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ACTIVE NOT RECRUITING
NCT02609776
PHASE1

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

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

The purpose of study is to evaluate the safety, pharmacokinetics, and preliminary efficacy of Amivantamab as a monotherapy and in combination with lazertinib, and to determine the recommended Phase 2 dose (RP2D) (monotherapy), recommended Phase 2 combination dose (RP2CD) (combination therapy), and to determine recommended Phase 2 Dose (RP2q3W) with combination chemotherapy (Amivantamab in combination with standard of care carboplatin and pemetrexed) in 21 day treatment cycle for participants with advanced non-small cell lung cancer (NSCLC).

Official title: A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-61186372, a Human Bispecific EGFR and cMet Antibody, in Subjects With Advanced Non-Small Cell Lung Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

751

Start Date

2016-05-24

Completion Date

2026-12-31

Last Updated

2026-01-16

Healthy Volunteers

No

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.

Locations (69)

Duarte, California, United States

La Jolla, California, United States

Orange, California, United States

Santa Monica, California, United States

West Hollywood, California, United States

Tampa, Florida, United States

Chicago, Illinois, United States

Bethesda, Maryland, United States

Boston, Massachusetts, United States

Detroit, Michigan, United States

Rochester, Minnesota, United States

St Louis, Missouri, United States

New York, New York, United States

Portland, Oregon, United States

Philadelphia, Pennsylvania, United States

Houston, Texas, United States

Fairfax, Virginia, United States

Camperdown, Australia

Heidelberg, Australia

Kogarah, Australia

Murdoch, Australia

Woolloongabba, Australia

Toronto, Ontario, Canada

Beijing, China

Changchun, China

Changsha, China

Chengdu, China

Chongqing, China

Guangzhou, China

Hangzhou, China

Hefei, China

Nanchang, China

Nanjing, China

Wuhan, China

Zhengzhou, China

Bordeaux, France

Dijon, France

Lyon, France

Marseille, France

Paris, France

Saint-Herblain, France

Villejuif, France

Chūōku, Japan

Hyōgo, Japan

Kashiwa, Japan

Kurume, Japan

Nagoya, Japan

Niigata, Japan

Osaka, Japan

Tokyo, Japan

Wakayama, Japan

Yonago, Japan

Cheongju-si, South Korea

Goyang-si, South Korea

Incheon, South Korea

Seongnam-si, South Korea

Seoul, South Korea

A Coruña, Spain

Barcelona, Spain

Madrid, Spain

Málaga, Spain

Santander, Spain

Seville, Spain

Kaohsiung City, Taiwan

Taichung, Taiwan

Taipei, Taiwan

Manchester, United Kingdom

Newcastle upon Tyne, United Kingdom

Sutton, United Kingdom