A Study of Lazertinib in Participants With Epidermal Growth Factor Receptor (EGFR) Mutation Positive Advanced Non-Small Cell Lung Cancer (NSCLC)

Part of paid clinical trials in Duarte, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT04075396
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lazertinib — DRUG
    Participants will receive Lazertinib tablets once daily.

Study Details

The main purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of Lazertinib when given orally to participants with epidermal growth factor receptor single activating mutation positive (EGFRm+) locally advanced or metastatic Non Small Cell Lung Cancer (NSCLC).

Key Dates

Start date
Oct 16, 2019
Status verified
Apr 2025
Primary completion
Jan 8, 2021
Completion
Nov 14, 2022

Study Design

Enrollment
29 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part D: Outside of Korea
    Participants from outside of Korea with progressive disease and on prior epidermal growth factor receptor (EGFR) Tyrosine kinase inhibitor (TKI) therapy will receive recommended phase 2 doses based on safety, tolerability, efficacy and pharmacokinetics (PK) of Lazertinib.

Primary Outcome Measure

Part D: Number of Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: From Day 1 up to 14 months ]

Locations (5)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
Advent Health OrlandoOrlandoFlorida32804-
Moffitt Cancer CenterTampaFlorida33612-
Montefiore Medical CenterThe BronxNew York10461-
Tennessee OncologyNashvilleTennessee37211-

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CAAdvent Health Orlando· Orlando, FLMoffitt Cancer Center· Tampa, FLMontefiore Medical Center· The Bronx, NYTennessee Oncology· Nashville, TN

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