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)
Trial Status: active
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).
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)
Additional locations may be listed on ClinicalTrials.gov for NCT06667076.
Locations matching your search criteria
United States
California
Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Name Not AvailableLa Jolla
UC San Diego Moores Cancer Center
Status: Active
Name Not AvailableLos Angeles
USC / Norris Comprehensive Cancer Center
Status: Active
Contact: Xiomara Menendez
Phone: 323-865-0212
Email: menendez_x@med.usc.edu
Los Angeles General Medical Center
Status: Active
Contact: Xiomara Menendez
Phone: 323-865-0212
Email: menendez_x@med.usc.edu
Orange
UC Irvine Health/Chao Family Comprehensive Cancer Center
Status: Active
Contact: Stern Cancer Center
Phone: 877-827-8839
Email: ucstudy@hs.uci.edu
Sacramento
University of California Davis Comprehensive Cancer Center
Status: Active
Name Not AvailableSan Francisco
Zuckerberg San Francisco General Hospital
Status: Active
Contact: UCSF Clinical Trials
Phone: 877-827-3222
Email: cancertrials@ucsf.edu
Connecticut
Derby
Smilow Cancer Hospital-Derby Care Center
Status: Active
Name Not AvailableFairfield
Smilow Cancer Hospital Care Center-Fairfield
Status: Active
Name Not AvailableGreenwich
Smilow Cancer Hospital Care Center at Greenwich
Status: Active
Name Not AvailableGuilford
Smilow Cancer Hospital Care Center - Guilford
Status: Active
Name Not AvailableNew Haven
Yale University
Status: Active
Name Not AvailableStamford
Smilow Cancer Hospital Care Center at Long Ridge
Status: Active
Name Not AvailableTorrington
Smilow Cancer Hospital-Torrington Care Center
Status: Active
Name Not AvailableTrumbull
Smilow Cancer Hospital Care Center-Trumbull
Status: Active
Name Not AvailableWaterbury
Smilow Cancer Hospital-Waterbury Care Center
Status: Active
Name Not AvailableWaterford
Smilow Cancer Hospital Care Center - Waterford
Status: Active
Name Not AvailableDistrict of Columbia
Washington
MedStar Georgetown University Hospital
Status: Active
Name Not AvailableFlorida
Gainesville
University of Florida Health Science Center - Gainesville
Status: Active
Name Not AvailableJacksonville
Mayo Clinic in Florida
Status: Active
Name Not AvailableTampa
Moffitt Cancer Center
Status: Active
Name Not AvailableGeorgia
Atlanta
Emory University Hospital Midtown
Status: Active
Contact: Ticiana A. Leal
Phone: 608-358-8115
Email: ticiana.a.leal@emory.edu
Emory University Hospital/Winship Cancer Institute
Status: Active
Name Not AvailableMaryland
Baltimore
University of Maryland/Greenebaum Cancer Center
Status: Active
Contact: Kaylee Martin
Phone: 410-328-2288
Email: kaylee.martin@umm.edu
Massachusetts
Boston
Beth Israel Deaconess Medical Center
Status: Active
Name Not AvailableDana-Farber Cancer Institute
Status: Active
Name Not AvailableBrigham and Women's Hospital
Status: Active
Name Not AvailableMichigan
Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: Approved
Name Not AvailableMinnesota
Minneapolis
University of Minnesota/Masonic Cancer Center
Status: Active
Name Not AvailableRochester
Mayo Clinic in Rochester
Status: Active
Name Not AvailableMissouri
Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not AvailableNew Hampshire
Lebanon
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Status: Active
Name Not AvailableNew Jersey
New Brunswick
Rutgers Cancer Institute of New Jersey
Status: Active
Name Not AvailableNew Mexico
Albuquerque
University of New Mexico Cancer Center
Status: Active
Name Not AvailableNew York
Bronx
Montefiore Medical Center-Weiler Hospital
Status: Active
Name Not AvailableNew York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Status: Active
Name Not AvailableLaura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Active
Name Not AvailableNorth Carolina
Charlotte
Carolinas Medical Center/Levine Cancer Institute
Status: Active
Name Not AvailableOregon
Portland
OHSU Knight Cancer Institute
Status: Active
Name Not AvailableTexas
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
Status: Active
Name Not AvailableHouston
M D Anderson Cancer Center
Status: Temporarily closed to accrual
Name Not AvailableUtah
Salt Lake City
Huntsman Cancer Institute/University of Utah
Status: Active
Name Not AvailableTrial PhasePhase II
Trial Typetreatment
Lead OrganizationJanssen Pharmaceuticals
- Primary ID61186372NSC2012
- Secondary IDsNCI-2025-00167, 2025-520730-28-00
- ClinicalTrials.gov IDNCT06667076