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)
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
- Carcinoma, Non-Small-Cell Lung
At a glance
- Phase
- Phase 2
- Study type
- Interventional
- Sponsor
- Janssen Research & Development, LLC
- Enrolment target
- 480
- Started
- 16 December 2024
- Main results due
- 23 May 2029
- Study sites
- 204
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the 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)
What this study is about
In the sponsor’s own words, from the registry.
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).
Study sites(204)
Southern Cancer Center, PC
Daphne, Alabama, United States
Recruiting
Clearview Cancer Institute
Huntsville, Alabama, United States
Completed
City of Hope Phoenix
Goodyear, Arizona, United States
Recruiting
The Oncology Institute of Hope and Innovation
Cerritos, California, United States
Recruiting
City of Hope Corona
Corona, California, United States
Recruiting
City of Hope
Duarte, California, United States
Recruiting
Providence Medical Foundation
Fullerton, California, United States
Recruiting
Oncology Physicians Network Healthcare
Glendale, California, United States
Completed
Los Angeles Cancer Network
Glendale, California, United States
Recruiting
Glendale Adventist Medical Center
Glendale, California, United States
Recruiting
Marin Cancer Center
Greenbrae, California, United States
Recruiting
City of Hope Seacliff
Huntington Beach, California, United States
Recruiting
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, United States
Recruiting
University of California San Diego Health
La Jolla, California, United States
Recruiting
City of Hope Antelope Valley
Lancaster, California, United States
Recruiting
City of Hope Long Beach Elm
Long Beach, California, United States
Recruiting
Cancer and Blood Specialty Clinic
Los Alamitos, California, United States
Recruiting
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Recruiting
Cedars Sinai Medical Center
Los Angeles, California, United States
Recruiting
Valkyrie Clinical Trials
Los Angeles, California, United States
Recruiting
Valkyrie Clinical Trials Murrieta
Murrieta, California, United States
Recruiting
Kaiser Permanente Oakland Medical Center
Oakland, California, United States
Completed
St. Joseph Hospital Center for Cancer Prevention and Treatment
Orange, California, United States
Recruiting
University of California Irvine
Orange, California, United States
Recruiting
Sutter Health Palo Alto Medical Foundation
Palo Alto, California, United States
Completed
Kaiser Permanente Roseville Medical Center
Roseville, California, United States
Completed
UC Davis Comprehensive Cancer Center
Sacramento, California, United States
Recruiting
Sutter Institute for Medical Research
Sacramento, California, United States
Completed
California Pacific Medical Center
San Francisco, California, United States
Completed
Kaiser Permanente San Francisco Medical Center
San Francisco, California, United States
Completed
UCSF Zuckerberg San Francisco General Hospital
San Francisco, California, United States
Recruiting
Sansum Clinic
Santa Barbara, California, United States
Recruiting
Kaiser Permanente Santa Clara Medical Center
Santa Clara, California, United States
Recruiting
Providence Medical Foundation 1
Santa Rosa, California, United States
Recruiting
City of Hope South Pasadena
South Pasadena, California, United States
Recruiting
City of Hope Upland
Upland, California, United States
Recruiting
Kaiser Permanente Northern California
Vallejo, California, United States
Recruiting
Kaiser Permanente Walnut Creek Medical Center
Walnut Creek, California, United States
Recruiting
John Muir Health Clinical Research Center
Walnut Creek, California, United States
Recruiting
National Jewish Health
Denver, Colorado, United States
Completed
Saint Josephs Hospital Cancer Centers of Colorado
Denver, Colorado, United States
Completed
Lutheran Hospital Cancer Centers of Colorado
Golden, Colorado, United States
Completed
Rocky Mountain Cancer Centers
Lone Tree, Colorado, United States
Recruiting
Yale New Haven Hospital Yale Cancer Center
New Haven, Connecticut, United States
Recruiting
ChristianaCare Helen F Graham Cancer Center and Research Institute
Newark, Delaware, United States
Recruiting
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Recruiting
Washington DC VA Medical Center
Washington D.C., District of Columbia, United States
Recruiting
Baptist Lynn Cancer Institute
Boca Raton, Florida, United States
Recruiting
The Oncology Institute of Hope and Innovation 1
Fort Lauderdale, Florida, United States
Recruiting
Florida Cancer Specialists
Fort Myers, Florida, United States
Recruiting
Univ of Florida
Gainesville, Florida, United States
Recruiting
Memorial Regional Hospital
Hollywood, Florida, United States
Recruiting
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States
Recruiting
Mayo Clinic
Jacksonville, Florida, United States
Recruiting
Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Recruiting
Baptist Health Miami Cancer Institute
Miami, Florida, United States
Recruiting
AdventHealth Orlando
Orlando, Florida, United States
Recruiting
Orlando Health Cancer Institute
Orlando, Florida, United States
Recruiting
Memorial Cancer Institute
Pembroke Pines, Florida, United States
Recruiting
Florida Cancer Specialists & Research Institute 1
St. Petersburg, Florida, United States
Recruiting
Showing 60 of 204 sites — filter to narrow it down. 173 of the 204 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06667076. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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