RECRUITING

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)

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Conditions

Carcinoma, Non-Small-Cell Lung

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2024-12-16
Study Completion:2029-06-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06667076

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC) that is not amenable to curative intent therapy
  2. * 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
  3. * Have at least 1 measurable lesion, according to RECIST version (v)1.1, that has not been previously irradiated
  4. * 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)
  5. * Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1
  1. * 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
  2. * 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
  3. * Participant has uncontrolled tumor-related pain (symptomatic lesions amenable to palliative radiotherapy should be treated prior to first dosing)
  4. * 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
  5. * 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)

Contacts and Locations

Study Contact

Study Contact
CONTACT
844-434-4210
Participate-In-This-Study1@its.jnj.com

Principal Investigator

Janssen Research & Development, LLC Clinical Trial
STUDY_DIRECTOR
Janssen Research & Development, LLC

Study Locations (Sites)

Southern Cancer Center, PC
Daphne, Alabama, 36526
United States
Clearview Cancer Institute
Huntsville, Alabama, 35805
United States
Cancer Treatment Center of America Phoenix
Goodyear, Arizona, 85338
United States
City of Hope Corona
Corona, California, 92882
United States
City of Hope
Duarte, California, 91010
United States
Providence Medical Foundation
Fullerton, California, 92835
United States
The Oncology Institute of Hope and Innovation
Glendale, California, 90015
United States
Oncology Physicians Network Healthcare
Glendale, California, 91203
United States
Los Angeles Cancer Network
Glendale, California, 91204
United States
Glendale Adventist Medical Center
Glendale, California, 91206
United States
Marin Cancer Center
Greenbrae, California, 94904
United States
City of Hope Seacliff
Huntington Beach, California, 92648
United States
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, 92618
United States
City of Hope Antelope Valley
Lancaster, California, 93534
United States
City of Hope Long Beach Elm
Long Beach, California, 90813
United States
Cancer and Blood Specialty Clinic
Los Alamitos, California, 90720
United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
Cedars Sinai Medical Center
Los Angeles, California, 90048
United States
Valkyrie Clinical Trials
Los Angeles, California, 90067
United States
Valkyrie Clinical Trials
Murrieta, California, 92562
United States
Kaiser Permanente Oakland Medical Center
Oakland, California, 94611
United States
St. Joseph Hospital Center for Cancer Prevention and Treatment
Orange, California, 92868
United States
University of California Irvine
Orange, California, 92868
United States
Kaiser Permanente Roseville Medical Center
Roseville, California, 95661
United States
Sutter Institute for Medical Research
Sacramento, California, 95816
United States
Kaiser Permanente San Francisco Medical Center
San Francisco, California, 94115
United States
UCSF Zuckerberg San Francisco General Hospital
San Francisco, California, 94143
United States
Sansum Clinic
Santa Barbara, California, 93105
United States
Kaiser Permanente Santa Clara Medical Center
Santa Clara, California, 95051
United States
Providence Medical Foundation
Santa Rosa, California, 95403
United States
City of Hope South Pasadena
South Pasadena, California, 91030
United States
City of Hope Upland
Upland, California, 91786
United States
Kaiser Permanente Northern California
Vallejo, California, 94589
United States
Kaiser Permanente Walnut Creek Medical Center
Walnut Creek, California, 94596
United States
John Muir Health Clinical Research Center
Walnut Creek, California, 94598
United States
Saint Josephs Hospital Cancer Centers of Colorado
Denver, Colorado, 80218
United States
Lutheran Hospital Cancer Centers of Colorado
Golden, Colorado, 80401
United States
Rocky Mountain Cancer Centers
Lone Tree, Colorado, 80124
United States
Yale New Haven Hospital Yale Cancer Center
New Haven, Connecticut, 06520
United States
ChristianaCare Helen F Graham Cancer Center and Research Institute
Newark, Delaware, 19713
United States
MedStar Georgetown University Hospital
Washington, District of Columbia, 20007
United States
Washington DC VA Medical Center
Washington, District of Columbia, 20422
United States
Baptist Lynn Cancer Institute
Boca Raton, Florida, 33486
United States
The Oncology Institute of Hope and Innovation
Fort Lauderdale, Florida, 33316
United States
Florida Cancer Specialists
Fort Myers, Florida, 33916
United States
AdventHealth Orlando
Orlando, Florida, 32803
United States
Orlando Health Cancer Institute
Orlando, Florida, 32806
United States
Florida Cancer Specialists & Research Institute
Saint Petersburg, Florida, 33705
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States
Florida Cancer Specialists & Research Institute
West Palm Beach, Florida, 33401
United States
University Cancer And Blood Center LLC
Athens, Georgia, 30607
United States
Grady Health System Correll Pavilion
Atlanta, Georgia, 30303
United States
Piedmont Healthcare
Atlanta, Georgia, 30309
United States
Piedmont Cancer Institute
Atlanta, Georgia, 30318
United States
Winship Cancer Institute Emory University
Atlanta, Georgia, 30322
United States
City of Hope Cancer Center
Newnan, Georgia, 30265
United States
University of Illinois at Chicago
Chicago, Illinois, 60612
United States
Cancer Care Specialists of Central Illinois
Decatur, Illinois, 62526
United States
Hope and Healing Cancer Services
Hinsdale, Illinois, 60521
United States
Illinois Cancer Specialists
Niles, Illinois, 60714
United States
City of Hope Chicago
Zion, Illinois, 60099
United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46804
United States
Investigative Clinical Research of Indiana, LLC
Noblesville, Indiana, 46062
United States
Accellacare of McFarland
Ames, Iowa, 50010
United States
Maryland Oncology Hematology P A
Silver Spring, Maryland, 20904
United States
Boston University Medical Center
Boston, Massachusetts, 02118
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Trinity Health St Joseph Mercy Ann Arbor
Ypsilanti, Michigan, 48197
United States
University Of Minnesota
Minneapolis, Minnesota, 55455
United States
Jackson Oncology Associates
Jackson, Mississippi, 39202
United States
Truman Medical Ctr West
Kansas City, Missouri, 64108
United States
Washington University School Of Medicine
Saint Louis, Missouri, 63110
United States
Oncology Hematology Associates
Springfield, Missouri, 65807
United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
United States
Hunterdon Hematology Oncology
Flemington, New Jersey, 08822
United States
Morristown Medical Center
Morristown, New Jersey, 07960
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
United States
Overlook Medical Center
Summit, New Jersey, 07901
United States
Holy Name Medical Center
Teaneck, New Jersey, 07666
United States
University of New Mexico
Albuquerque, New Mexico, 87102
United States
Montefiore Medical Center
Bronx, New York, 10461
United States
Hematology-Oncology Associates of CNY
East Syracuse, New York, 13057
United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, 11501
United States
NYU Langone Health Laura and Isaac Perlmutter Cancer Center
New York, New York, 10016
United States
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
New York, New York, 10032
United States
Ellis Hospital
Schenectady, New York, 12308
United States
New York Cancer and Blood Specialists
Shirley, New York, 11967
United States
Clinical Research Alliance Inc
Westbury, New York, 11590
United States
Regional Medical Oncology Center
Wilson, North Carolina, 27893
United States
University of Cincinnati
Cincinnati, Ohio, 45219
United States
Oncology Associates of Oregon PC Willamette Valley Cancer Institute
Eugene, Oregon, 97401
United States
Oregon Health And Science University
Portland, Oregon, 97239
United States
Lankenau Institute for Medical Research Main Line Health Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010
United States
Lankenau Institute for Medical Research Main Line Health Paoli Hospital
Paoli, Pennsylvania, 19301
United States
Philadelphia VA Medical Center
Philadelphia, Pennsylvania, 19104
United States
McGlinn Cancer Institute Reading Hospital
West Reading, Pennsylvania, 19611
United States
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, 19096
United States
Avera Medical Group
Sioux Falls, South Dakota, 57105
United States
Tennessee Oncology
Chattanooga, Tennessee, 37404
United States
Tennessee Cancer Specialists
Knoxville, Tennessee, 37909
United States
University of Tennessee
Knoxville, Tennessee, 37920
United States
Baptist Cancer Center
Memphis, Tennessee, 38120
United States
SCRI Oncology Partners
Nashville, Tennessee, 37203
United States
Tennessee Oncology
Nashville, Tennessee, 37203
United States
Texas Oncology DFW
Dallas, Texas, 75246
United States
UT Southwestern Medical Center
Dallas, Texas, 75390
United States
Renovatio Clinical
El Paso, Texas, 79915
United States
JPS Health Network
Fort Worth, Texas, 76104
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States
Oncology Consultants Texas
Houston, Texas, 77030
United States
Community Clinical Trials
Kingwood, Texas, 77339
United States
Texas Oncology Odessa-West Texas Cancer Center
Odessa, Texas, 79761
United States
Renovatio Clinical
The Woodlands, Texas, 77380
United States
The University of Texas Health Science Center at Tyler
Tyler, Texas, 75701
United States
Texas Oncology-Gulf Coast
Webster, Texas, 77598
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031
United States
Vista Oncology
Olympia, Washington, 98506
United States
Summit Cancer Centers
Spokane, Washington, 99208
United States
Northwest Cancer Specialists - Vancouver
Vancouver, Washington, 98684
United States

Collaborators and Investigators

Sponsor: Janssen Research & Development, LLC

  • Janssen Research & Development, LLC Clinical Trial, STUDY_DIRECTOR, Janssen Research & Development, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-16
Study Completion Date2029-06-06

Study Record Updates

Study Start Date2024-12-16
Study Completion Date2029-06-06

Terms related to this study

Additional Relevant MeSH Terms

  • Carcinoma, Non-Small-Cell Lung