Clinical trials: Lazertinib
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
Carcinoma, Non-Small-Cell Lung
A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure
The purpose of this study is to assess the efficacy of adding lazertinib to amivantamab, carboplatin, and pemetrexed (LACP/ACP-L dosing strategies) and amivantamab, carboplatin and pemetrexed (ACP) compared with carboplatin and…
- Trial name
- MARIPOSA-2 (NCT04988295)
- Testing
- Lazertinib, Amivantamab, Pemetrexed
- Where
- 249 sites in United States, Argentina and 27 more
- Volunteers
- 776 people
- Sponsor
- Janssen Research & Development, LLC
Non-small Cell Lung Cancer
Lazertinib+Pemetrexed/Carboplatin in Patients With EGFR Sensitizing Mutation Positive Recurrent or Metastatic Non-Small Cell Lung Cancer Failed to Prior Lazertinib
This trial is Phase II Trial of Lazertinib+Pemetrexed/Carboplatin in Patients with EGFR Sensitizing Mutation Positive Recurrent or Metastatic Non-Small Cell Lung Cancer Failed to prior lazertinib.
- Trial name
- LUCAS (NCT05786430)
- Testing
- Lazertinib/Pemetrexed/Carboplatin
- Where
- South Korea
- Volunteers
- 65 people
- Sponsor
- Yonsei University
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
Carcinoma, Non-Small-Cell Lung
A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
The purpose of this study is to assess the efficacy of the amivantamab and lazertinib combination, compared with osimertinib, in participants with epidermal growth factor receptor (EGFR) mutation (Exon 19 deletions [Exon 19del]…
- Trial name
- MARIPOSA (NCT04487080)
- Testing
- Amivantamab, Osimertinib, Lazertinib
- Where
- 269 sites in United States, Argentina and 26 more
- Volunteers
- 1,074 people
- 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
Healthy
A Study of Four Different Oral Tablet Formulations of Lazertinib (JNJ-73841937) in Healthy Adult Participants
The purpose of this study is to assess the bioequivalence of four different lazertinib oral tablet formulations in healthy adult participants under fasted condition.
- Trial name
- NCT05742594
- Testing
- Lazertinib
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Non Small Cell Lung Cancer
Collaborative Clinical-translational Cohort of Amivantamab Plus Lazertinib and Amivantamab Plus Chemotherapy in Patients With EGFR-mutant, Locally Advanced or Metastatic/Recurrent Non-Small Cell Lung Cancer (INSTAR Study)
In this study, we hypothesized that immune engagement by amivantamab will enhance antitumor efficacy by modulating the immune microenvironment in combination with lazertinib in patients with untreated EGFR-mutant NSCLC or with…
- Trial name
- INSTAR (NCT07507188)
- Testing
- Amivantamab SC + Lazertinib PO, Amivantamab SC + Chemotherapy (Carboplatin IV & Pemetrexed IV)
- Volunteers
- 80 people
- Sponsor
- Yonsei University
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 With or Without Chemotherapy for Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer
In the randomized, multicenter Phase II clinical trial, we aim to evaluate the efficacy and safety of Lazertinib monotherapy or the combination of Lazertinib and cytotoxic chemotherapy as neoadjuvant therapy in patients with…
- Trial name
- NeoLazer (NCT06268210)
- Testing
- Lazertinib+Pemetrexed+Carboplatin, Lazertinib
- Where
- South Korea
- Volunteers
- 160 people
- Sponsor
- Yonsei University
Metastatic Non-small Cell Lung Cancers
Amivantamab, Lazertinib, and Pemetrexed for First-line Treatment of Recurrent/Metastatic Non-small Cell Lung Cancers With Epidermal Growth Factor Receptor Mutations
This is a phase II, single-arm, multicenter trial, conducted through Latin American Coorperative Oncology Group (LACOG). Treatment-naïve patients with recurrent/metastatic NSCLCs harboring EGFR exon 19 deletions or exon 21 L858R…
- Trial name
- AMIGO-1 (NCT05299125)
- Testing
- Amivantamab, Lazertinib, Pemetrexed 500 mg
- Where
- 13 sites in Brazil
- Volunteers
- 54 people
- Sponsor
- Latin American Cooperative Oncology Group
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
Non-small Cell Lung Cancer
Impact of Lazertinib Dose Modification on Effectiveness and Safety
The primary objective is to evaluate Progression Free Survival (PFS) of the group (160 mg group) in which dose reduction was performed for 12 weeks after the first administration of Lazertinib.
- Trial name
- NCT05716672
- Testing
- Lazertinib
- Where
- 11 sites in South Korea
- Volunteers
- 200 people
- Sponsor
- Pusan National University Hospital
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
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
NSCLC (Advanced Non-small Cell Lung Cancer), VTE (Venous Thromboembolism)
A Clinical Trial on the Outcomes of Comprehensive Enhanced Prophylaxis Management (CEPM) in Chinese Patients With EGFR-Mutated Advanced NSCLC Receiving Amivantamab-Based Regimens
This study aims to explore the clinical outcomes of Comprehensive Enhanced Preventive Management (CEPM) combined with an amivantamab-containing treatment regimen in Chinese patients with EGFR-mutated advanced NSCLC.
- Conditions
- NSCLC (Advanced Non-small Cell Lung Cancer), VTE (Venous Thromboembolism), Rash Due to Epidermal Growth Factor Receptor Inhibitors, Infusion Reaction
- Trial name
- AmiCARE (NCT07469488)
- Testing
- Enhanced dermatologic management, Enhanced IRR Prophylaxis, Enhanced VTE Prophylaxis (Cohort 1 only)
- Where
- China
- Volunteers
- 122 people
- Sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
Metastatic Lung Non-Small Cell Carcinoma, EGFR T790M
Lazertinib Real-world Observational Study of in Pre-treated EGFR T790M Mutant With Advanced Non-small Cell Lung Cancer
It is to evaluate the safety and effectiveness of a lasertinib(LECLAZA) single drug in a actual medical environment for patients 1. Primary Purpose: Progression-free survival (PFS) 2.
- Trial name
- NCT05377788
- Testing
- Lazertinib
- Where
- South Korea
- Volunteers
- 900 people
- Sponsor
- Samsung Medical Center
Lazertinib
A Randomized Phase II Study of LAZE rtiNib Alone Versus Lazertinib Plus bevaCizumab for NSCLC With EGFR + & Smoker
Using gefitinib or Osimertinib, an EGFR tyrosine kinase inhibitor (TKI), in patients with active mutations in epithelial cell growth factor receptors (EGFR), 70% response rate (CR+PR) and 90% disease control rate (CR+PR+SD)…
- Trial name
- NCT06156527
- Testing
- Lazertinib, Bevacizumab Injectable Product
- Where
- 5 sites in South Korea
- Volunteers
- 120 people
- Sponsor
- National Cancer Center, Korea
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
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