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
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
2 other identifiers
interventional
480
13 countries
196
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2024
Longer than P75 for phase_2
196 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2024
CompletedFirst Posted
Study publicly available on registry
October 31, 2024
CompletedStudy Start
First participant enrolled
December 16, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 23, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 26, 2030
April 13, 2026
April 1, 2026
4.4 years
October 30, 2024
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
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 Outcomes (11)
Number of Participants Reporting Dose Reductions, Interruptions, and Discontinuations
Up to 4 Years and 6 months
Number of Participants With Venous Thromboembolic Events (VTEs)
Up to 4 Years and 6 months
Number of Participants With Dermatologic Adverse Events (AEs)
Up to 4 Years and 6 months
Number of Participants with AEs by Severity
Up to 4 Years and 6 months
Overall Survival (OS)
Up to 4 Years and 6 months
- +6 more secondary outcomes
Study Arms (2)
Cohort 1: Amivantamab and Lazertinib
EXPERIMENTALParticipants 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.
Cohort 2: Amivantamab and Chemotherapy
EXPERIMENTALParticipants 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.
Interventions
Amivantamab will be administered.
Lazertinib tablet will be administered.
Carboplatin will be administered.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (196)
Southern Cancer Center, PC
Daphne, Alabama, 36526, United States
Clearview Cancer Institute
Huntsville, Alabama, 35805, United States
City of Hope Phoenix
Goodyear, Arizona, 85338, United States
The Oncology Institute of Hope and Innovation
Cerritos, California, 90703, United States
City of Hope Corona
Corona, California, 92882, United States
City of Hope
Duarte, California, 91010, United States
Providence Medical Foundation
Fullerton, California, 92835, United States
Oncology Physicians Network Healthcare
Glendale, California, 91203, United States
Los Angeles Cancer Network
Glendale, California, 91204, United States
Glendale Adventist Medical Center
Glendale, California, 91206, United States
Marin Cancer Center
Greenbrae, California, 94904, United States
City of Hope Seacliff
Huntington Beach, California, 92648, United States
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, 92618, United States
University of California San Diego Health
La Jolla, California, 92093, United States
City of Hope Antelope Valley
Lancaster, California, 93534, United States
City of Hope Long Beach Elm
Long Beach, California, 90813, United States
Cancer and Blood Specialty Clinic
Los Alamitos, California, 90720, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
Valkyrie Clinical Trials
Los Angeles, California, 90067, United States
Valkyrie Clinical Trials Murrieta
Murrieta, California, 92562, United States
Kaiser Permanente Oakland Medical Center
Oakland, California, 94611, United States
St. Joseph Hospital Center for Cancer Prevention and Treatment
Orange, California, 92868, United States
University of California Irvine
Orange, California, 92868, United States
Sutter Health Palo Alto Medical Foundation
Palo Alto, California, 94301, United States
Kaiser Permanente Roseville Medical Center
Roseville, California, 95661, United States
UC Davis Comprehensive Cancer Center
Sacramento, California, 95630, United States
Sutter Institute for Medical Research
Sacramento, California, 95816, United States
California Pacific Medical Center
San Francisco, California, 94115, United States
Kaiser Permanente San Francisco Medical Center
San Francisco, California, 94115, United States
UCSF Zuckerberg San Francisco General Hospital
San Francisco, California, 94143, United States
Sansum Clinic
Santa Barbara, California, 93105, United States
Kaiser Permanente Santa Clara Medical Center
Santa Clara, California, 95051, United States
Providence Medical Foundation 1
Santa Rosa, California, 95403, United States
City of Hope South Pasadena
South Pasadena, California, 91030, United States
City of Hope Upland
Upland, California, 91786, United States
Kaiser Permanente Northern California
Vallejo, California, 94589, United States
Kaiser Permanente Walnut Creek Medical Center
Walnut Creek, California, 94596, United States
John Muir Health Clinical Research Center
Walnut Creek, California, 94598, United States
National Jewish Health
Denver, Colorado, 80206, United States
Saint Josephs Hospital Cancer Centers of Colorado
Denver, Colorado, 80218, United States
Lutheran Hospital Cancer Centers of Colorado
Golden, Colorado, 80401, United States
Rocky Mountain Cancer Centers
Lone Tree, Colorado, 80124, United States
Yale New Haven Hospital Yale Cancer Center
New Haven, Connecticut, 06520, United States
ChristianaCare Helen F Graham Cancer Center and Research Institute
Newark, Delaware, 19713, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Washington DC VA Medical Center
Washington D.C., District of Columbia, 20422, United States
Baptist Lynn Cancer Institute
Boca Raton, Florida, 33486, United States
The Oncology Institute of Hope and Innovation 1
Fort Lauderdale, Florida, 33316, United States
Florida Cancer Specialists
Fort Myers, Florida, 33916, United States
Univ of Florida
Gainesville, Florida, 32610, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
Baptist Health Miami Cancer Institute
Miami, Florida, 33176, United States
AdventHealth Orlando
Orlando, Florida, 32803, United States
Orlando Health Cancer Institute
Orlando, Florida, 32806, United States
Florida Cancer Specialists & Research Institute 1
St. Petersburg, Florida, 33701, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Florida Cancer Specialists & Research Institute
West Palm Beach, Florida, 33401, United States
University Cancer And Blood Center LLC
Athens, Georgia, 30607, United States
Grady Health System Correll Pavilion
Atlanta, Georgia, 30303, United States
Piedmont Healthcare
Atlanta, Georgia, 30309, United States
Piedmont Cancer Institute
Atlanta, Georgia, 30318, United States
Winship Cancer Institute Emory University
Atlanta, Georgia, 30322, United States
City of Hope Cancer Center
Newnan, Georgia, 30265, United States
Rush University Medical Center Rush University Cancer Center Chicago
Chicago, Illinois, 60607, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
Cancer Care Specialists of Central Illinois
Decatur, Illinois, 62526, United States
Hope and Healing Cancer Services
Hinsdale, Illinois, 60521, United States
Illinois Cancer Specialists
Niles, Illinois, 60714, United States
Illinois CancerCare
Peoria, Illinois, 61615, United States
City of Hope Chicago
Zion, Illinois, 60099, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46804, United States
Investigative Clinical Research of Indiana, LLC
Noblesville, Indiana, 46062, United States
Accellacare of McFarland
Ames, Iowa, 50010, United States
University of Kansas Cancer Center
Fairway, Kansas, 66205, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Maryland Oncology Hematology P A
Silver Spring, Maryland, 20904, United States
Boston University Medical Center
Boston, Massachusetts, 02118, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
University of Michigan Health System
Ann Arbor, Michigan, 48105, United States
Trinity Health St Joseph Mercy Ann Arbor
Ypsilanti, Michigan, 48197, United States
University Of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Jackson Oncology Associates
Jackson, Mississippi, 39202, United States
Truman Medical Ctr West
Kansas City, Missouri, 64108, United States
Oncology Hematology Associates
Springfield, Missouri, 65807, United States
Washington University School Of Medicine
St Louis, Missouri, 63110, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Hunterdon Hematology Oncology
Flemington, New Jersey, 08822, United States
Morristown Medical Center
Morristown, New Jersey, 07960, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901, United States
Overlook Medical Center
Summit, New Jersey, 07901, United States
Holy Name Medical Center
Teaneck, New Jersey, 07666, United States
University of New Mexico
Albuquerque, New Mexico, 87102, United States
Hematology-Oncology Associates of CNY
East Syracuse, New York, 13057, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, 11501, United States
NYU Langone Health Laura and Isaac Perlmutter Cancer Center
New York, New York, 10016, United States
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
New York, New York, 10032, United States
Ellis Hospital
Schenectady, New York, 12308, United States
New York Cancer and Blood Specialists
Shirley, New York, 11967, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Clinical Research Alliance Inc
Westbury, New York, 11590, United States
Atrium Health
Charlotte, North Carolina, 28204, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Regional Medical Oncology Center
Wilson, North Carolina, 27893, United States
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157, United States
University of Cincinnati
Cincinnati, Ohio, 45219, United States
Cincinnati Veterans Affairs Medical Center
Cincinnati, Ohio, 45220, United States
Oncology Associates of Oregon PC Willamette Valley Cancer Institute
Eugene, Oregon, 97401, United States
Oregon Health And Science University
Portland, Oregon, 97239, United States
Lankenau Institute for Medical Research Main Line Health Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010, United States
Lankenau Institute for Medical Research Main Line Health Paoli Hospital
Paoli, Pennsylvania, 19301, United States
Philadelphia VA Medical Center
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Jefferson Health Northeast
Philadelphia, Pennsylvania, 19114, United States
McGlinn Cancer Institute Reading Hospital
West Reading, Pennsylvania, 19611, United States
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, 19096, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Avera Medical Group
Sioux Falls, South Dakota, 57105, United States
Tennessee Oncology - Chattanooga
Chattanooga, Tennessee, 37404, United States
Tennessee Cancer Specialists
Knoxville, Tennessee, 37909, United States
University of Tennessee
Knoxville, Tennessee, 37920, United States
Baptist Cancer Center
Memphis, Tennessee, 38120, United States
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
Tennessee Oncology
Nashville, Tennessee, 37203, United States
Texas Oncology South
Austin, Texas, 78745, United States
Parkland Health and Hospital System
Dallas, Texas, 75235, United States
Texas Oncology DFW
Dallas, Texas, 75246, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Renovatio Clinical
El Paso, Texas, 79915, United States
JPS Health Network
Fort Worth, Texas, 76104, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Oncology Consultants Texas
Houston, Texas, 77030, United States
Community Clinical Trials
Kingwood, Texas, 77339, United States
Texas Oncology Odessa-West Texas Cancer Center
Odessa, Texas, 79761, United States
Texas Oncology San Antonio Northeast
San Antonio, Texas, 78217, United States
Renovatio Clinical 1
The Woodlands, Texas, 77380, United States
The University of Texas Health Science Center at Tyler
Tyler, Texas, 75701, United States
Texas Oncology - Northeast
Tyler, Texas, 75702, United States
Texas Oncology-Gulf Coast
Webster, Texas, 77598, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
Vista Oncology
Olympia, Washington, 98506, United States
Summit Cancer Centers
Spokane, Washington, 99208, United States
Northwest Cancer Specialists - Vancouver
Vancouver, Washington, 98684, United States
Ziekenhuis Oost-Limburg
Genk, 3600, Belgium
Ghent University Hospital
Ghent, 9000, Belgium
Universitair Ziekenhuis Leuven
Leuven, 3000, Belgium
CHU UCL Namur - Site Godinne
Yvoir, 5530, Belgium
Helsinki University Hospital
Helsinki, 00290, Finland
Oulu University Hospital
Oulu, 90220, Finland
Turku University Hospital
Turku, 20521, Finland
CHU de Brest - Hopital de la Cavale Blanche
Brest, 29200, France
CHU de Grenoble
La Tronche, 38700, France
Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital
Marseille, 13005, France
I.C.O. Rene Gauducheau
Saint-Herblain, 44805, France
St. Elisabeth Hospital Leipzig
Leipzig, 04277, Germany
Klinikum der Universitaet Muenchen
München, 80336, Germany
Henry Dunant Hospital Center
Athens, 115 26, Greece
Thoracic General Hospital Of Athens I Sotiria
Athens, 11527, Greece
Metaxa Cancer Center Hospital Of Piraeus
Piraeus, 18537, Greece
Anticancer Hospital of Thessaloniki Theageneio
Thessaloniki, 546 39, Greece
Athens Medical Center S A Interbalkan Medical Center of Thessaloniki
Thessaloniki, 54639, Greece
Soroka Medical Center
Beersheba, 8457108, Israel
Rambam Medical Center
Haifa, 3109601, Israel
Meir Medical Center
Kfar Saba, 44281, Israel
Sheba Medical Center
Ramat Gan, 5262000, Israel
Istituto Oncologico Veneto - IRCCS
Padova, 35128, Italy
Ospedale S. Maria Delle Croci
Ravenna, 48121, Italy
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, 00168, Italy
Istituto Clinico Humanitas
Rozzano, 20089, Italy
Centrum Onkologii im Prof F Lukaszczyka
Bydgoszcz, 85 796, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, 80 952, Poland
Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie
Olsztyn, 10-357, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warsaw, 02-781, Poland
Uls Braga - Hosp. Braga
Braga, 4710 243, Portugal
Uls Alto Ave - Hosp. Sra. Da Oliveira Guimaraes
Guimarães, 4835 044, Portugal
Hosp. Cuf Tejo
Lisbon, 1350-352, Portugal
Uls Loures Odivelas - Hosp. Loures
Loures, 2674 514, Portugal
Ipo Porto
Porto, 4200 072, Portugal
Uls Gaia Espinho
Vila Nova de Gaia, 4434 502, Portugal
Auxilio Mutuo Cancer Center
San Juan, 00918, Puerto Rico
Hosp Univ Vall D Hebron
Barcelona, 08035, Spain
Hosp. de Jerez de La Frontera
Jerez de la Frontera, 11407, Spain
Hosp. Univ. 12 de Octubre
Madrid, 28041, Spain
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, 15706, Spain
Hosp. Univ. I Politecni La Fe
Valencia, 46026, Spain
Guy's and St Thomas' NHS Foundation Trust
Greater London, SE1 9RT, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, L78YA, United Kingdom
Royal Marsden Hospital 1
London, SW3 6JJ, United Kingdom
The Christie NHS Foundation Trust Christie Hospital
Manchester, M20 4BX, United Kingdom
Royal Marsden Hospital
Sutton, SM2 5PT, United Kingdom
Torbay Hospital-Devon
Torquay, TQ2 7AA, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Central Study Contacts
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
October 30, 2024
First Posted
October 31, 2024
Study Start
December 16, 2024
Primary Completion (Estimated)
May 23, 2029
Study Completion (Estimated)
December 26, 2030
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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.