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)
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- Registration Number
- NCT06667076
- Lead Sponsor
- Janssen Research & Development, LLC
- Brief Summary
The primary purpose of the study is to assess how well amivantamab subcutaneous (SC) administration 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 365
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1: Amivantamab and Lazertinib Amivantamab Participants will receive Amivantamab subcutaneous (SC) injection in combination with Lazertinib orally in 28-day cycles until disease progression, withdrawal of consent, or the investigator decides to discontinue treatment, whichever comes first. Cohort 1: Amivantamab and Lazertinib Lazertinib Participants will receive Amivantamab subcutaneous (SC) injection in combination with Lazertinib orally in 28-day cycles until disease progression, withdrawal of consent, or the investigator decides to discontinue treatment, whichever comes first. Cohort 2: Amivantamab and Chemotherapy Amivantamab Participants will receive Amivantamab SC injection in combination with chemotherapy (carboplatin and pemetrexed) intravenous (IV) infusion in 21-day cycles until disease progression, withdrawal of consent, or the investigator decides to discontinue treatment, whichever comes first.
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) Up to 4 Years and 6 months PFS is defined as the time from the first study treatment until the date of objective disease progression or death, whichever comes first according to response evaluation criteria in solid tumors (RECIST) version (v) 1.1 by investigator assessment.
- Secondary Outcome Measures
Name Time Method Number of Participants with AEs by Severity Up to 4 Years and 6 months Severity of AEs will be graded according to the national cancer institute common terminology criteria for adverse event (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening and Grade 5: death related to adverse event.
Number of Participants Reporting Dose Reductions, Interruptions, and Discontinuations Up to 4 Years and 6 months Participants with dose reductions, interruptions, and discontinuations will be reported.
Number of Participants With Venous Thromboembolic Events (VTEs) Up to 4 Years and 6 months Participants with signs and symptoms (dyspnea, tachypnea, upper- or lower-extremity swelling and discoloration) of VTE events, specifically pulmonary embolism, and deep vein thrombosis will be reported as monitored by the investigators.
Number of Participants With Dermatologic Adverse Events (AEs) Up to 4 Years and 6 months Participants with dermatologic AEs will be reported.
Overall Survival (OS) Up to 4 Years and 6 months OS is defined as the time from the date of the first study treatment until the date of death due to any cause.
Overall Response Rate (ORR) Up to 4 Years and 6 months ORR is defined as the percentage of participants who achieve either a partial response (PR) or complete response (CR) as their best response per clinical assessment using RECIST v1.1.
Clinical Benefit Rate (CBR) Up to 4 Years and 6 months CBR is defined as the percentage of participants achieving CR or PR, or durable standard deviation (SD) of a duration of at least 11 weeks as defined by RECIST v1.1.
Duration of Response (DOR) Up to 4 Years and 6 months DOR is defined as the time from the date of first documented response (PR or CR) until the date of documented progression or death, whichever comes first, for participants who have PR or CR.
Intracranial Progression-Free Survival (PFS) Up to 4 Years and 6 months Intracranial PFS is defined as the time from treatment initiation until the date of objective intracranial disease progression or death, whichever comes first, based on investigator-assessed RECIST v1.1.
Time to Treatment Discontinuation (TTD) Up to 4 Years and 6 months TTD is defined as the date from the first study treatment to discontinuation of treatment for any reason, including disease progression, treatment toxicity or death, based on RECIST v 1.1.
Time to Next Therapy (TTNT) Up to 4 Years and 6 months TTNT is defined as the time from the date of the first study treatment to the start date of the subsequent anticancer therapy following study treatment discontinuation or death, whichever comes first.
Time to Symptomatic Progression (TTSP) Up to 4 Years and 6 months TTSP is defined as the time from treatment initiation to documentation in the electronic case report form (eCRF) of any of the following (whichever occurs earlier): onset of new symptoms or symptom worsening that is considered by the investigator to be related to lung cancer and requires either a change in anticancer treatment and/or clinical intervention to manage symptoms or death.
Cohort 1: Number of Participants Reporting Compliance with Anticoagulation Medications Up to 4 Years and 6 months Participants reporting compliance with anticoagulation medications will be reported.
Number of Participants Reporting Compliance with Enhanced Dermatologic AE Management Concomitant Medications Up to 4 Years and 6 months Participants reporting compliance with enhanced dermatologic AE management concomitant medications will be reported.
Trial Locations
- Locations (111)
Southern Cancer Center, PC
🇺🇸Daphne, Alabama, United States
Sutter Institute for Medical Research
🇺🇸Sacramento, California, United States
Sansum Clinic
🇺🇸Santa Barbara, California, United States
Rocky Mountain Cancer Centers
🇺🇸Lone Tree, Colorado, United States
ChristianaCare Helen F Graham Cancer Center and Research Institute
🇺🇸Newark, Delaware, United States
Baptist Lynn Cancer Institute
🇺🇸Boca Raton, Florida, United States
AdventHealth Orlando
🇺🇸Orlando, Florida, United States
University Cancer And Blood Center LLC
🇺🇸Athens, Georgia, United States
Illinois Cancer Specialists
🇺🇸Niles, Illinois, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Truman Medical Ctr West
🇺🇸Kansas City, Missouri, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Lankenau Institute for Medical Research Main Line Health Bryn Mawr Hospital
🇺🇸Bryn Mawr, Pennsylvania, United States
Lankenau Institute for Medical Research Main Line Health Paoli Hospital
🇺🇸Paoli, Pennsylvania, United States
Philadelphia VA Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Lankenau Institute for Medical Research
🇺🇸Wynnewood, Pennsylvania, United States
Texas Oncology Odessa-West Texas Cancer Center
🇺🇸Odessa, Texas, United States
Texas Oncology-Gulf Coast
🇺🇸Webster, Texas, United States
Virginia Cancer Specialists
🇺🇸Fairfax, Virginia, United States
Clearview Cancer Institute
🇺🇸Huntsville, Alabama, United States
Cancer Treatment Center of America Phoenix
🇺🇸Goodyear, Arizona, United States
City of Hope Corona
🇺🇸Corona, California, United States
City of Hope
🇺🇸Duarte, California, United States
Providence Medical Foundation
🇺🇸Santa Rosa, California, United States
The Oncology Institute of Hope and Innovation
🇺🇸Fort Lauderdale, Florida, United States
Oncology Physicians Network Healthcare
🇺🇸Glendale, California, United States
Los Angeles Cancer Network
🇺🇸Glendale, California, United States
Glendale Adventist Medical Center
🇺🇸Glendale, California, United States
Marin Cancer Center
🇺🇸Greenbrae, California, United States
City of Hope Seacliff
🇺🇸Huntington Beach, California, United States
City of Hope Orange County Lennar Foundation Cancer Center
🇺🇸Irvine, California, United States
City of Hope Antelope Valley
🇺🇸Lancaster, California, United States
City of Hope Long Beach Elm
🇺🇸Long Beach, California, United States
Cancer and Blood Specialty Clinic
🇺🇸Los Alamitos, California, United States
USC Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
Valkyrie Clinical Trials
🇺🇸Murrieta, California, United States
Kaiser Permanente Oakland Medical Center
🇺🇸Oakland, California, United States
St. Joseph Hospital Center for Cancer Prevention and Treatment
🇺🇸Orange, California, United States
University of California Irvine
🇺🇸Orange, California, United States
Kaiser Permanente Roseville Medical Center
🇺🇸Roseville, California, United States
Kaiser Permanente San Francisco Medical Center
🇺🇸San Francisco, California, United States
UCSF Zuckerberg San Francisco General Hospital
🇺🇸San Francisco, California, United States
Kaiser Permanente Santa Clara Medical Center
🇺🇸Santa Clara, California, United States
City of Hope South Pasadena
🇺🇸South Pasadena, California, United States
City of Hope Upland
🇺🇸Upland, California, United States
Kaiser Permanente Northern California
🇺🇸Vallejo, California, United States
Kaiser Permanente Walnut Creek Medical Center
🇺🇸Walnut Creek, California, United States
John Muir Health Clinical Research Center
🇺🇸Walnut Creek, California, United States
Yale New Haven Hospital Yale Cancer Center
🇺🇸New Haven, Connecticut, United States
MedStar Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
Washington DC VA Medical Center
🇺🇸Washington, District of Columbia, United States
Piedmont Cancer Institute
🇺🇸Atlanta, Georgia, United States
Cancer Care Specialists of Central Illinois
🇺🇸Decatur, Illinois, United States
Hope and Healing Cancer Services
🇺🇸Hinsdale, Illinois, United States
Orlando Health Cancer Institute
🇺🇸Orlando, Florida, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Grady Health System Correll Pavilion
🇺🇸Atlanta, Georgia, United States
Piedmont Healthcare
🇺🇸Atlanta, Georgia, United States
Winship Cancer Institute Emory University
🇺🇸Atlanta, Georgia, United States
City of Hope Cancer Center
🇺🇸Newnan, Georgia, United States
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
City of Hope Chicago
🇺🇸Zion, Illinois, United States
Fort Wayne Medical Oncology and Hematology
🇺🇸Fort Wayne, Indiana, United States
Investigative Clinical Research of Indiana, LLC
🇺🇸Noblesville, Indiana, United States
Accellacare of McFarland
🇺🇸Ames, Iowa, United States
Maryland Oncology Hematology P A
🇺🇸Silver Spring, Maryland, United States
Boston University Medical Center
🇺🇸Boston, Massachusetts, United States
Trinity Health St Joseph Mercy Ann Arbor
🇺🇸Ypsilanti, Michigan, United States
University Of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Jackson Oncology Associates
🇺🇸Jackson, Mississippi, United States
Washington University School Of Medicine
🇺🇸Saint Louis, Missouri, United States
Oncology Hematology Associates
🇺🇸Springfield, Missouri, United States
Hunterdon Hematology Oncology
🇺🇸Flemington, New Jersey, United States
Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Overlook Medical Center
🇺🇸Summit, New Jersey, United States
Holy Name Medical Center
🇺🇸Teaneck, New Jersey, United States
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Hematology-Oncology Associates of CNY
🇺🇸East Syracuse, New York, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island
🇺🇸Mineola, New York, United States
NYU Langone Health Laura and Isaac Perlmutter Cancer Center
🇺🇸New York, New York, United States
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
🇺🇸New York, New York, United States
Ellis Hospital
🇺🇸Schenectady, New York, United States
New York Cancer and Blood Specialists
🇺🇸Shirley, New York, United States
Clinical Research Alliance Inc
🇺🇸Westbury, New York, United States
Regional Medical Oncology Center
🇺🇸Wilson, North Carolina, United States
Oncology Associates of Oregon PC Willamette Valley Cancer Institute
🇺🇸Eugene, Oregon, United States
Oregon Health And Science University
🇺🇸Portland, Oregon, United States
McGlinn Cancer Institute Reading Hospital
🇺🇸West Reading, Pennsylvania, United States
Avera Medical Group
🇺🇸Sioux Falls, South Dakota, United States
Tennessee Oncology
🇺🇸Nashville, Tennessee, United States
University of Tennessee
🇺🇸Knoxville, Tennessee, United States
Baptist Cancer Center
🇺🇸Memphis, Tennessee, United States
SCRI Oncology Partners
🇺🇸Nashville, Tennessee, United States
Texas Oncology P A
🇺🇸Dallas, Texas, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Renovatio Clinical
🇺🇸The Woodlands, Texas, United States
JPS Health Network
🇺🇸Fort Worth, Texas, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Oncology Consultants Texas
🇺🇸Houston, Texas, United States
Community Clinical Trials
🇺🇸Kingwood, Texas, United States
The University of Texas Health Science Center at Tyler
🇺🇸Tyler, Texas, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Vista Oncology
🇺🇸Olympia, Washington, United States
Summit Cancer Centers
🇺🇸Spokane, Washington, United States
Northwest Cancer Specialists - Vancouver
🇺🇸Vancouver, Washington, United States
Auxilio Mutuo Cancer Center
🇵🇷San Juan, Puerto Rico