Clinical trials: Lazertinib
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
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
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
Lung Neoplasms
Lazertinib in Patients With NSCLC With Asymptomatic or Mild Symptomatic Brain Metastases After Failure of EGFR TKI.
This is an open-label, single-intervention, multicenter clinical trial in patients with non-small cell lung cancer with asymptomatic or mildly symptomatic brain metastases after failure of EGFR TKI treatment.
- Trial name
- NCT05326425
- Testing
- lazertinib(YH25448)
- Where
- 6 sites in South Korea
- Volunteers
- 40 people
- Sponsor
- Jin Hyoung Kang
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
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 (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
Healthy
A Study to Assess the Effects of Itraconazole and Rifampin on Lazertinib in Healthy Adult Participants
The purpose of this study is to evaluate the effects of multiple doses of strong cytochrome P450 (CYP) 3A4 inhibitor itraconazole and strong CYP3A4 inducer rifampin on the single dose pharmacokinetics (PK) of lazertinib in…
- Trial name
- NCT04410094
- Testing
- Lazertinib, Itraconazole, Rifampin
- Where
- United States
- Volunteers
- 32 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
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
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
Metastatic Non Small Cell Lung Cancer, Recurrent Non Small Cell Lung Cancer
A Study of Amivantamab and Lazertinib in People With Non-Small Cell Lung Cancer (NSCLC)
The researchers think that the study drugs, amivantamab and lazertinib, may be an effective treatment for people who have metastatic NSCLC with an EGFR mutation.
- Trial name
- NCT04965090
- Testing
- Amivantamab, Lazertinib
- Where
- 7 sites in United States
- Volunteers
- 43 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
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
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
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
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
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
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
Carcinoma, Non-Small-Cell Lung
A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
The primary purpose of the study is to assess how well amivantamab in combination with lazertinib or in combination with chemotherapy works (antitumor activity) in participants with epidermal growth factor receptor mutated…
- Trial name
- COPERNICUS (NCT06667076)
- Testing
- Amivantamab, Lazertinib, Chemotherapy: Pemetrexed
- Where
- 204 sites in United States, Belgium and 12 more
- Volunteers
- 480 people
- Sponsor
- Janssen Research & Development, LLC