Study of Amivantamab, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

751

Participants

Timeline

Start Date

May 24, 2016

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Non-Small-Cell Lung Cancer
Interventions
DRUG

Amivantamab

The first cohort of participants will receive IV infusions of Amivantamab 140 mg as monotherapy. Each subsequent cohort will receive IV infusions of Amivantamab at increased dose level until maximum tolerated dose is reached or all planned doses are administered. Participants will receive lazertinib and Amivantamab at predefined dose levels, based upon observed safety and protocol defined criteria. The duration of each treatment cycle is 28 days. In Chemotherapy Combination Cohort, participants will receive Amivantamab, administered on a 21-day cycle, in combination with the administration of standard of care carboplatin and pemetrexed.

DRUG

Amivantamab

Participants will receive IV infusion of Amivantamab as monotherapy at RP2D regimen or in combination lazertinib at RP2CD regimen as determined in Part 1.

DRUG

Lazertinib

Lazertinib will be administered in combination with Amivantamab at predefined dose levels, based upon observed safety and protocol defined criteria. Lazertinib will be administered daily on the 28-day Amivantamab treatment cycle.

DRUG

Carboplatin

Participants will receive carboplatin in combination with pemetrexed and Amivantamab as an IV infusion on 21-day treatment cycle in Part 1 Chemotherapy Combination Cohort only.

DRUG

Pemetrexed

Participants will receive pemetrexed in combination with carboplatin and Amivantamab as an IV infusion on 21-day treatment cycle in Part 1 Chemotherapy Combination Cohort only.

Trial Locations (69)

Unknown

Duarte

La Jolla

Orange

Santa Monica

West Hollywood

Tampa

Chicago

Bethesda

Boston

Detroit

Rochester

St Louis

New York

Portland

Philadelphia

Houston

Fairfax

Camperdown

Heidelberg

Kogarah

Murdoch

Woolloongabba

Toronto

Beijing

Changchun

Changsha

Chengdu

Chongqing

Guangzhou

Hangzhou

Hefei

Nanchang

Nanjing

Wuhan

Zhengzhou

Bordeaux

Dijon

Lyon

Marseille

Paris

Saint-Herblain

Villejuif

Chūōku

Hyōgo

Kashiwa

Kurume

Nagoya

Niigata

Osaka

Tokyo

Wakayama

Yonago

Cheongju-si

Goyang-si

Incheon

Seongnam-si

Seoul

A Coruña

Barcelona

Madrid

Málaga

Santander

Seville

Kaohsiung City

Taichung

Taipei

Manchester

Newcastle upon Tyne

Sutton

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY