Clinical trials: Lazertinib
Healthy
A Study of Lazertinib (JNJ-73841937) in Healthy Participants
The purpose of this study is to evaluate the effect of steady-state concentrations of lazertinib on the single-dose pharmacokinetics (PK) of probe substrates (midazolam, rosuvastatin, and metformin) in healthy adult participants.
- Trial name
- NCT05076877
- Testing
- Lazertinib, Midazolam, Rosuvastatin
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Carcinoma, Non-Small-Cell Lung
Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib
The purpose of this study is to evaluate whether enhanced dermatologic management can reduce incidence of grade greater than or equal to (>=) 2 dermatologic adverse events of interest (DAEIs) when compared with standard-of-care…
- Trial name
- COCOON (NCT06120140)
- Testing
- Amivantamab IV, Amivantamab SC, Lazertinib
- Where
- 93 sites in United States, Argentina and 9 more
- Volunteers
- 305 people
- Sponsor
- Janssen Research & Development, LLC
Lung Cancer
Early Access Program of Lazertinib in Republic of Korea
This early access program will be conducted to provide access to Lazertinib for adult patients with locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) with T790M mutation-positive after 1st/2nd generation EGFR TKIs…
- Trial name
- NCT04829422
- Testing
- Lazertinib 240 mg
- Sponsor
- Yuhan Corporation
NSCLC
Lazertinib for NSCLC Harboring Activating EGFR Mutations in TKI naïve Patients
The primary objective is to evaluate the efficacy/safety of lazertinib and to explore the resistance mechanism of lazertinib as first-line in patients with NSCLC harboring activating EGFR mutations.
- Trial name
- NCT05463224
- Testing
- Lazertinib group
- Where
- South Korea
- Volunteers
- 150 people
- Sponsor
- Sehhoon Park
Carcinoma, Non-Small-Cell Lung
A Study of Lazertinib in Participants With Epidermal Growth Factor Receptor (EGFR) Mutation Positive Advanced Non-Small Cell Lung Cancer (NSCLC)
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+)…
- Trial name
- NCT04075396
- Testing
- Lazertinib
- Where
- 9 sites in United States, Spain and 1 more
- Volunteers
- 29 people
- Sponsor
- Janssen Research & Development, LLC
Hepatic Impairment, Healthy
A Study to Evaluate the Effect of Hepatic Impairment on Lazertinib (JNJ-73841937)
The purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose of lazertinib in participants with impaired hepatic function when compared with healthy participants with normal hepatic function, under fed…
- Trial name
- NCT05112952
- Testing
- Lazertinib
- Where
- 2 sites in Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Non Small Cell Lung Cancer
The Safety and Efficacy of First-line Lazertinib and Locally Ablative Radiotherapy in Patients With Synchronous Oligo-metastatic EGFR-mutant Non-small Cell Lung Cancer
This is based on the observations that disease progression under EGFR(Epidermal Growth Factor Receptor) targeting TKI(Tyrosine Kinase Inhibitor) most frequently occurs at the original sites of metastatic disease and that the…
- Trial name
- NCT05167851
- Testing
- Lazertinib , a combination group of SBRT, Lazertinib single administration group
- Where
- South Korea
- Volunteers
- 68 people
- Sponsor
- Yonsei University
Non Small Cell Lung Cancer
Amivantamab, Lazertinib and Bevacizumab in Patients With EGFR-mutant Advanced Non-small Cell Lung Cancer With Progression on Previous Third-generation EGFR-TKI
AMAZE-lung is a multicenter single-arm phase II trial. The protocol treatment consists of amivantamab, lazertinib and bevacizumab (Zirabev®), given in a three-weekly regimen.
- Trial name
- AMAZE-lung (NCT05601973)
- Testing
- Amivantamab, Lazertinib, Zirabev
- Where
- 18 sites in France, Italy and 4 more
- Volunteers
- 60 people
- Sponsor
- ETOP IBCSG Partners Foundation
Non-small Cell Lung Cancer
Retrospective, External Comparator Study of Lazertinib as the 2nd-Line Treatment in Patients With EGFR Mutation+ NSCLC
This retrospective, external comparator study for Lazertinib aims to assess the real-world effectiveness of Lazertinib as the second-line treatment versus platinum-based chemotherapy in patients with epidermal growth receptor…
- Trial name
- NCT05862194
- Testing
- Lazertinib, Platinum-based Chemotherapy
- Volunteers
- 534 people
- Sponsor
- Yuhan Corporation
Healthy
A Study of Lazertinib (JNJ-73841937) Tablet in Healthy Adult Participants
The purpose of this study is to assess the extent of availability of drug to the body of four different lazertinib tablet formulations at a single oral dose under fasted conditions in healthy adult participants.
- Trial name
- NCT05896683
- Testing
- Lazertinib
- Where
- Belgium
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
A Study of (14C)-JNJ-73841937 (Lazertinib) in Healthy Male Participants
The purpose of this study is to characterize the absorption, metabolic pathways of lazertinib, and the excretion of the parent lazertinib and its metabolites, after a single oral dose of 14C-lazertinib in healthy adult male…
- Trial name
- NCT04410081
- Testing
- 14C-lazertinib
- Where
- Netherlands
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Non Small Cell Lung Cancer
Neoadjuvant Lazertinib Therapy in EGFR-Mutation Positive Lung Adenocarcinoma Detected by BALF Liquid Biopsy
Complete surgical resection is the standard treatment in early-stage lung cancer. However, the patients with early resected Epidermal Growth Factor Receptor(EGFR)-mutated lung cancers have high recurrence rate.
- Trial name
- NCT05469022
- Testing
- Neoadjuvant lazertinib
- Where
- South Korea
- Volunteers
- 40 people
- Sponsor
- Konkuk University Medical Center
Advanced or Metastatic Non-small Cell Lung Cancer
A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer
The purpose of the study is to simplify amivantamab intravenous administration and to reduce dose times, by assessing a new formulation of amivantamab, amivantamab subcutaneous and co-formulated with recombinant human…
- Trial name
- PALOMA-3 (NCT05388669)
- Testing
- Lazertinib, Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF), Amivantamab Intravenous
- Where
- 187 sites in United States, Argentina and 18 more
- Volunteers
- 418 people
- Sponsor
- Janssen Research & Development, LLC
Lung Cancer Stage IV, EGFR T790M
Lazertinib 160mg in EGFR T790M NSCLC
The lazertinib is currently approved as 2nd line T790M mutation-positive NSCLC that failed from either 1st or 2nd generation EGFR TKI. The current recommended dosage is 240mg.
- Trial name
- NCT05701384
- Testing
- Lazertinib
- Where
- South Korea
- Volunteers
- 117 people
- Sponsor
- Samsung Medical Center
Non-Small Cell Lung Cancer Metastatic
Lazertinib & Tepotinib for EGFR Mutant NSCLC in MET Overexpressed or Amplified Who Progressed After Lazertinib Treatment
As the 3rd generation, EGFR TKI has become a standard treatment option for the 1st line therapy in EGFR mutated patients, the necessity for evaluating resistant mechanism to determine the matched subsequent therapeutic option has…
- Trial name
- NCT06106802
- Testing
- Lazertinib, Tepotinib
- Where
- South Korea
- Volunteers
- 47 people
- Sponsor
- Sehhoon Park
Carcinoma, Non-Small-Cell Lung
A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer
The purpose of this study is to confirm the tolerability of recommended Phase 2 dose (RP2D) of Lazertinib (Phase 1), to determine the tolerability and identify the recommended Phase 2 combination dose of Lazertinib when combined…
- Trial name
- Chrysalis-2 (NCT04077463)
- Testing
- Lazertinib, Amivantamab, Carboplatin
- Where
- 78 sites in United States, China and 8 more
- Volunteers
- 701 people
- Sponsor
- Janssen Research & Development, LLC
Non-Small Cell Lung Cancer
Clinical Trial of YH25448(Lazertinib) as the First-line Treatment in Patients With EGFR Mutation Positive Locally Advanced or Metastatic NSCLC (LASER301)
This Phase III study will be conducted to evaluate the efficacy and safety of YH25448 as first-line treatment in locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) patients with EGFR mutations
- Trial name
- NCT04248829
- Testing
- Lazertinib 240 mg/160 mg, Gefitinib 250 mg
- Where
- 80 sites in Australia, Greece and 11 more
- Volunteers
- 393 people
- Sponsor
- Yuhan Corporation
Carcinoma, Non-Small-Cell Lung
A Study of Neoadjuvant Amivantamab With Either Lazertinib or Chemotherapy in Participants With Resectable EGFR-Mutated NSCLC
The purpose of this study is to assess the ability to slow down or stop the growth of cancer with amivantamab combined with either lazertinib or chemotherapy (carboplatin and pemetrexed) in participants with resectable, epidermal…
- Trial name
- AmiNA (NCT07586202)
- Testing
- Amivantamab, Lazertinib, Carboplatin
- Where
- 23 sites in United States, Canada and 4 more
- Volunteers
- 68 people
- Sponsor
- Janssen Research & Development, LLC
Non-small Cell Lung Cancer
Lazertinib/Pemetrexed/Carboplatin After Osimertinib Failure in NSCLC With Brain Metastases
The primary objective is to evaluate the intracranial efficacy of pemetrexed/carboplatin chemotherapy and lazertinib combination therapy after osimertinib failure in EGFR-positive non-small cell lung cancer patients with brain…
- Trial name
- NCT05477615
- Testing
- Lazertinib, Pemetrexed, Carboplatin
- Where
- 6 sites in South Korea
- Volunteers
- 14 people
- Sponsor
- Jin Hyoung Kang