Clinical trials: Lazertinib
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
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
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
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
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
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
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
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
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
Healthy Adult Volunteers
Clinical Trial to Assess Bioequivalence of Lazertinib Between Two Formulations in Healthy Volunteers.
This Clinical Trial is an open, randomized, fasted, single-dose, oral administration 2-sequence, 2-period crossover study to assess bioequivalence of lazertinib between two formulations in healthy adult volunteers.
- Trial name
- NCT05162274
- Testing
- Lazertinib(G001), Lazertinib(G002)
- Where
- South Korea
- Volunteers
- 38 people, healthy volunteers welcome
- 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
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
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