Home › Non-Small Cell Lung Cancer › NCT06667076
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
- Amivantamab (drug)
- Lazertinib (drug)
- Chemotherapy: Pemetrexed (drug)
- Chemotherapy: Carboplatin (drug)
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.
| Alabama | Southern Cancer Center, PC, Daphne |
| Arizona | City of Hope Phoenix, Goodyear |
| California | The 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 |
| Colorado | Rocky Mountain Cancer Centers, Lone Tree |
| Connecticut | Yale New Haven Hospital Yale Cancer Center, New Haven |
| Delaware | ChristianaCare Helen F Graham Cancer Center and Research Institute, Newark |
| District of Columbia | MedStar Georgetown University Hospital, Washington D.C. Washington DC VA Medical Center, Washington D.C. |
| Florida | Baptist 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 |
| Georgia | Grady Health System Correll Pavilion, Atlanta Piedmont Cancer Institute, Atlanta Piedmont Healthcare, Atlanta Winship Cancer Institute Emory University, Atlanta City of Hope Cancer Center, Newnan |
| Illinois | Rush 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 |
| Indiana | Fort Wayne Medical Oncology and Hematology, Fort Wayne Investigative Clinical Research of Indiana, LLC, Noblesville |
| Iowa | Accellacare of McFarland, Ames |
| Kansas | University of Kansas Cancer Center, Fairway |
| Maryland | University of Maryland, Baltimore Maryland Oncology Hematology P A, Silver Spring |
| Massachusetts | Beth Israel Deaconess Medical Center, Boston Boston University Medical Center, Boston Dana Farber Cancer Institute, Boston |
| Michigan | University of Michigan Health System, Ann Arbor Trinity Health St Joseph Mercy Ann Arbor, Ypsilanti |
| Minnesota | University Of Minnesota, Minneapolis Mayo Clinic Rochester, Rochester |
| Missouri | Truman Medical Ctr West, Kansas City Oncology Hematology Associates, Springfield Washington University School Of Medicine, St Louis |
| New Hampshire | Dartmouth Hitchcock Medical Center, Lebanon |
| New Jersey | Morristown Medical Center, Morristown Rutgers Cancer Institute of New Jersey, New Brunswick Overlook Medical Center, Summit |
| New Mexico | University of New Mexico, Albuquerque |
| New York | Hematology-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 Carolina | Atrium Health, Charlotte Regional Medical Oncology Center, Wilson Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem |
| Ohio | Cincinnati Veterans Affairs Medical Center, Cincinnati |
| Oregon | Oncology Associates of Oregon PC Willamette Valley Cancer Institute, Eugene Oregon Health And Science University, Portland |
| Pennsylvania | Jefferson Health Northeast, Philadelphia Thomas Jefferson University Hospital, Philadelphia McGlinn Cancer Institute Reading Hospital, West Reading |
| South Carolina | Medical University of South Carolina, Charleston |
| Tennessee | Tennessee Oncology - Chattanooga, Chattanooga Tennessee Cancer Specialists, Knoxville University of Tennessee, Knoxville SCRI Oncology Partners, Nashville Tennessee Oncology, Nashville |
| Texas | Texas 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 |
| Utah | Huntsman Cancer Institute, Salt Lake City |
| Virginia | Virginia Cancer Specialists, Fairfax |
| Washington | Vista 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.