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).

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)

Carcinoma, Non-Small-Cell Lung

Carcinoma, Non-small-Cell Lung

Carcinoma, Non-Small Cell Lung

Non-Small Cell Lung Cancer

Non-Small-Cell Lung Carcinoma

Lung Cancer

Lung; Node

Cancer of the Lung

Cancer of Lung

Neoplasms, Lung

Lung Neoplasms

Advanced Solid Tumors

Cancer

Advanced Solid Malignancies

Advanced Solid Tumor

Solid Tumor, Adult

Neoplasms

Adenocarcinoma

Advanced Stage Solid Tumors

Amivantamab

Lazertinib

Chemotherapy: Pemetrexed

Chemotherapy: Carboplatin

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

PFS is defined as the time from the date of first dose of any study treatment until the
date of objective disease progression or death, whichever occurs first according to
response evaluation criteria in solid tumors (RECIST) version (v) 1.1 as assessed by the
investigator.

Participants with dose reductions, interruptions, and discontinuations will be reported.

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.

Participants with dermatologic AEs will be reported.

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.

OS is defined as the time from the date of first dose of any study treatment until the
date of death due to any cause.

ORR is defined as the percentage of participants who achieve either a partial response
(PR) or complete response (CR) as their best response both confirmed and unconfirmed, as
defined using RECIST v1.1.

CBR is defined as the percentage of participants achieving CR or PR, both confirmed and
unconfirmed, or durable stable disease (SD) of a duration of at least 11 weeks as defined
using RECIST v1.1.

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 occurs first, for participants who
have PR or CR.

TTTD is defined as the date from the date of first dose of any study treatment until
discontinuation of study treatment for any reason, including disease progression,
treatment toxicity or death, based on RECIST v 1.1.

TTST is defined as the time from the date of first dose of any study treatment until the
start date of the subsequent anticancer therapy following study treatment discontinuation
or death, whichever occurs first.

TTSP is defined as the time from date of first dose of any study treatment 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 systemic
anticancer treatment and/or clinical intervention to manage symptoms or death.

Participants will receive Amivantamab in combination with Lazertinib orally in 28-day
cycles until disease progression, withdrawal of consent, death, or the investigator
decides to discontinue treatment, whichever comes first.

Participants will receive Amivantamab in combination with chemotherapy (carboplatin and
pemetrexed) intravenous (IV) infusion in 21-day cycles until disease progression,
withdrawal of consent, death, or the investigator decides to discontinue treatment,
whichever comes first.

Southern Cancer Center, PC

Clearview Cancer Institute

Cancer Treatment Center of America Phoenix

City of Hope Corona

City of Hope

Providence Medical Foundation

The Oncology Institute of Hope and Innovation

Oncology Physicians Network Healthcare

Los Angeles Cancer Network

Glendale Adventist Medical Center

Marin Cancer Center

City of Hope Seacliff

City of Hope Orange County Lennar Foundation Cancer Center

University of California San Diego Health

City of Hope Antelope Valley

City of Hope Long Beach Elm

Cancer and Blood Specialty Clinic

USC Norris Comprehensive Cancer Center

Cedars Sinai Medical Center

Valkyrie Clinical Trials

Kaiser Permanente Oakland Medical Center

St. Joseph Hospital Center for Cancer Prevention and Treatment

University of California Irvine

Kaiser Permanente Roseville Medical Center

UC Davis Comprehensive Cancer Center

Sutter Institute for Medical Research

Kaiser Permanente San Francisco Medical Center

UCSF Zuckerberg San Francisco General Hospital

Sansum Clinic

Kaiser Permanente Santa Clara Medical Center

City of Hope South Pasadena

City of Hope Upland

Kaiser Permanente Northern California

Kaiser Permanente Walnut Creek Medical Center

John Muir Health Clinical Research Center

Saint Josephs Hospital Cancer Centers of Colorado

Lutheran Hospital Cancer Centers of Colorado

Rocky Mountain Cancer Centers

Yale New Haven Hospital Yale Cancer Center

ChristianaCare Helen F Graham Cancer Center and Research Institute

MedStar Georgetown University Hospital

Washington DC VA Medical Center

Baptist Lynn Cancer Institute

Florida Cancer Specialists

Univ of Florida

Baptist MD Anderson Cancer Center

AdventHealth Orlando

Orlando Health Cancer Institute

Florida Cancer Specialists & Research Institute

Moffitt Cancer Center

University Cancer And Blood Center LLC

Grady Health System Correll Pavilion

Piedmont Healthcare

Piedmont Cancer Institute

Winship Cancer Institute Emory University

City of Hope Cancer Center

University of Illinois at Chicago

Cancer Care Specialists of Central Illinois

Hope and Healing Cancer Services

Illinois Cancer Specialists

City of Hope Chicago

Fort Wayne Medical Oncology and Hematology

Investigative Clinical Research of Indiana, LLC

Accellacare of McFarland

University of Kansas Cancer Center

University of Maryland

Maryland Oncology Hematology P A

Boston University Medical Center

Beth Israel Deaconess Medical Center

Dana Farber Cancer Institute

Trinity Health St Joseph Mercy Ann Arbor

University Of Minnesota

Jackson Oncology Associates

Truman Medical Ctr West

Oncology Hematology Associates

Washington University School Of Medicine

Dartmouth Hitchcock Medical Center

Hunterdon Hematology Oncology

Morristown Medical Center

Rutgers Cancer Institute of New Jersey

Overlook Medical Center

Holy Name Medical Center

University of New Mexico

Hematology-Oncology Associates of CNY

Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island

NYU Langone Health Laura and Isaac Perlmutter Cancer Center

Herbert Irving Comprehensive Cancer Center Columbia University Medical Center

Ellis Hospital

New York Cancer and Blood Specialists

Montefiore Medical Center

Clinical Research Alliance Inc

Regional Medical Oncology Center

University of Cincinnati

Oncology Associates of Oregon PC Willamette Valley Cancer Institute

Oregon Health And Science University

Lankenau Institute for Medical Research Main Line Health Bryn Mawr Hospital

Community Clinical Trials

Summit Cancer Centers

City of Hope Phoenix

National Jewish Health

California Pacific Medical Center

Sutter Health Palo Alto Medical Foundation

Baptist Health Miami Cancer Institute

Lankenau Institute for Medical Research Main Line Health Paoli Hospital

Philadelphia VA Medical Center

Lankenau Institute for Medical Research

Avera Medical Group

Tennessee Oncology

Tennessee Cancer Specialists

University of Tennessee

SCRI Oncology Partners

Texas Oncology DFW

UT Southwestern Medical Center

Renovatio Clinical

MD Anderson Cancer Center

Oncology Consultants Texas

The University of Texas Health Science Center at Tyler

Texas Oncology-Gulf Coast

Huntsman Cancer Institute

JPS Health Network

Virginia Cancer Specialists

Vista Oncology

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)

Trials at a glance

Trials at a glance

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)

Outcome measures

Primary outcome measures

Secondary outcome measures