Actively Recruiting
A Phase 2b, Open-Label Study of Amivantamab With Lazertinib or Platinum-Based Chemotherapy for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Led by Janssen Research & Development, LLC · Updated on 2026-06-05
480
Participants Needed
201
Research Sites
83 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the antitumor activity of amivantamab combined with lazertinib or with chemotherapy in participants who have common EGFR-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). This Phase 2b open-label study aims to understand how well these combinations work as first-line or second-line treatments for this type of lung cancer. Participants will be assigned to one of two groups: one group will receive amivantamab combined with lazertinib orally in 28-day cycles, and the other group will receive amivantamab combined with platinum-based chemotherapy (carboplatin and pemetrexed) given by intravenous infusion in 21-day cycles. Treatment will continue until disease progression, withdrawal, death, or investigator decision to stop treatment. During the study, participants will undergo regular assessments including monitoring for progression-free survival up to 4 years and 6 months. Additional evaluations include tracking dose changes, adverse events, overall survival, response rates, and time to treatment discontinuation. Safety and clinical outcomes will be closely observed throughout the treatment period and follow-up.
CONDITIONS
Brief Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer not suitable for curative therapy
- Have an EGFR mutation of Ex19del or Ex21 L858R confirmed by FDA-approved or validated test in a certified laboratory
- Have at least one measurable lesion that has not been previously irradiated
- Any toxicities from prior cancer therapy must be resolved to grade 1 or baseline level except certain specified conditions
- Have an ECOG performance status of 0 to 1
You will not qualify if you...
- Have active interstitial lung disease, including drug-induced ILD or radiation pneumonitis
- Had major surgery or significant injury within 4 weeks before first treatment or plan surgery during study participation
- Have uncontrolled tumor-related pain not treated prior to dosing
- Received investigational treatment not cleared by at least 5 half lives before study treatment or currently in another investigational study
- Have prior or concurrent second malignancy that could interfere with study safety or efficacy endpoints
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Until disease progression or discontinuation
Participants receive Amivantamab in combination with either Lazertinib orally in 28-day cycles or chemotherapy (carboplatin and pemetrexed) intravenous infusion in 21-day cycles until disease progression, withdrawal of consent, death, or the investigator decides to discontinue treatment.
Repeated visits every 21 or 28 days depending on treatment cohort
Trial Site Locations
Total: 201 locations
1
Southern Cancer Center, PC
Daphne, Alabama, United States, 36526
Actively Recruiting
2
Clearview Cancer Institute
Huntsville, Alabama, United States, 35805
Actively Recruiting
3
City of Hope Phoenix
Goodyear, Arizona, United States, 85338
Actively Recruiting
4
The Oncology Institute of Hope and Innovation
Cerritos, California, United States, 90703
Actively Recruiting
5
City of Hope Corona
Corona, California, United States, 92882
Actively Recruiting
6
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
7
Providence Medical Foundation
Fullerton, California, United States, 92835
Actively Recruiting
8
Oncology Physicians Network Healthcare
Glendale, California, United States, 91203
Completed
9
Los Angeles Cancer Network
Glendale, California, United States, 91204
Actively Recruiting
10
Glendale Adventist Medical Center
Glendale, California, United States, 91206
Actively Recruiting
11
Marin Cancer Center
Greenbrae, California, United States, 94904
Actively Recruiting
12
City of Hope Seacliff
Huntington Beach, California, United States, 92648
Actively Recruiting
13
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, United States, 92618
Actively Recruiting
14
University of California San Diego Health
La Jolla, California, United States, 92093
Actively Recruiting
15
City of Hope Antelope Valley
Lancaster, California, United States, 93534
Actively Recruiting
16
City of Hope Long Beach Elm
Long Beach, California, United States, 90813
Actively Recruiting
17
Cancer and Blood Specialty Clinic
Los Alamitos, California, United States, 90720
Actively Recruiting
18
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
19
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
20
Valkyrie Clinical Trials
Los Angeles, California, United States, 90067
Actively Recruiting
21
Valkyrie Clinical Trials Murrieta
Murrieta, California, United States, 92562
Actively Recruiting
22
Kaiser Permanente Oakland Medical Center
Oakland, California, United States, 94611
Actively Recruiting
23
St. Joseph Hospital Center for Cancer Prevention and Treatment
Orange, California, United States, 92868
Actively Recruiting
24
University of California Irvine
Orange, California, United States, 92868
Actively Recruiting
25
Sutter Health Palo Alto Medical Foundation
Palo Alto, California, United States, 94301
Actively Recruiting
26
Kaiser Permanente Roseville Medical Center
Roseville, California, United States, 95661
Actively Recruiting
27
UC Davis Comprehensive Cancer Center
Sacramento, California, United States, 95630
Actively Recruiting
28
Sutter Institute for Medical Research
Sacramento, California, United States, 95816
Actively Recruiting
29
California Pacific Medical Center
San Francisco, California, United States, 94115
Actively Recruiting
30
Kaiser Permanente San Francisco Medical Center
San Francisco, California, United States, 94115
Actively Recruiting
31
UCSF Zuckerberg San Francisco General Hospital
San Francisco, California, United States, 94143
Actively Recruiting
32
Sansum Clinic
Santa Barbara, California, United States, 93105
Actively Recruiting
33
Kaiser Permanente Santa Clara Medical Center
Santa Clara, California, United States, 95051
Actively Recruiting
34
Providence Medical Foundation 1
Santa Rosa, California, United States, 95403
Actively Recruiting
35
City of Hope South Pasadena
South Pasadena, California, United States, 91030
Actively Recruiting
36
City of Hope Upland
Upland, California, United States, 91786
Actively Recruiting
37
Kaiser Permanente Northern California
Vallejo, California, United States, 94589
Actively Recruiting
38
Kaiser Permanente Walnut Creek Medical Center
Walnut Creek, California, United States, 94596
Actively Recruiting
39
John Muir Health Clinical Research Center
Walnut Creek, California, United States, 94598
Actively Recruiting
40
National Jewish Health
Denver, Colorado, United States, 80206
Completed
41
Saint Josephs Hospital Cancer Centers of Colorado
Denver, Colorado, United States, 80218
Completed
42
Lutheran Hospital Cancer Centers of Colorado
Golden, Colorado, United States, 80401
Completed
43
Rocky Mountain Cancer Centers
Lone Tree, Colorado, United States, 80124
Actively Recruiting
44
Yale New Haven Hospital Yale Cancer Center
New Haven, Connecticut, United States, 06520
Actively Recruiting
45
ChristianaCare Helen F Graham Cancer Center and Research Institute
Newark, Delaware, United States, 19713
Actively Recruiting
46
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
47
Washington DC VA Medical Center
Washington D.C., District of Columbia, United States, 20422
Actively Recruiting
48
Baptist Lynn Cancer Institute
Boca Raton, Florida, United States, 33486
Actively Recruiting
49
The Oncology Institute of Hope and Innovation 1
Fort Lauderdale, Florida, United States, 33316
Actively Recruiting
50
Florida Cancer Specialists
Fort Myers, Florida, United States, 33916
Actively Recruiting
51
Univ of Florida
Gainesville, Florida, United States, 32610
Actively Recruiting
52
Memorial Regional Hospital
Hollywood, Florida, United States, 33021 5421
Actively Recruiting
53
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States, 32207
Actively Recruiting
54
Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
55
Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
56
Baptist Health Miami Cancer Institute
Miami, Florida, United States, 33176
Actively Recruiting
57
AdventHealth Orlando
Orlando, Florida, United States, 32803
Actively Recruiting
58
Orlando Health Cancer Institute
Orlando, Florida, United States, 32806
Actively Recruiting
59
Memorial Cancer Institute
Pembroke Pines, Florida, United States, 33026
Actively Recruiting
60
Florida Cancer Specialists & Research Institute 1
St. Petersburg, Florida, United States, 33701
Actively Recruiting
61
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
62
Florida Cancer Specialists & Research Institute
West Palm Beach, Florida, United States, 33401
Actively Recruiting
63
University Cancer And Blood Center LLC
Athens, Georgia, United States, 30607
Actively Recruiting
64
Grady Health System Correll Pavilion
Atlanta, Georgia, United States, 30303
Actively Recruiting
65
Piedmont Healthcare
Atlanta, Georgia, United States, 30309
Actively Recruiting
66
Piedmont Cancer Institute
Atlanta, Georgia, United States, 30318
Actively Recruiting
67
Winship Cancer Institute Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
68
City of Hope Cancer Center
Newnan, Georgia, United States, 30265
Actively Recruiting
69
Rush University Medical Center Rush University Cancer Center Chicago
Chicago, Illinois, United States, 60607
Actively Recruiting
70
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Actively Recruiting
71
Cancer Care Specialists of Central Illinois
Decatur, Illinois, United States, 62526
Actively Recruiting
72
Hope and Healing Cancer Services
Hinsdale, Illinois, United States, 60521
Completed
73
Illinois Cancer Specialists
Niles, Illinois, United States, 60714
Actively Recruiting
74
Illinois CancerCare
Peoria, Illinois, United States, 61615
Actively Recruiting
75
City of Hope Chicago
Zion, Illinois, United States, 60099
Actively Recruiting
76
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States, 46804
Actively Recruiting
77
Investigative Clinical Research of Indiana, LLC
Noblesville, Indiana, United States, 46062
Actively Recruiting
78
Accellacare of McFarland
Ames, Iowa, United States, 50010
Actively Recruiting
79
University of Kansas Cancer Center
Fairway, Kansas, United States, 66205
Actively Recruiting
80
University of Maryland
Baltimore, Maryland, United States, 21201
Actively Recruiting
81
Maryland Oncology Hematology P A
Silver Spring, Maryland, United States, 20904
Actively Recruiting
82
Boston University Medical Center
Boston, Massachusetts, United States, 02118
Actively Recruiting
83
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
84
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
85
University of Michigan Health System
Ann Arbor, Michigan, United States, 48105
Actively Recruiting
86
Trinity Health St Joseph Mercy Ann Arbor
Ypsilanti, Michigan, United States, 48197
Actively Recruiting
87
University Of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
88
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
89
Jackson Oncology Associates
Jackson, Mississippi, United States, 39202
Completed
90
Truman Medical Ctr West
Kansas City, Missouri, United States, 64108
Actively Recruiting
91
Oncology Hematology Associates
Springfield, Missouri, United States, 65807
Actively Recruiting
92
Washington University School Of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
93
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
94
Hunterdon Hematology Oncology
Flemington, New Jersey, United States, 08822
Completed
95
Morristown Medical Center
Morristown, New Jersey, United States, 07960
Actively Recruiting
96
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
97
Overlook Medical Center
Summit, New Jersey, United States, 07901
Actively Recruiting
98
Holy Name Medical Center
Teaneck, New Jersey, United States, 07666
Completed
99
University of New Mexico
Albuquerque, New Mexico, United States, 87102
Actively Recruiting
100
Hematology-Oncology Associates of CNY
East Syracuse, New York, United States, 13057
Actively Recruiting
101
Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, United States, 11501
Actively Recruiting
102
NYU Langone Health Laura and Isaac Perlmutter Cancer Center
New York, New York, United States, 10016
Actively Recruiting
103
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
104
Ellis Hospital
Schenectady, New York, United States, 12308
Actively Recruiting
105
New York Cancer and Blood Specialists
Shirley, New York, United States, 11967
Actively Recruiting
106
Montefiore Medical Center
The Bronx, New York, United States, 10461
Actively Recruiting
107
Clinical Research Alliance Inc
Westbury, New York, United States, 11590
Completed
108
Atrium Health
Charlotte, North Carolina, United States, 28204
Actively Recruiting
109
Duke University Medical Center
Durham, North Carolina, United States, 27710
Completed
110
Regional Medical Oncology Center
Wilson, North Carolina, United States, 27893
Actively Recruiting
111
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
112
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Completed
113
Cincinnati Veterans Affairs Medical Center
Cincinnati, Ohio, United States, 45220
Actively Recruiting
114
Oncology Associates of Oregon PC Willamette Valley Cancer Institute
Eugene, Oregon, United States, 97401
Actively Recruiting
115
Oregon Health And Science University
Portland, Oregon, United States, 97239
Actively Recruiting
116
Lankenau Institute for Medical Research Main Line Health Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
Completed
117
Lankenau Institute for Medical Research Main Line Health Paoli Hospital
Paoli, Pennsylvania, United States, 19301
Completed
118
Philadelphia VA Medical Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
119
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
120
Jefferson Health Northeast
Philadelphia, Pennsylvania, United States, 19114
Actively Recruiting
121
McGlinn Cancer Institute Reading Hospital
West Reading, Pennsylvania, United States, 19611
Actively Recruiting
122
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, United States, 19096
Completed
123
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
124
Avera Medical Group
Sioux Falls, South Dakota, United States, 57105
Completed
125
Tennessee Oncology - Chattanooga
Chattanooga, Tennessee, United States, 37404
Actively Recruiting
126
Tennessee Cancer Specialists
Knoxville, Tennessee, United States, 37909
Actively Recruiting
127
University of Tennessee
Knoxville, Tennessee, United States, 37920
Actively Recruiting
128
Baptist Cancer Center
Memphis, Tennessee, United States, 38120
Completed
129
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
130
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Actively Recruiting
131
Texas Oncology South
Austin, Texas, United States, 78745
Actively Recruiting
132
Parkland Health and Hospital System
Dallas, Texas, United States, 75235
Actively Recruiting
133
Texas Oncology DFW
Dallas, Texas, United States, 75246
Actively Recruiting
134
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
135
Renovatio Clinical
El Paso, Texas, United States, 79915
Completed
136
JPS Health Network
Fort Worth, Texas, United States, 76104
Actively Recruiting
137
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
138
Oncology Consultants Texas
Houston, Texas, United States, 77030
Actively Recruiting
139
Community Clinical Trials
Kingwood, Texas, United States, 77339
Actively Recruiting
140
Texas Oncology Odessa-West Texas Cancer Center
Odessa, Texas, United States, 79761
Completed
141
Texas Oncology San Antonio Northeast
San Antonio, Texas, United States, 78217
Actively Recruiting
142
Renovatio Clinical 1
The Woodlands, Texas, United States, 77380
Completed
143
The University of Texas Health Science Center at Tyler
Tyler, Texas, United States, 75701
Actively Recruiting
144
Texas Oncology - Northeast
Tyler, Texas, United States, 75702
Actively Recruiting
145
Texas Oncology-Gulf Coast
Webster, Texas, United States, 77598
Actively Recruiting
146
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Actively Recruiting
147
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
148
Vista Oncology
Olympia, Washington, United States, 98506
Actively Recruiting
149
Summit Cancer Centers
Spokane, Washington, United States, 99208
Actively Recruiting
150
Northwest Cancer Specialists - Vancouver
Vancouver, Washington, United States, 98684
Completed
151
Ziekenhuis Oost-Limburg
Genk, Belgium, 3600
Actively Recruiting
152
Ghent University Hospital
Ghent, Belgium, 9000
Actively Recruiting
153
Universitair Ziekenhuis Leuven
Leuven, Belgium, 3000
Actively Recruiting
154
CHU UCL Namur - Site Godinne
Yvoir, Belgium, 5530
Actively Recruiting
155
Helsinki University Hospital
Helsinki, Finland, 00290
Actively Recruiting
156
Oulu University Hospital
Oulu, Finland, 90220
Actively Recruiting
157
Turku University Hospital
Turku, Finland, 20521
Actively Recruiting
158
CHU de Brest - Hopital de la Cavale Blanche
Brest, France, 29200
Actively Recruiting
159
CHU de Grenoble
La Tronche, France, 38700
Actively Recruiting
160
Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital
Marseille, France, 13005
Actively Recruiting
161
I.C.O. Rene Gauducheau
Saint-Herblain, France, 44805
Actively Recruiting
162
St. Elisabeth Hospital Leipzig
Leipzig, Germany, 04277
Actively Recruiting
163
Klinikum der Universitaet Muenchen
München, Germany, 80336
Actively Recruiting
164
Katharinenhospital Innere Medizin
Stuttgart, Germany, 70174
Actively Recruiting
165
Henry Dunant Hospital Center
Athens, Greece, 115 26
Actively Recruiting
166
Thoracic General Hospital Of Athens I Sotiria
Athens, Greece, 11527
Actively Recruiting
167
Metaxa Cancer Center Hospital Of Piraeus
Piraeus, Greece, 18537
Actively Recruiting
168
Anticancer Hospital of Thessaloniki Theageneio
Thessaloniki, Greece, 546 39
Actively Recruiting
169
Athens Medical Center S A Interbalkan Medical Center of Thessaloniki
Thessaloniki, Greece, 54639
Actively Recruiting
170
Soroka Medical Center
Beersheba, Israel, 8457108
Actively Recruiting
171
Rambam Medical Center
Haifa, Israel, 3109601
Actively Recruiting
172
Meir Medical Center
Kfar Saba, Israel, 44281
Actively Recruiting
173
Sheba Medical Center
Ramat Gan, Israel, 5262000
Actively Recruiting
174
Aou San Luigi Gonzaga
Orbassano, Italy, 10043
Actively Recruiting
175
Istituto Oncologico Veneto - IRCCS
Padova, Italy, 35128
Actively Recruiting
176
Ospedale S. Maria Delle Croci
Ravenna, Italy, 48121
Actively Recruiting
177
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, Italy, 00168
Actively Recruiting
178
Istituto Clinico Humanitas
Rozzano, Italy, 20089
Actively Recruiting
179
Centrum Onkologii im Prof F Lukaszczyka
Bydgoszcz, Poland, 85 796
Actively Recruiting
180
Centrum Pulmonologii i Torakochirurgii w Bystrej
Bystra, Poland, 43 360
Actively Recruiting
181
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80 952
Actively Recruiting
182
Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie
Olsztyn, Poland, 10-357
Actively Recruiting
183
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warsaw, Poland, 02-781
Actively Recruiting
184
Uls Braga - Hosp. Braga
Braga, Portugal, 4710 243
Actively Recruiting
185
Uls Alto Ave - Hosp. Sra. Da Oliveira Guimaraes
Guimarães, Portugal, 4835 044
Actively Recruiting
186
Hosp. Cuf Tejo
Lisbon, Portugal, 1350-352
Actively Recruiting
187
Uls Loures Odivelas - Hosp. Loures
Loures, Portugal, 2674 514
Actively Recruiting
188
Ipo Porto
Porto, Portugal, 4200 072
Actively Recruiting
189
Uls Gaia Espinho
Vila Nova de Gaia, Portugal, 4434 502
Actively Recruiting
190
Auxilio Mutuo Cancer Center
San Juan, Puerto Rico, 00918
Actively Recruiting
191
Hosp Univ Vall D Hebron
Barcelona, Spain, 08035
Actively Recruiting
192
Hosp. de Jerez de La Frontera
Jerez de la Frontera, Spain, 11407
Actively Recruiting
193
Hosp. Univ. 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
194
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, Spain, 15706
Actively Recruiting
195
Hosp. Univ. I Politecni La Fe
Valencia, Spain, 46026
Actively Recruiting
196
Guy's and St Thomas' NHS Foundation Trust
Greater London, United Kingdom, SE1 9RT
Actively Recruiting
197
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, United Kingdom, L78YA
Actively Recruiting
198
Royal Marsden Hospital 1
London, United Kingdom, SW3 6JJ
Actively Recruiting
199
The Christie NHS Foundation Trust Christie Hospital
Manchester, United Kingdom, M20 4BX
Actively Recruiting
200
Royal Marsden Hospital
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
201
Torbay Hospital-Devon
Torquay, United Kingdom, TQ2 7AA
Actively Recruiting
Research Team
S
Study Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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