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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)

RecruitingPhase 2

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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)

About the study

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).

What is being tested

Sponsor: Janssen Research & Development, LLC · Participants: 480 · Started: Dec 16, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06667076

Locations in the U.S.

AlabamaSouthern Cancer Center, PC, Daphne
ArizonaCity of Hope Phoenix, Goodyear
CaliforniaThe Oncology Institute of Hope and Innovation, Cerritos
City of Hope Corona, Corona
City of Hope, Duarte
Providence Medical Foundation, Fullerton
Glendale Adventist Medical Center, Glendale
Los Angeles Cancer Network, Glendale
Marin Cancer Center, Greenbrae
City of Hope Seacliff, Huntington Beach
City of Hope Orange County Lennar Foundation Cancer Center, Irvine
University of California San Diego Health, La Jolla
City of Hope Antelope Valley, Lancaster
City of Hope Long Beach Elm, Long Beach
Cancer and Blood Specialty Clinic, Los Alamitos
Cedars Sinai Medical Center, Los Angeles
USC Norris Comprehensive Cancer Center, Los Angeles
Valkyrie Clinical Trials, Los Angeles
Valkyrie Clinical Trials Murrieta, Murrieta
St. Joseph Hospital Center for Cancer Prevention and Treatment, Orange
University of California Irvine, Orange
UC Davis Comprehensive Cancer Center, Sacramento
UCSF Zuckerberg San Francisco General Hospital, San Francisco
Sansum Clinic, Santa Barbara
Kaiser Permanente Santa Clara Medical Center, Santa Clara
Providence Medical Foundation 1, Santa Rosa
City of Hope South Pasadena, South Pasadena
City of Hope Upland, Upland
Kaiser Permanente Northern California, Vallejo
John Muir Health Clinical Research Center, Walnut Creek
Kaiser Permanente Walnut Creek Medical Center, Walnut Creek
ColoradoRocky Mountain Cancer Centers, Lone Tree
ConnecticutYale New Haven Hospital Yale Cancer Center, New Haven
DelawareChristianaCare Helen F Graham Cancer Center and Research Institute, Newark
District of ColumbiaMedStar Georgetown University Hospital, Washington D.C.
Washington DC VA Medical Center, Washington D.C.
FloridaBaptist Lynn Cancer Institute, Boca Raton
The Oncology Institute of Hope and Innovation 1, Fort Lauderdale
Florida Cancer Specialists, Fort Myers
Univ of Florida, Gainesville
Memorial Regional Hospital, Hollywood
Baptist MD Anderson Cancer Center, Jacksonville
Mayo Clinic, Jacksonville
Baptist Health Miami Cancer Institute, Miami
Sylvester Comprehensive Cancer Center, Miami
AdventHealth Orlando, Orlando
Orlando Health Cancer Institute, Orlando
Memorial Cancer Institute, Pembroke Pines
Florida Cancer Specialists & Research Institute 1, St. Petersburg
Moffitt Cancer Center, Tampa
Florida Cancer Specialists & Research Institute, West Palm Beach
GeorgiaGrady Health System Correll Pavilion, Atlanta
Piedmont Cancer Institute, Atlanta
Piedmont Healthcare, Atlanta
Winship Cancer Institute Emory University, Atlanta
City of Hope Cancer Center, Newnan
IllinoisRush University Medical Center Rush University Cancer Center Chicago, Chicago
University of Illinois at Chicago, Chicago
Cancer Care Specialists of Central Illinois, Decatur
Illinois CancerCare, Peoria
City of Hope Chicago, Zion
IndianaFort Wayne Medical Oncology and Hematology, Fort Wayne
Investigative Clinical Research of Indiana, LLC, Noblesville
IowaAccellacare of McFarland, Ames
KansasUniversity of Kansas Cancer Center, Fairway
MarylandUniversity of Maryland, Baltimore
Maryland Oncology Hematology P A, Silver Spring
MassachusettsBeth Israel Deaconess Medical Center, Boston
Boston University Medical Center, Boston
Dana Farber Cancer Institute, Boston
MichiganUniversity of Michigan Health System, Ann Arbor
Trinity Health St Joseph Mercy Ann Arbor, Ypsilanti
MinnesotaUniversity Of Minnesota, Minneapolis
Mayo Clinic Rochester, Rochester
MissouriTruman Medical Ctr West, Kansas City
Oncology Hematology Associates, Springfield
Washington University School Of Medicine, St Louis
New HampshireDartmouth Hitchcock Medical Center, Lebanon
New JerseyMorristown Medical Center, Morristown
Rutgers Cancer Institute of New Jersey, New Brunswick
Overlook Medical Center, Summit
New MexicoUniversity of New Mexico, Albuquerque
New YorkHematology-Oncology Associates of CNY, East Syracuse
Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island, Mineola
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center, New York
NYU Langone Health Laura and Isaac Perlmutter Cancer Center, New York
Ellis Hospital, Schenectady
New York Cancer and Blood Specialists, Shirley
Montefiore Medical Center, The Bronx
North CarolinaAtrium Health, Charlotte
Regional Medical Oncology Center, Wilson
Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem
OhioCincinnati Veterans Affairs Medical Center, Cincinnati
OregonOncology Associates of Oregon PC Willamette Valley Cancer Institute, Eugene
Oregon Health And Science University, Portland
PennsylvaniaJefferson Health Northeast, Philadelphia
Thomas Jefferson University Hospital, Philadelphia
McGlinn Cancer Institute Reading Hospital, West Reading
South CarolinaMedical University of South Carolina, Charleston
TennesseeTennessee Oncology - Chattanooga, Chattanooga
Tennessee Cancer Specialists, Knoxville
University of Tennessee, Knoxville
SCRI Oncology Partners, Nashville
Tennessee Oncology, Nashville
TexasTexas Oncology South, Austin
Parkland Health and Hospital System, Dallas
Texas Oncology DFW, Dallas
UT Southwestern Medical Center, Dallas
MD Anderson Cancer Center, Houston
Oncology Consultants Texas, Houston
Texas Oncology San Antonio Northeast, San Antonio
Community Clinical Trials, Spring
Texas Oncology - Northeast, Tyler
The University of Texas Health Science Center at Tyler, Tyler
Texas Oncology-Gulf Coast, Webster
UtahHuntsman Cancer Institute, Salt Lake City
VirginiaVirginia Cancer Specialists, Fairfax
WashingtonVista Oncology, Olympia
Summit Cancer Centers, Spokane

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.