A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) (COPERNICUS)

May 7, 2026 updated by: Janssen Research & Development, LLC

A Phase 2b, Open-Label, Two-cohort Study of Subcutaneous Amivantamab in Combination With Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination With Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

The primary purpose of the study is to assess how well amivantamab in combination with lazertinib or in combination with chemotherapy works (antitumor activity) in participants with epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC; that is one of the major types of lung cancer).

Study Overview

Status

Recruiting

Conditions

Carcinoma, Non-Small-Cell Lung

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

480

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Study Contact
Phone Number: 844-434-4210
Email: Participate-In-This-Study1@its.jnj.com

Study Locations

Belgium
- - Genk, Belgium, 3600
    - Recruiting
    - Ziekenhuis Oost-Limburg
  - Ghent, Belgium, 9000
    - Recruiting
    - Ghent University Hospital
  - Leuven, Belgium, 3000
    - Recruiting
    - Universitair Ziekenhuis Leuven
  - Yvoir, Belgium, 5530
    - Recruiting
    - CHU UCL Namur - Site Godinne
Finland
- - Helsinki, Finland, 00290
    - Recruiting
    - Helsinki University Hospital
  - Oulu, Finland, 90220
    - Recruiting
    - Oulu University Hospital
  - Turku, Finland, 20521
    - Recruiting
    - Turku University Hospital
France
- - Brest, France, 29200
    - Recruiting
    - Chu de Brest - Hopital de La Cavale Blanche
  - La Tronche, France, 38700
    - Recruiting
    - CHU de Grenoble
  - Marseille, France, 13005
    - Recruiting
    - Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital
  - Saint-Herblain, France, 44805
    - Recruiting
    - I.C.O. Rene Gauducheau
Germany
- - Leipzig, Germany, 04277
    - Recruiting
    - St. Elisabeth Hospital Leipzig
  - München, Germany, 80336
    - Recruiting
    - Klinikum der Universitaet Muenchen
Greece
- - Athens, Greece, 115 26
    - Recruiting
    - Henry Dunant Hospital Center
  - Athens, Greece, 11527
    - Recruiting
    - Thoracic General Hospital of Athens I Sotiria
  - Piraeus, Greece, 18537
    - Recruiting
    - Metaxa Cancer Center Hospital Of Piraeus
  - Thessaloniki, Greece, 546 39
    - Recruiting
    - Anticancer Hospital of Thessaloniki Theageneio
  - Thessaloniki, Greece, 54639
    - Recruiting
    - Athens Medical Center S A Interbalkan Medical Center of Thessaloniki
Israel
- - Beersheba, Israel, 8457108
    - Recruiting
    - Soroka Medical Center
  - Haifa, Israel, 3109601
    - Recruiting
    - Rambam Medical Center
  - Kfar Saba, Israel, 44281
    - Recruiting
    - Meir Medical Center
  - Ramat Gan, Israel, 5262000
    - Recruiting
    - Sheba Medical Center
Italy
- - Orbassano, Italy, 10043
    - Recruiting
    - AOU San Luigi Gonzaga
  - Padova, Italy, 35128
    - Recruiting
    - Istituto Oncologico Veneto - IRCCS
  - Ravenna, Italy, 48121
    - Recruiting
    - Ospedale S. Maria Delle Croci
  - Roma, Italy, 00168
    - Recruiting
    - Fondazione Policlinico Universitario A Gemelli IRCCS
  - Rozzano, Italy, 20089
    - Recruiting
    - Istituto Clinico Humanitas
Poland
- - Bydgoszcz, Poland, 85 796
    - Recruiting
    - Centrum Onkologii im Prof F Lukaszczyka
  - Bystra, Poland, 43 360
    - Recruiting
    - Centrum Pulmonologii i Torakochirurgii w Bystrej
  - Gdansk, Poland, 80 952
    - Recruiting
    - Uniwersyteckie Centrum Kliniczne
  - Olsztyn, Poland, 10-357
    - Recruiting
    - Warminsko-mazurskie Centrum Chorob Pluc w Olsztynie
  - Warsaw, Poland, 02-781
    - Recruiting
    - Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Portugal
- - Braga, Portugal, 4710 243
    - Recruiting
    - Uls Braga - Hosp. Braga
  - Guimarães, Portugal, 4835 044
    - Recruiting
    - Uls Alto Ave - Hosp. Sra. Da Oliveira Guimaraes
  - Lisbon, Portugal, 1350-352
    - Recruiting
    - Hosp. Cuf Tejo
  - Loures, Portugal, 2674 514
    - Recruiting
    - Uls Loures Odivelas - Hosp. Loures
  - Porto, Portugal, 4200 072
    - Recruiting
    - IPO Porto
  - Vila Nova de Gaia, Portugal, 4434 502
    - Recruiting
    - Uls Gaia Espinho
Puerto Rico
- - San Juan, Puerto Rico, 00918
    - Recruiting
    - Auxilio Mutuo Cancer Center
Spain
- - Barcelona, Spain, 08035
    - Recruiting
    - Hosp Univ Vall D Hebron
  - Jerez de la Frontera, Spain, 11407
    - Recruiting
    - Hosp. de Jerez de La Frontera
  - Madrid, Spain, 28041
    - Recruiting
    - Hosp. Univ. 12 de Octubre
  - Santiago de Compostela, Spain, 15706
    - Recruiting
    - Hosp. Clinico Univ. de Santiago
  - Valencia, Spain, 46026
    - Recruiting
    - Hosp. Univ. I Politecni La Fe
United Kingdom
- - Greater London, United Kingdom, SE1 9RT
    - Recruiting
    - Guy's and St Thomas' NHS Foundation Trust
  - Liverpool, United Kingdom, L78YA
    - Recruiting
    - The Clatterbridge Cancer Centre NHS Foundation Trust
  - London, United Kingdom, SW3 6JJ
    - Recruiting
    - Royal Marsden Hospital 1
  - Manchester, United Kingdom, M20 4BX
    - Recruiting
    - The Christie NHS Foundation Trust Christie Hospital
  - Sutton, United Kingdom, SM2 5PT
    - Recruiting
    - Royal Marsden Hospital
  - Torquay, United Kingdom, TQ2 7AA
    - Recruiting
    - Torbay Hospital-Devon
United States
- Alabama
  - Daphne, Alabama, United States, 36526
    - Recruiting
    - Southern Cancer Center, PC
  - Huntsville, Alabama, United States, 35805
    - Recruiting
    - Clearview Cancer Institute
- Arizona
  - Goodyear, Arizona, United States, 85338
    - Recruiting
    - City of Hope Phoenix
- California
  - Cerritos, California, United States, 90703
    - Recruiting
    - The Oncology Institute of Hope and Innovation
  - Corona, California, United States, 92882
    - Recruiting
    - City of Hope Corona
  - Duarte, California, United States, 91010
    - Recruiting
    - City of Hope
  - Fullerton, California, United States, 92835
    - Recruiting
    - Providence Medical Foundation
  - Glendale, California, United States, 91206
    - Recruiting
    - Glendale Adventist Medical Center
  - Glendale, California, United States, 91204
    - Recruiting
    - Los Angeles Cancer Network
  - Glendale, California, United States, 91203
    - Completed
    - Oncology Physicians Network Healthcare
  - Greenbrae, California, United States, 94904
    - Recruiting
    - Marin Cancer Center
  - Huntington Beach, California, United States, 92648
    - Recruiting
    - City of Hope Seacliff
  - Irvine, California, United States, 92618
    - Recruiting
    - City of Hope Orange County Lennar Foundation Cancer Center
  - La Jolla, California, United States, 92093
    - Recruiting
    - University of California San Diego Health
  - Lancaster, California, United States, 93534
    - Recruiting
    - City of Hope Antelope Valley
  - Long Beach, California, United States, 90813
    - Recruiting
    - City of Hope Long Beach Elm
  - Los Alamitos, California, United States, 90720
    - Recruiting
    - Cancer and Blood Specialty Clinic
  - Los Angeles, California, United States, 90048
    - Recruiting
    - Cedars Sinai Medical Center
  - Los Angeles, California, United States, 90033
    - Recruiting
    - USC Norris Comprehensive Cancer Center
  - Los Angeles, California, United States, 90067
    - Recruiting
    - Valkyrie Clinical Trials
  - Murrieta, California, United States, 92562
    - Recruiting
    - Valkyrie Clinical Trials Murrieta
  - Oakland, California, United States, 94611
    - Recruiting
    - Kaiser Permanente Oakland Medical Center
  - Orange, California, United States, 92868
    - Recruiting
    - University of California Irvine
  - Orange, California, United States, 92868
    - Recruiting
    - St. Joseph Hospital Center for Cancer Prevention and Treatment
  - Palo Alto, California, United States, 94301
    - Recruiting
    - Sutter Health Palo Alto Medical Foundation
  - Roseville, California, United States, 95661
    - Recruiting
    - Kaiser Permanente Roseville Medical Center
  - Sacramento, California, United States, 95816
    - Recruiting
    - Sutter Institute for Medical Research
  - Sacramento, California, United States, 95630
    - Recruiting
    - UC Davis Comprehensive Cancer Center
  - San Francisco, California, United States, 94115
    - Recruiting
    - California Pacific Medical Center
  - San Francisco, California, United States, 94115
    - Recruiting
    - Kaiser Permanente San Francisco Medical Center
  - San Francisco, California, United States, 94143
    - Recruiting
    - UCSF Zuckerberg San Francisco General Hospital
  - Santa Barbara, California, United States, 93105
    - Recruiting
    - Sansum Clinic
  - Santa Clara, California, United States, 95051
    - Recruiting
    - Kaiser Permanente Santa Clara Medical Center
  - Santa Rosa, California, United States, 95403
    - Recruiting
    - Providence Medical Foundation 1
  - South Pasadena, California, United States, 91030
    - Recruiting
    - City of Hope South Pasadena
  - Upland, California, United States, 91786
    - Recruiting
    - City of Hope Upland
  - Vallejo, California, United States, 94589
    - Recruiting
    - Kaiser Permanente Northern California
  - Walnut Creek, California, United States, 94596
    - Recruiting
    - Kaiser Permanente Walnut Creek Medical Center
  - Walnut Creek, California, United States, 94598
    - Recruiting
    - John Muir Health Clinical Research Center
- Colorado
  - Denver, Colorado, United States, 80206
    - Recruiting
    - National Jewish Health
  - Denver, Colorado, United States, 80218
    - Completed
    - Saint Josephs Hospital Cancer Centers of Colorado
  - Golden, Colorado, United States, 80401
    - Completed
    - Lutheran Hospital Cancer Centers of Colorado
  - Lone Tree, Colorado, United States, 80124
    - Recruiting
    - Rocky Mountain Cancer Centers
- Connecticut
  - New Haven, Connecticut, United States, 06520
    - Recruiting
    - Yale New Haven Hospital Yale Cancer Center
- Delaware
  - Newark, Delaware, United States, 19713
    - Recruiting
    - ChristianaCare Helen F Graham Cancer Center and Research Institute
- District of Columbia
  - Washington D.C., District of Columbia, United States, 20007
    - Recruiting
    - MedStar Georgetown University Hospital
  - Washington D.C., District of Columbia, United States, 20422
    - Recruiting
    - Washington DC VA Medical Center
- Florida
  - Boca Raton, Florida, United States, 33486
    - Recruiting
    - Baptist Lynn Cancer Institute
  - Fort Lauderdale, Florida, United States, 33316
    - Recruiting
    - The Oncology Institute of Hope and Innovation 1
  - Fort Myers, Florida, United States, 33916
    - Recruiting
    - Florida Cancer Specialists
  - Gainesville, Florida, United States, 32610
    - Recruiting
    - Univ of Florida
  - Hollywood, Florida, United States, 33021 5421
    - Recruiting
    - Memorial Regional Hospital
  - Jacksonville, Florida, United States, 32207
    - Recruiting
    - Baptist MD Anderson Cancer Center
  - Jacksonville, Florida, United States, 32224
    - Recruiting
    - Mayo Clinic
  - Miami, Florida, United States, 33136
    - Recruiting
    - Sylvester Comprehensive Cancer Center
  - Miami, Florida, United States, 33176
    - Recruiting
    - Baptist Health Miami Cancer Institute
  - Orlando, Florida, United States, 32803
    - Recruiting
    - AdventHealth Orlando
  - Orlando, Florida, United States, 32806
    - Recruiting
    - Orlando Health Cancer Institute
  - Pembroke Pines, Florida, United States, 33026
    - Recruiting
    - Memorial Cancer Institute
  - St. Petersburg, Florida, United States, 33701
    - Recruiting
    - Florida Cancer Specialists & Research Institute 1
  - Tampa, Florida, United States, 33612
    - Recruiting
    - Moffitt Cancer Center
  - West Palm Beach, Florida, United States, 33401
    - Recruiting
    - Florida Cancer Specialists & Research Institute
- Georgia
  - Athens, Georgia, United States, 30607
    - Recruiting
    - University Cancer and Blood Center LLC
  - Atlanta, Georgia, United States, 30318
    - Recruiting
    - Piedmont Cancer Institute
  - Atlanta, Georgia, United States, 30309
    - Recruiting
    - Piedmont Healthcare
  - Atlanta, Georgia, United States, 30322
    - Recruiting
    - Winship Cancer Institute Emory University
  - Atlanta, Georgia, United States, 30303
    - Recruiting
    - Grady Health System Correll Pavilion
  - Newnan, Georgia, United States, 30265
    - Recruiting
    - City of Hope cancer Center
- Illinois
  - Chicago, Illinois, United States, 60612
    - Recruiting
    - University of Illinois at Chicago
  - Chicago, Illinois, United States, 60607
    - Recruiting
    - Rush University Medical Center Rush University Cancer Center Chicago
  - Decatur, Illinois, United States, 62526
    - Recruiting
    - Cancer Care Specialists of Central Illinois
  - Hinsdale, Illinois, United States, 60521
    - Completed
    - Hope and Healing Cancer Services
  - Niles, Illinois, United States, 60714
    - Recruiting
    - Illinois Cancer Specialists
  - Peoria, Illinois, United States, 61615
    - Recruiting
    - Illinois CancerCare
  - Zion, Illinois, United States, 60099
    - Recruiting
    - City of Hope Chicago
- Indiana
  - Fort Wayne, Indiana, United States, 46804
    - Recruiting
    - Fort Wayne Medical Oncology and Hematology
  - Noblesville, Indiana, United States, 46062
    - Recruiting
    - Investigative Clinical Research of Indiana, LLC
- Iowa
  - Ames, Iowa, United States, 50010
    - Recruiting
    - Accellacare of McFarland
- Kansas
  - Fairway, Kansas, United States, 66205
    - Recruiting
    - University of Kansas Cancer Center
- Maryland
  - Baltimore, Maryland, United States, 21201
    - Recruiting
    - University of Maryland
  - Silver Spring, Maryland, United States, 20904
    - Recruiting
    - Maryland Oncology Hematology P A
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Recruiting
    - Beth Israel Deaconess Medical Center
  - Boston, Massachusetts, United States, 02215
    - Recruiting
    - Dana Farber Cancer Institute
  - Boston, Massachusetts, United States, 02118
    - Recruiting
    - Boston University Medical Center
- Michigan
  - Ann Arbor, Michigan, United States, 48105
    - Recruiting
    - University of Michigan Health System
  - Ypsilanti, Michigan, United States, 48197
    - Recruiting
    - Trinity Health St Joseph Mercy Ann Arbor
- Minnesota
  - Minneapolis, Minnesota, United States, 55455
    - Recruiting
    - University of Minnesota
  - Rochester, Minnesota, United States, 55905
    - Recruiting
    - Mayo Clinic Rochester
- Mississippi
  - Jackson, Mississippi, United States, 39202
    - Recruiting
    - Jackson Oncology Associates
- Missouri
  - Kansas City, Missouri, United States, 64108
    - Recruiting
    - Truman Medical Ctr West
  - Springfield, Missouri, United States, 65807
    - Recruiting
    - Oncology Hematology Associates
  - St Louis, Missouri, United States, 63110
    - Recruiting
    - Washington University School of Medicine
- New Hampshire
  - Lebanon, New Hampshire, United States, 03756
    - Recruiting
    - Dartmouth Hitchcock Medical Center
- New Jersey
  - Flemington, New Jersey, United States, 08822
    - Completed
    - Hunterdon Hematology Oncology
  - Morristown, New Jersey, United States, 07960
    - Recruiting
    - Morristown Medical Center
  - New Brunswick, New Jersey, United States, 08901
    - Recruiting
    - Rutgers Cancer Institute of New Jersey
  - Summit, New Jersey, United States, 07901
    - Recruiting
    - Overlook Medical Center
  - Teaneck, New Jersey, United States, 07666
    - Completed
    - Holy Name Medical Center
- New Mexico
  - Albuquerque, New Mexico, United States, 87102
    - Recruiting
    - University of New Mexico
- New York
  - East Syracuse, New York, United States, 13057
    - Recruiting
    - Hematology-Oncology Associates of CNY
  - Mineola, New York, United States, 11501
    - Recruiting
    - Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island
  - New York, New York, United States, 10016
    - Recruiting
    - NYU Langone Health Laura and Isaac Perlmutter Cancer Center
  - New York, New York, United States, 10032
    - Recruiting
    - Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
  - Schenectady, New York, United States, 12308
    - Recruiting
    - Ellis Hospital
  - Shirley, New York, United States, 11967
    - Recruiting
    - New York Cancer and Blood Specialists
  - The Bronx, New York, United States, 10461
    - Recruiting
    - Montefiore Medical Center
  - Westbury, New York, United States, 11590
    - Completed
    - Clinical Research Alliance Inc
- North Carolina
  - Charlotte, North Carolina, United States, 28204
    - Recruiting
    - Atrium Health
  - Durham, North Carolina, United States, 27710
    - Completed
    - Duke University Medical Center
  - Wilson, North Carolina, United States, 27893
    - Recruiting
    - Regional Medical Oncology Center
  - Winston-Salem, North Carolina, United States, 27157
    - Recruiting
    - Atrium Health Wake Forest Baptist Comprehensive Cancer Center
- Ohio
  - Cincinnati, Ohio, United States, 45219
    - Completed
    - University of Cincinnati
  - Cincinnati, Ohio, United States, 45220
    - Recruiting
    - Cincinnati Veterans Affairs Medical Center
- Oregon
  - Eugene, Oregon, United States, 97401
    - Recruiting
    - Oncology Associates of Oregon PC Willamette Valley Cancer Institute
  - Portland, Oregon, United States, 97239
    - Recruiting
    - Oregon Health and Science University
- Pennsylvania
  - Bryn Mawr, Pennsylvania, United States, 19010
    - Completed
    - Lankenau Institute for Medical Research Main Line Health Bryn Mawr Hospital
  - Paoli, Pennsylvania, United States, 19301
    - Completed
    - Lankenau Institute for Medical Research Main Line Health Paoli Hospital
  - Philadelphia, Pennsylvania, United States, 19107
    - Recruiting
    - Thomas Jefferson University Hospital
  - Philadelphia, Pennsylvania, United States, 19104
    - Recruiting
    - Philadelphia VA Medical Center
  - Philadelphia, Pennsylvania, United States, 19114
    - Recruiting
    - Jefferson Health Northeast
  - West Reading, Pennsylvania, United States, 19611
    - Recruiting
    - McGlinn Cancer Institute Reading Hospital
  - Wynnewood, Pennsylvania, United States, 19096
    - Completed
    - Lankenau Institute for Medical Research
- South Carolina
  - Charleston, South Carolina, United States, 29425
    - Recruiting
    - Medical University of South Carolina
- South Dakota
  - Sioux Falls, South Dakota, United States, 57105
    - Completed
    - Avera Medical Group
- Tennessee
  - Chattanooga, Tennessee, United States, 37404
    - Recruiting
    - Tennessee Oncology - Chattanooga
  - Knoxville, Tennessee, United States, 37920
    - Recruiting
    - University of Tennessee
  - Knoxville, Tennessee, United States, 37909
    - Recruiting
    - Tennessee Cancer Specialists
  - Memphis, Tennessee, United States, 38120
    - Completed
    - Baptist Cancer Center
  - Nashville, Tennessee, United States, 37203
    - Recruiting
    - Tennessee Oncology
  - Nashville, Tennessee, United States, 37203
    - Recruiting
    - SCRI Oncology Partners
- Texas
  - Austin, Texas, United States, 78745
    - Recruiting
    - Texas Oncology South
  - Dallas, Texas, United States, 75390
    - Recruiting
    - UT Southwestern Medical Center
  - Dallas, Texas, United States, 75235
    - Recruiting
    - Parkland Health and Hospital System
  - Dallas, Texas, United States, 75246
    - Recruiting
    - Texas Oncology DFW
  - El Paso, Texas, United States, 79915
    - Completed
    - Renovatio Clinical
  - Fort Worth, Texas, United States, 76104
    - Recruiting
    - JPS Health Network
  - Houston, Texas, United States, 77030
    - Recruiting
    - MD Anderson Cancer Center
  - Houston, Texas, United States, 77030
    - Recruiting
    - Oncology Consultants Texas
  - Kingwood, Texas, United States, 77339
    - Recruiting
    - Community Clinical Trials
  - Odessa, Texas, United States, 79761
    - Completed
    - Texas Oncology Odessa-West Texas Cancer Center
  - San Antonio, Texas, United States, 78217
    - Recruiting
    - Texas Oncology San Antonio Northeast
  - The Woodlands, Texas, United States, 77380
    - Completed
    - Renovatio Clinical 1
  - Tyler, Texas, United States, 75701
    - Recruiting
    - The University of Texas Health Science Center at Tyler
  - Tyler, Texas, United States, 75702
    - Recruiting
    - Texas Oncology - Northeast
  - Webster, Texas, United States, 77598
    - Recruiting
    - Texas Oncology-Gulf Coast
- Utah
  - Salt Lake City, Utah, United States, 84112
    - Recruiting
    - Huntsman Cancer Institute
- Virginia
  - Fairfax, Virginia, United States, 22031
    - Recruiting
    - Virginia Cancer Specialists
- Washington
  - Olympia, Washington, United States, 98506
    - Recruiting
    - Vista Oncology
  - Spokane, Washington, United States, 99208
    - Recruiting
    - Summit Cancer Centers
  - Vancouver, Washington, United States, 98684
    - Completed
    - Northwest Cancer Specialists - Vancouver

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Have histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC) that is not amenable to curative intent therapy
Epidermal growth factor resistance-mutation (EGFRm) must be an Ex19del or Ex21 L858R substitution, as detected by food and drug administration (FDA)-approved or other validated test in a clinical laboratory improvement amendments (CLIA)-certified laboratory (sites in the US), or an accredited local laboratory (sites outside of the US) in accordance with site standard of care. In the European union (EU), the local test must be Conformité Européenne (CE)-marked or an in-house laboratory-developed test from health institutions in the EU in accordance with Article 5(5) of the in vitro diagnostic regulations (IVDR ) 2071/746, as amended
Have at least 1 measurable lesion, according to RECIST version (v)1.1, that has not been previously irradiated
Any toxicities from prior systemic anticancer therapy must have resolved to national cancer institute common terminology criteria for adverse events (NCI-CTCAE) version 5.0 grade 1 or baseline level (except for alopecia [any grade], grade <=2 peripheral neuropathy, or grade <=2 hypothyroidism stable on hormone replacement)
Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1

Exclusion Criteria:

Medical history of active interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis. Participants with medical history of radiation pneumonitis, including radiation pneumonitis which required steroid treatment, should consult with the medical monitor and eligibility be assessed on a case-by-case basis
Had major surgery excluding placement of vascular access or tumor biopsy or had significant traumatic injury within 4 weeks before the first dose of anticancer treatments or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study
Participant has uncontrolled tumor-related pain (symptomatic lesions amenable to palliative radiotherapy should be treated prior to first dosing)
Received an investigational treatment that has not been cleared (based on at least 5 half lives of any pharmaceutical treatment) before the planned first dose of study treatment or is currently enrolled in an investigational study
Has a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment could likely interfere with any study endpoints of safety or the efficacy of the study treatment(s)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: Amivantamab and Lazertinib Participants will receive Amivantamab in combination with Lazertinib orally in 28-day cycles until disease progression, withdrawal of consent, death, or the investigator decides to discontinue treatment, whichever comes first.	Drug: Amivantamab Amivantamab will be administered. Other Names: JNJ-61186372 Drug: Lazertinib Lazertinib tablet will be administered. Other Names: JNJ-73841937
Experimental: Cohort 2: Amivantamab and Chemotherapy Participants will receive Amivantamab in combination with chemotherapy (carboplatin and pemetrexed) intravenous (IV) infusion in 21-day cycles until disease progression, withdrawal of consent, death, or the investigator decides to discontinue treatment, whichever comes first.	Drug: Amivantamab Amivantamab will be administered. Other Names: JNJ-61186372 Drug: Chemotherapy: Pemetrexed Pemetrexed will be administered. Drug: Chemotherapy: Carboplatin Carboplatin will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS) Time Frame: Up to 4 Years and 6 months	PFS is defined as the time from the date of first dose of any study treatment until the date of objective disease progression or death, whichever occurs first according to response evaluation criteria in solid tumors (RECIST) version (v) 1.1 as assessed by the investigator.	Up to 4 Years and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Reporting Dose Reductions, Interruptions, and Discontinuations Time Frame: Up to 4 Years and 6 months	Participants with dose reductions, interruptions, and discontinuations will be reported.	Up to 4 Years and 6 months
Number of Participants With Venous Thromboembolic Events (VTEs) Time Frame: Up to 4 Years and 6 months	Participants with signs and symptoms (dyspnea, tachypnea, upper- or lower-extremity swelling and discoloration) of VTE events, specifically pulmonary embolism, and deep vein thrombosis will be reported as monitored by the investigators.	Up to 4 Years and 6 months
Number of Participants With Dermatologic Adverse Events (AEs) Time Frame: Up to 4 Years and 6 months	Participants with dermatologic AEs will be reported.	Up to 4 Years and 6 months
Number of Participants with AEs by Severity Time Frame: Up to 4 Years and 6 months	Severity of AEs will be graded according to the national cancer institute common terminology criteria for adverse event (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 4 Years and 6 months
Overall Survival (OS) Time Frame: Up to 4 Years and 6 months	OS is defined as the time from the date of first dose of any study treatment until the date of death due to any cause.	Up to 4 Years and 6 months
Overall Response Rate (ORR) Time Frame: Up to 4 Years and 6 months	ORR is defined as the percentage of participants who achieve either a partial response (PR) or complete response (CR) as their best response both confirmed and unconfirmed, as defined using RECIST v1.1.	Up to 4 Years and 6 months
Clinical Benefit Rate (CBR) Time Frame: Up to 4 Years and 6 months	CBR is defined as the percentage of participants achieving CR or PR, both confirmed and unconfirmed, or durable stable disease (SD) of a duration of at least 11 weeks as defined using RECIST v1.1.	Up to 4 Years and 6 months
Duration of Response (DOR) Time Frame: Up to 4 Years and 6 months	DOR is defined as the time from the date of first documented response (PR or CR) until the date of documented progression or death, whichever occurs first, for participants who have PR or CR.	Up to 4 Years and 6 months
Time to Treatment Discontinuation (TTTD) Time Frame: Up to 4 Years and 6 months	TTTD is defined as the date from the date of first dose of any study treatment until discontinuation of study treatment for any reason, including disease progression, treatment toxicity or death, based on RECIST v 1.1.	Up to 4 Years and 6 months
Time to Subsequent Therapy (TTST) Time Frame: Up to 4 Years and 6 months	TTST is defined as the time from the date of first dose of any study treatment until the start date of the subsequent anticancer therapy following study treatment discontinuation or death, whichever occurs first.	Up to 4 Years and 6 months
Time to Symptomatic Progression (TTSP) Time Frame: Up to 4 Years and 6 months	TTSP is defined as the time from date of first dose of any study treatment to documentation in the electronic case report form (eCRF) of any of the following (whichever occurs earlier): onset of new symptoms or symptom worsening that is considered by the investigator to be related to lung cancer and requires either a change in systemic anticancer treatment and/or clinical intervention to manage symptoms or death.	Up to 4 Years and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Investigators

Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2024

Primary Completion (Estimated)

May 23, 2029

Study Completion (Estimated)

December 26, 2030

Study Registration Dates

First Submitted

October 30, 2024

First Submitted That Met QC Criteria

October 30, 2024

First Posted (Actual)

October 31, 2024

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

61186372NSC2012 (Other Identifier: Janssen Research & Development, LLC)
2025-520730-28-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Carcinoma, Non-Small-Cell Lung

Clinical Trials on Amivantamab

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