Martino- IRCCS for Oncology

Genova, 16132, Italy

RECRUITING

Ospedale San Raffaele

Milan, 20132, Italy

RECRUITING

ASST Grande Ospedale Metropolitano Niguarda

Milan, 20162, Italy

RECRUITING

Azienda Ospedaliera San Gerardo

Monza, 20090, Italy

RECRUITING

Azienda Ospedaliera Specialistica dei Colli

Naples, 80131, Italy

RECRUITING

National Hospital Organization Himeji Medical Center

Himeji, 670-8520, Japan

ACTIVE NOT RECRUITING

Saiseikai Matsusaka Municipal Hospital

Matsusaka, 515 8544, Japan

ACTIVE NOT RECRUITING

Niigata Cancer Center Hospital

Niigata, 951-8566, Japan

ACTIVE NOT RECRUITING

Shizuoka Cancer Center

Shizuoka, 411 8777, Japan

ACTIVE NOT RECRUITING

The Cancer Institute Hospital of JFCR

Tokyo, 135 8550, Japan

ACTIVE NOT RECRUITING

Wakayama Medical University Hospital

Wakayama, 641 8510, Japan

ACTIVE NOT RECRUITING

University Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

RECRUITING

Hospital Tengku Ampuan Afzan

Kuantan, 25100, Malaysia

RECRUITING

Hospital Umum Sarawak

Kuching, 93586, Malaysia

RECRUITING

Beacon Hospital Sdn Bhd

Petaling Jaya, 46050, Malaysia

RECRUITING

National Cancer Center

Goyang-si, 10408, South Korea

RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, 13620, South Korea

RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Severance Hospital Yonsei University Health System

Seoul, 03722, South Korea

RECRUITING

Asan Medical Center

Seoul, 05505, South Korea

COMPLETED

Hosp Univ A Coruna

A Coruña, 15006, Spain

RECRUITING

General University Hospital of Alicantet

Alicante, 03010, Spain

RECRUITING

Hosp. Del Mar

Barcelona, 08003, Spain

RECRUITING

Hosp. de La Santa Creu I Sant Pau

Barcelona, 08025, Spain

RECRUITING

Hosp Univ Vall D Hebron

Barcelona, 08035, Spain

RECRUITING

Inst. Cat. Doncologia-H Duran I Reynals

Barcelona, 8908, Spain

RECRUITING

Hosp. Gral. Univ. Gregorio Maranon

Madrid, 28007, Spain

RECRUITING

Hosp. Univ. Ramon Y Cajal

Madrid, 28034, Spain

RECRUITING

Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hosp. Univ. La Paz

Madrid, 28046, Spain

RECRUITING

Hosp Regional Univ de Malaga

Málaga, 29010, Spain

RECRUITING

Hosp. Virgen Macarena

Seville, 41009, Spain

RECRUITING

Hosp. Clinico Univ. de Valencia

Valencia, 46010, Spain

RECRUITING

Hosp. Gral. Univ. Valencia

Valencia, 46014, Spain

RECRUITING

Cheltenham General Hospital

Cheltenham, GL53 7AN, United Kingdom

COMPLETED

Torbay Hospital-Devon

Devon, TQ2 7AA, United Kingdom

RECRUITING

Edinburgh Cancer Centre Western General

Edinburgh, EH4 2XU, United Kingdom

RECRUITING

Leicester Royal Infirmary

Leicester, LE1 5WW, United Kingdom

RECRUITING

University College London Hospitals

London, NW1 2PG, United Kingdom

RECRUITING

Nottingham City Hospital

Nottingham, NG5 1PB, United Kingdom

RECRUITING

Queen Alexandra Hospital

Portsmouth, PO6 3LY, United Kingdom

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

amivantamab; lazertinib; Carboplatin; Pemetrexed; N(4)-oleylcytosine arabinoside; Heparin, Low-Molecular-Weight

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 12, 2022
• Study Start: November 11, 2022
• Primary Completion (Estimated): August 17, 2027
• Study Completion (Estimated): August 18, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (18); BR (9); DE (5); IL (5); IT (5); US (26); JP (6); MY (4); KR (5); ES (14); GB (7); FR (6)