Clinical trial NCT06667076: 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)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2024-10-31
Enrollment: 365
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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)

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Up to 4 Years and 6 months
Secondary outcomes:
measure: Number of Participants Reporting Dose Reductions, Interruptions, and Discontinuations
timeFrame: Up to 4 Years and 6 months
measure: Number of Participants With Venous Thromboembolic Events (VTEs)
timeFrame: Up to 4 Years and 6 months
measure: Number of Participants With Dermatologic Adverse Events (AEs)
timeFrame: Up to 4 Years and 6 months
measure: Number of Participants with AEs by Severity
timeFrame: Up to 4 Years and 6 months
measure: Overall Survival (OS)
timeFrame: Up to 4 Years and 6 months
measure: Overall Response Rate (ORR)
timeFrame: Up to 4 Years and 6 months
measure: Clinical Benefit Rate (CBR)
timeFrame: Up to 4 Years and 6 months
measure: Duration of Response (DOR)
timeFrame: Up to 4 Years and 6 months
measure: Intracranial Progression-Free Survival (PFS)
timeFrame: Up to 4 Years and 6 months
measure: Time to Treatment Discontinuation (TTD)
timeFrame: Up to 4 Years and 6 months
measure: Time to Next Therapy (TTNT)
timeFrame: Up to 4 Years and 6 months
measure: Time to Symptomatic Progression (TTSP)
timeFrame: Up to 4 Years and 6 months
measure: Cohort 1: Number of Participants Reporting Compliance with Anticoagulation Medications
timeFrame: Up to 4 Years and 6 months
measure: Number of Participants Reporting Compliance with Enhanced Dermatologic AE Management Concomitant Medications
timeFrame: Up to 4 Years and 6 months
Other outcomes:
Locations:
city: Daphne
country: United States
facility: Southern Cancer Center, PC
state: Alabama
city: Huntsville
country: United States
facility: Clearview Cancer Institute
state: Alabama
city: Goodyear
country: United States
facility: Cancer Treatment Center of America Phoenix
state: Arizona
city: Corona
country: United States
facility: City of Hope Corona
state: California
city: Duarte
country: United States
facility: City of Hope
state: California
city: Fullerton
country: United States
facility: Providence Medical Foundation
state: California
city: Glendale
country: United States
facility: The Oncology Institute of Hope and Innovation
state: California
city: Glendale
country: United States
facility: Oncology Physicians Network Healthcare
state: California
city: Glendale
country: United States
facility: Los Angeles Cancer Network
state: California
city: Glendale
country: United States
facility: Glendale Adventist Medical Center
state: California
city: Greenbrae
country: United States
facility: Marin Cancer Center
state: California
city: Huntington Beach
country: United States
facility: City of Hope Seacliff
state: California
city: Irvine
country: United States
facility: City of Hope Orange County Lennar Foundation Cancer Center
state: California
city: Lancaster
country: United States
facility: City of Hope Antelope Valley
state: California
city: Long Beach
country: United States
facility: City of Hope Long Beach Elm
state: California
city: Los Alamitos
country: United States
facility: Cancer and Blood Specialty Clinic
state: California
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: Valkyrie Clinical Trials
state: California
city: Murrieta
country: United States
facility: Valkyrie Clinical Trials
state: California
city: Oakland
country: United States
facility: Kaiser Permanente Oakland Medical Center
state: California
city: Orange
country: United States
facility: St. Joseph Hospital Center for Cancer Prevention and Treatment
state: California
city: Orange
country: United States
facility: University of California Irvine
state: California
city: Roseville
country: United States
facility: Kaiser Permanente Roseville Medical Center
state: California
city: Sacramento
country: United States
facility: Sutter Institute for Medical Research
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente San Francisco Medical Center
state: California
city: San Francisco
country: United States
facility: UCSF Zuckerberg San Francisco General Hospital
state: California
city: Santa Barbara
country: United States
facility: Sansum Clinic
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente Santa Clara Medical Center
state: California
city: Santa Rosa
country: United States
facility: Providence Medical Foundation
state: California
city: South Pasadena
country: United States
facility: City of Hope South Pasadena
state: California
city: Upland
country: United States
facility: City of Hope Upland
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente Northern California
state: California
city: Walnut Creek
country: United States
facility: Kaiser Permanente Walnut Creek Medical Center
state: California
city: Walnut Creek
country: United States
facility: John Muir Health Clinical Research Center
state: California
city: Lone Tree
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: New Haven
country: United States
facility: Yale New Haven Hospital Yale Cancer Center
state: Connecticut
city: Newark
country: United States
facility: ChristianaCare Helen F Graham Cancer Center and Research Institute
state: Delaware
city: Washington
country: United States
facility: MedStar Georgetown University Hospital
state: District of Columbia
city: Washington
country: United States
facility: Washington DC VA Medical Center
state: District of Columbia
city: Boca Raton
country: United States
facility: Baptist Lynn Cancer Institute
state: Florida
city: Fort Lauderdale
country: United States
facility: The Oncology Institute of Hope and Innovation
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Orlando
country: United States
facility: Orlando Health Cancer Institute
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Athens
country: United States
facility: University Cancer And Blood Center LLC
state: Georgia
city: Atlanta
country: United States
facility: Grady Health System Correll Pavilion
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Healthcare
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Cancer Institute
state: Georgia
city: Atlanta
country: United States
facility: Winship Cancer Institute Emory University
state: Georgia
city: Newnan
country: United States
facility: City of Hope Cancer Center
state: Georgia
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Decatur
country: United States
facility: Cancer Care Specialists of Central Illinois
state: Illinois
city: Hinsdale
country: United States
facility: Hope and Healing Cancer Services
state: Illinois
city: Niles
country: United States
facility: Illinois Cancer Specialists
state: Illinois
city: Zion
country: United States
facility: City of Hope Chicago
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology and Hematology
state: Indiana
city: Noblesville
country: United States
facility: Investigative Clinical Research of Indiana, LLC
state: Indiana
city: Ames
country: United States
facility: Accellacare of McFarland
state: Iowa
city: Silver Spring
country: United States
facility: Maryland Oncology Hematology P A
state: Maryland
city: Boston
country: United States
facility: Boston University Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Ypsilanti
country: United States
facility: Trinity Health St Joseph Mercy Ann Arbor
state: Michigan
city: Minneapolis
country: United States
facility: University Of Minnesota
state: Minnesota
city: Jackson
country: United States
facility: Jackson Oncology Associates
state: Mississippi
city: Kansas City
country: United States
facility: Truman Medical Ctr West
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School Of Medicine
state: Missouri
city: Springfield
country: United States
facility: Oncology Hematology Associates
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Flemington
country: United States
facility: Hunterdon Hematology Oncology
state: New Jersey
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Summit
country: United States
facility: Overlook Medical Center
state: New Jersey
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: East Syracuse
country: United States
facility: Hematology-Oncology Associates of CNY
state: New York
city: Mineola
country: United States
facility: Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island
state: New York
city: New York
country: United States
facility: NYU Langone Health Laura and Isaac Perlmutter Cancer Center
state: New York
city: New York
country: United States
facility: Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
state: New York
city: Schenectady
country: United States
facility: Ellis Hospital
state: New York
city: Shirley
country: United States
facility: New York Cancer and Blood Specialists
state: New York
city: Westbury
country: United States
facility: Clinical Research Alliance Inc
state: New York
city: Wilson
country: United States
facility: Regional Medical Oncology Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Eugene
country: United States
facility: Oncology Associates of Oregon PC Willamette Valley Cancer Institute
state: Oregon
city: Portland
country: United States
facility: Oregon Health And Science University
state: Oregon
city: Bryn Mawr
country: United States
facility: Lankenau Institute for Medical Research Main Line Health Bryn Mawr Hospital
state: Pennsylvania
city: Paoli
country: United States
facility: Lankenau Institute for Medical Research Main Line Health Paoli Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Philadelphia VA Medical Center
state: Pennsylvania
city: West Reading
country: United States
facility: McGlinn Cancer Institute Reading Hospital
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Institute for Medical Research
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Avera Medical Group
state: South Dakota
city: Chattanooga
country: United States
facility: Tennessee Oncology
state: Tennessee
city: Knoxville
country: United States
facility: University of Tennessee
state: Tennessee
city: Memphis
country: United States
facility: Baptist Cancer Center
state: Tennessee
city: Nashville
country: United States
facility: SCRI Oncology Partners
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology P A
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: El Paso
country: United States
facility: Renovatio Clinical
state: Texas
city: Fort Worth
country: United States
facility: JPS Health Network
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: Oncology Consultants Texas
state: Texas
city: Kingwood
country: United States
facility: Community Clinical Trials
state: Texas
city: Odessa
country: United States
facility: Texas Oncology Odessa-West Texas Cancer Center
state: Texas
city: The Woodlands
country: United States
facility: Renovatio Clinical
state: Texas
city: Tyler
country: United States
facility: The University of Texas Health Science Center at Tyler
state: Texas
city: Webster
country: United States
facility: Texas Oncology-Gulf Coast
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Fairfax
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: Olympia
country: United States
facility: Vista Oncology
state: Washington
city: Spokane
country: United States
facility: Summit Cancer Centers
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer Specialists - Vancouver
state: Washington
city: San Juan
country: Puerto Rico
facility: Auxilio Mutuo Cancer Center
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: