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)
Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Oct 30, 2024
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment for patients with a type of lung cancer called non-small cell lung cancer (NSCLC) that has specific genetic mutations known as EGFR mutations. The researchers want to find out how well a drug called amivantamab works when given together with lazertinib or with standard chemotherapy. The goal is to see if this combination can help slow down the cancer or shrink tumors in patients whose cancer has advanced and cannot be cured with surgery.
To participate in this trial, patients need to have a confirmed diagnosis of advanced NSCLC with certain EGFR mutations, and they should have at least one measurable tumor that hasn't been treated with radiation before. Patients must also be generally well with manageable side effects from any previous cancer treatments. During the trial, participants will receive the study drugs and will be monitored for their response to the treatment and any side effects. It’s important to note that those with certain lung diseases or other serious health issues may not be eligible. If you or a loved one think you might qualify, it’s a good idea to discuss it with your healthcare provider for more information.
Gender
ALL
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 in accordance with site standard of care
- • 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
- • 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) or within 12 months 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 Janssen Research & Development, Llc
Janssen Research & Development, LLC, a subsidiary of Johnson & Johnson, is a leading pharmaceutical company dedicated to advancing innovative therapies in multiple therapeutic areas, including oncology, immunology, neuroscience, infectious diseases, and cardiovascular health. With a strong commitment to scientific excellence and patient-centered research, Janssen leverages cutting-edge technology and collaborative partnerships to drive the development of transformative treatments. The company is focused on addressing unmet medical needs through rigorous clinical trials and a robust pipeline, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Minneapolis, Minnesota, United States
Sacramento, California, United States
Lebanon, New Hampshire, United States
Saint Louis, Missouri, United States
Boston, Massachusetts, United States
Salt Lake City, Utah, United States
Chicago, Illinois, United States
Boston, Massachusetts, United States
Duarte, California, United States
Tampa, Florida, United States
Washington, District Of Columbia, United States
Orlando, Florida, United States
Bronx, New York, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Cincinnati, Ohio, United States
Houston, Texas, United States
Orlando, Florida, United States
Morristown, New Jersey, United States
Boston, Massachusetts, United States
Dallas, Texas, United States
Glendale, California, United States
Los Angeles, California, United States
Huntsville, Alabama, United States
Fort Myers, Florida, United States
Los Angeles, California, United States
Athens, Georgia, United States
Lone Tree, Colorado, United States
East Syracuse, New York, United States
Jackson, Mississippi, United States
Nashville, Tennessee, United States
South Pasadena, California, United States
Decatur, Illinois, United States
Knoxville, Tennessee, United States
Orange, California, United States
Lancaster, California, United States
Knoxville, Tennessee, United States
Santa Barbara, California, United States
New Brunswick, New Jersey, United States
Wynnewood, Pennsylvania, United States
Atlanta, Georgia, United States
Washington, District Of Columbia, United States
Atlanta, Georgia, United States
Niles, Illinois, United States
Albuquerque, New Mexico, United States
Summit, New Jersey, United States
Teaneck, New Jersey, United States
Fairfax, Virginia, United States
Vancouver, Washington, United States
Memphis, Tennessee, United States
San Juan, , Puerto Rico
Greenbrae, California, United States
Santa Clara, California, United States
Fort Wayne, Indiana, United States
Fort Worth, Texas, United States
Upland, California, United States
The Woodlands, Texas, United States
Daphne, Alabama, United States
Chattanooga, Tennessee, United States
Oakland, California, United States
Roseville, California, United States
San Francisco, California, United States
Walnut Creek, California, United States
Wilson, North Carolina, United States
Spokane, Washington, United States
Flemington, New Jersey, United States
Saint Petersburg, Florida, United States
Sioux Falls, South Dakota, United States
Silver Spring, Maryland, United States
Atlanta, Georgia, United States
Los Alamitos, California, United States
Springfield, Missouri, United States
West Palm Beach, Florida, United States
Los Angeles, California, United States
Fullerton, California, United States
Odessa, Texas, United States
Schenectady, New York, United States
Long Beach, California, United States
New York, New York, United States
Santa Rosa, California, United States
Olympia, Washington, United States
Tyler, Texas, United States
Irvine, California, United States
El Paso, Texas, United States
Noblesville, Indiana, United States
Boca Raton, Florida, United States
Orange, California, United States
Hinsdale, Illinois, United States
Glendale, California, United States
Westbury, New York, United States
New Haven, Connecticut, United States
Shirley, New York, United States
Nashville, Tennessee, United States
Glendale, California, United States
Huntington Beach, California, United States
Goodyear, Arizona, United States
Dallas, Texas, United States
New York, New York, United States
Zion, Illinois, United States
Fort Lauderdale, Florida, United States
Dallas, Texas, United States
Vallejo, California, United States
Los Angeles, California, United States
Kingwood, Texas, United States
Houston, Texas, United States
Corona, California, United States
Glendale, California, United States
Walnut Creek, California, United States
Ames, Iowa, United States
Ypsilanti, Michigan, United States
Mineola, New York, United States
West Reading, Pennsylvania, United States
Murrieta, California, United States
San Francisco, California, United States
Atlanta, Georgia, United States
Newnan, Georgia, United States
Eugene, Oregon, United States
Newark, Delaware, United States
Kansas City, Missouri, United States
Bryn Mawr, Pennsylvania, United States
Paoli, Pennsylvania, United States
Webster, Texas, United States
Patients applied
Trial Officials
Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported