Clinical Trial

Treatment of Non-Small Cell Lung Cancer

Study Description

Study of JNJ-61186372, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer

The purpose of study is to evaluate the safety, pharmacokinetics, and preliminary efficacy of JNJ-61186372 as a monotherapy and in combination with lazertinib, and to determine the recommended Phase 2 dose (RP2D)(monotherapy) and recommended Phase 2 combination dose (RP2CD) (combination therapy) in participants with advanced non-small cell lung cancer (NSCLC).

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Recruiting patients only Recruiting patients only

Drug - JNJ-61186372

The first cohort of participants will receive IV infusions of JNJ-61186372 140 mg as monotherapy. Each subsequent cohort will receive IV infusions of JNJ-61186372 at increased dose level until maximum tolerated dose is reached or all planned doses are administered. Participants will receive lazertinib and JNJ-61186372 at predefined dose levels, based upon observed safety and protocol defined criteria. The duration of each treatment cycle is 28 days.

Drug - JNJ-61186372

Participants will receive IV infusion of JNJ-61186372 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 JNJ-61186372 at predefined dose levels, based upon observed safety and protocol defined criteria. Lazertinib will be administered daily on the 28-day JNJ-61186372 treatment cycle.

Additional Information

Official Study 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

Clinical Trial ID

NCT02609776

ParticipAid ID

Pe9GYb