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).
This open label (all participants know the identity of the study drug), multicenter (more
than one study site), first-in-human study consists of 2 parts. Part 1 is a Amivantamab
Monotherapy and Combination Dose Escalations and Part 2 Amivantamab Monotherapy and
Combination Dose Expansions. In Part 1, participants with evaluable NSCLC will be enrolled
into cohorts at increasing dose levels of Amivantamab monotherapy, the RP2CD of the
Amivantamab and lazertinib combination which will be administered in 28 day treatment cycles,
and RP2q3W of Amivantamab in combination with standard of care carboplatin and pemetrexed
(chemotherapy combination) which will be administered in 21 day treatment cycles. The dose
will be escalated until the maximum tolerated dose (MTD, or maximum administered dose [MAD],
if no MTD is found) is reached. Part 1 will follow a traditional 3+3 design. At each dose
level, 3 participants will complete Cycle 1. If no dose limiting toxicity (DLT) occurs in
these 3 participants, then escalation will continue in a new cohort of 3 participants. Data
from Part 1 will be used to determine one or more RP2D regimen(s). In Part 2, participants
with documented epidermal growth factor receptor (EGFR) mutations and measurable disease,
whose disease has progressed after previous treatment will be enrolled and receive
Amivantamab at the RP2D determined in Part 1 as a monotherapy at the RP2D regimen(s), or in
combination with lazertinib at the RP2CD regimen. For both parts, the study consists of
following periods: an optional pre-Screening period; a Screening period (up to 28 days prior
to the first dose of study drug); a Treatment period (first dose of study drug until 30(+7)
days after the last dose of study drug or prior to starting any subsequent anti-cancer
treatment, whichever comes first); and a Follow Up period (approximately 6 months). All
participants will be followed for survival in the post-treatment follow-up period until the
end of study and safety will be monitored throughout the study.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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