| Lazcluze (lazertinib) / J&J |
2021-001825-33: A Clinical Study of Amivantamab and Lazertinib in Combination with Platinum-Based Chemotherapy Compared with Platinum-Based Chemotherapy in Patients with EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer After Osimertinib Failure |
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| Not yet recruiting | 3 | 690 | Europe, RoW | Amivantamab, Lazertinib, JNJ-61186372, JNJ-73841937/YH-25448, Solution for infusion, Tablet | Janssen-Cilag International NV, JANSSEN CILAG INTERNATIONAL NV, Janssen Research and Development, Janssen Cilag SpA | Locally Advanced or Metastatic Non-Small Cell Lung Cancer, A specific type of lung cancer called "Non-Small Cell Lung Cancer", Diseases [C] - Cancer [C04] | | | | |
| Active, not recruiting | 3 | 393 | Europe, RoW | Lazertinib 240 mg/160 mg, YH25448 240 mg/160 mg, Gefitinib 250 mg, Iressa 250 mg, Lazertinib-matching placebo 240 mg/160 mg, YH25448-matching placebo 240 mg/160 mg, Gefitinib-matching placebo 250 mg, Iressa-matching placebo 250 mg | Yuhan Corporation | Non-Small Cell Lung Cancer | 07/22 | 06/26 | | |
2022-000525-25: A Clinical Study of Lazertinib with Subcutaneous Amivantamab Administered via Manual Injection Compared with Intravenous Amivantamab or Amivantamab Subcutaneous On Body Delivery System in Patients with EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer After Progression on Osimertinib and Chemotherapy Uno studio clinico di lazertinib con amivantamab per via sottocutanea somministrato tramite iniezione manuale rispetto ad amivantamab per via endovenosa o ad amivantamab per via sottocutanea in pazienti con carcinoma polmonare non a piccole cellule avanzato o metastatico con mutazioni di EGFR dopo progressione durante il trattamento con osimertinib e chemioterapia |
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| Ongoing | 3 | 640 | Europe | Amivantamab (JNJ-61186372), Amivantamab (JNJ-61186372) co-formulated with recombinant human hyaluronidase (rHuPH20), Amivantamab JNJ-61186372 co-formulated with recombinant human hyaluronidase (rHuPH20) OBDS, Lazertinib mesylate monohydrate, [JNJ-61186372], [JNJ-73841937-ZCY/YH25448AM], Concentrate for solution for infusion, Concentrate for solution for injection/infusion, Film-coated tablet | JANSSEN CILAG INTERNATIONAL NV, Janssen-Cilag International NV, Janssen Research & Development, LLC | EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer carcinoma polmonare non a piccole cellule avanzato o metastatico con mutazioni di EGFR, A specific type of lung cancer called "Non-Small Cell Lung Cancer" carcinoma polmonare non a piccole cellule, Diseases [C] - Cancer [C04] | | | | |
MARIPOSA-2, NCT04988295: 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 |
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| Active, not recruiting | 3 | 776 | Europe, Canada, Japan, US, RoW | Lazertinib, JNJ-73841937, YH-25448, Amivantamab, JNJ-61186372, Pemetrexed, Carboplatin | Janssen Research & Development, LLC | Carcinoma, Non-Small-Cell Lung | 07/23 | 06/26 | | |
PALOMA-3, NCT05388669 / 2022-000525-25: 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 |
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| Active, not recruiting | 3 | 418 | Europe, Canada, Japan, US, RoW | Lazertinib, JNJ-73841937, YH25448, Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF), JNJ-61186372, Amivantamab Intravenous | Janssen Research & Development, LLC, Janssen Research & Development, LLC | Advanced or Metastatic Non-small Cell Lung Cancer | 01/24 | 12/25 | | |
| Active, not recruiting | 3 | 1074 | Europe, Canada, Japan, US, RoW | Amivantamab, JNJ-61186372, Osimertinib, Lazertinib, JNJ-73841937 and YH-25448, Placebo | Janssen Research & Development, LLC | Carcinoma, Non-Small-Cell Lung | 08/23 | 06/27 | | |
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2021-002337-42: A clinical study exploring the effect of amivantamab and lazertinib plus bevacizumab treatment, in people diagnosed with advanced non-small cell lung cancer (NSCLC) that shows a change (mutation) in the EGFR gene and has spread to other parts of the body during or after treatment with osimertinib or lazertinib. Un estudio clínico que explora el efecto del tratamiento con amivantamab y lazertinib más bevacizumab, en personas diagnosticadas con cáncer de pulmón de células no pequeñas (CPCNP) avanzado que muestra un cambio (mutación) en el gen EGFR y se ha diseminado a otras partes del cuerpo durante o después del tratamiento con osimertinib o lazertinib. |
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| Ongoing | 2 | 60 | Europe | Amivantamab, Lazertinib, Concentrate for solution for infusion, Film-coated tablet, Zirabev | ETOP IBCSG Partners Foundation, Janssen Pharmaceutica | patients with EGFR-mutant advanced NSCLC with progression on previous third generation EGFR TKI Pacientes con NSCLC avanzado con mutación de EGFR con progresión en TKI de EGFR de tercera generación anterior, Patients with non-small cell lung cancer that:• Has a change (mutation) in a gene called EGFR• Has spread to other parts of the body during, or after treatment with osimertinib or lazertinib. Pacientes con cáncer de pulmón de células no pequeñas:• Con mutación en un gen llamado EGFR• Se ha propagado a otras partes del cuerpo durante/ después del tratamiento con osimertinib o lazertinib, Diseases [C] - Cancer [C04] | | | | |
2022-000526-21: A Phase 2, Open-Label, Parallel Cohort Study of Subcutaneous Amivantamab in Multiple Regimens in Patients with Advanced or Metastatic Solid Tumors including EGFR-mutated Non-Small Cell Lung Cancer. Estudio en fase II abierto y de cohortes paralelas de amivantamab subcutáneo con diversas pautas posológicas en pacientes con tumores sólidos avanzados o metastásicos, incluido el cáncer de pulmón no microcítico con mutaciones en el gen EGFR. |
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| Not yet recruiting | 2 | 260 | Europe | Lazertinib, Amivantamab co-formulated with recombinant human hyaluronidase (rHuPH20), JNJ-73841937-ZCY/YH25448AM, JNJ-61186372, Film-coated tablet, Solution for injection | Janssen-Cilag International NV, JANSSEN CILAG INTERNATIONAL NV, Janssen Research and Development, Janssen Cilag SpA | Advanced or Metastatic Solid Tumors including EGFR-mutated Non-Small Cell Lung Cancer. Tumores sólidos avanzados o metastásicos, incluido el cáncer de pulmón no microcítico con mutaciones en el gen EGFR., Advanced or Metastatic Solid Tumors including EGFR-mutated Non-Small Cell Lung Cancer. Tumores sólidos avanzados o metastásicos, incluido el cáncer de pulmón no microcítico con mutaciones en el gen EGFR., Diseases [C] - Cancer [C04] | | | | |
2022-000974-25: Evaluation of Amivantamab Infusion Related Reaction Mitigation Evaluación de la Mitigación de las Reacciones Relacionadas con la Infusión de Amivantamab. |
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| Not yet recruiting | 2 | 120 | Europe | Lazertinib mesylate monohydrate, Amivantamab, Dexamethasone, Montelukast Sodium, Methotrexate, JNJ-73841937-ZCY/YH25448AM, JNJ-61186372, Film-coated tablet, Concentrate for solution for infusion, Tablet, Injection, Dexamethasone, Montelukast Sodium, Methotrexate | Janssen-Cilag International NV, Janssen Research & Development, LLC | EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer Mutación del EGFR en Cáncer de Pulmón No Microcítico avanzado o metastásico, A specific type of lung cancer called "Non-Small Cell Lung Cancer Tipo específico de Cáncer de Pulmón llamado "Cáncer de Pulmón No Microcítico", Diseases [C] - Cancer [C04] | | | | |
NCT05477615: Lazertinib/Pemetrexed/Carboplatin After Osimertinib Failure in NSCLC With Brain Metastases |
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| Not yet recruiting | 2 | 28 | RoW | Lazertinib, YH25448, Pemetrexed, Carboplatin | Jin Hyoung Kang, Korea University Anam Hospital | Non-small Cell Lung Cancer | 06/23 | 06/25 | | |
NCT06156527: A Randomized Phase II Study of LAZE rtiNib Alone Versus Lazertinib Plus bevaCizumab for NSCLC With EGFR + & Smoker |
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| Recruiting | 2 | 120 | RoW | Lazertinib, Single arm, combinationarm, Bevacizumab Injectable Product | National Cancer Center, Korea | Lazertinib | 09/26 | 12/26 | | |
| Not yet recruiting | 2 | 117 | RoW | Lazertinib | Samsung Medical Center | Lung Cancer Stage IV, EGFR T790M | 01/24 | 01/25 | | |
NeoLazer, NCT06268210: Neoadjuvant Lazertinib With or Without Chemotherapy for Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer |
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| Not yet recruiting | 2 | 160 | RoW | Lazertinib+Pemetrexed+Carboplatin, Lazertinib | Yonsei University | Non-small Cell Lung Cancer | 06/26 | 06/28 | | |
NCT05469022: Neoadjuvant Lazertinib Therapy in EGFR-Mutation Positive Lung Adenocarcinoma Detected by BALF Liquid Biopsy |
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| Recruiting | 2 | 40 | RoW | Neoadjuvant lazertinib, Neoadjuvant LECLAZA | Konkuk University Medical Center, Yuhan Corporation | Non Small Cell Lung Cancer | 05/24 | 05/27 | | |
PALOMA-2, NCT05498428: A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer |
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| Recruiting | 2 | 390 | Europe, Japan, US, RoW | Amivantamab, JNJ-61186372, Lazertinib, JNJ-73841937; YH25448, Carboplatin, Pemetrexed, Direct Oral Anticoagulant (DOAC), Low Molecular Weight Heparin (LMWH) | Janssen Research & Development, LLC | Carcinoma, Non-small-Cell Lung | 10/25 | 08/26 | | |
NCT05326425: Lazertinib in Patients With NSCLC With Asymptomatic or Mild Symptomatic Brain Metastases After Failure of EGFR TKI. |
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| Recruiting | 2 | 40 | RoW | lazertinib(YH25448) | Jin Hyoung Kang | Lung Neoplasms | 06/24 | 06/24 | | |
NCT04965090: A Study of Amivantamab and Lazertinib in People With Non-Small Cell Lung Cancer (NSCLC) |
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| Active, not recruiting | 2 | 43 | US | Amivantamab, Lazertinib | Memorial Sloan Kettering Cancer Center, Janssen Scientific Affairs, LLC | Metastatic Non Small Cell Lung Cancer, Recurrent Non Small Cell Lung Cancer | 07/26 | 07/26 | | |
CHAMELEON, NCT06020989: Lazertinib and Chemotherapy Combination in EGFR-mutant NSCLC Patients Without ctDNA Clearance After lead-in Lazertinib Monotherapy |
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| Not yet recruiting | 2 | 129 | RoW | Lazertinib+Pemetrexed+Carboplatin, Lazertinib | Yonsei University | Non Small Cell Lung Cancer | 09/24 | 12/25 | | |
| Not yet recruiting | 2 | 36 | RoW | Lazertinib | Yonsei University | NSCLC | 12/24 | 12/24 | | |
LUCAS, NCT05786430: Lazertinib+Pemetrexed/Carboplatin in Patients With EGFR Sensitizing Mutation Positive Recurrent or Metastatic Non-Small Cell Lung Cancer Failed to Prior Lazertinib |
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| Not yet recruiting | 2 | 87 | RoW | Lazertinib/Pemetrexed/Carboplatin | Yonsei University | Non-small Cell Lung Cancer | 12/24 | 12/25 | | |
| Active, not recruiting | 2 | 73 | Europe, US, RoW | Dexamethasone, Montelukast, Methotrexate, Amivantamab, JNJ-61186372, Lazertinib, JNJ-73841937 | Janssen Research & Development, LLC | Carcinoma, Non-Small-Cell Lung | 03/24 | 10/25 | | |
COPERNICUS, NCT06667076: 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) |
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| Recruiting | 2 | 365 | US | Amivantamab, JNJ-61186372, Lazertinib, JNJ-73841937, Chemotherapy: Pemetrexed, Chemotherapy: Carboplatin | Janssen Research & Development, LLC | Carcinoma, Non-Small-Cell Lung | 05/29 | 05/29 | | |
NCT05463224: Lazertinib for NSCLC Harboring Activating EGFR Mutations in TKI naïve Patients |
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| Active, not recruiting | 2 | 150 | RoW | Lazertinib group | Myung-Ju Ahn | NSCLC | 03/25 | 07/25 | | |
COCOON, NCT06120140: 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 |
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| Recruiting | 2 | 200 | Europe, US, RoW | Amivantamab IV, JNJ-61186372, Amivantamab SC, Lazertinib, JNJ-73841937, Doxycycline, Minocycline, Clindamycin, Chlorhexidine, Noncomedogenic skin moisturizer, Ruxolitinib, Tacrolimus | Janssen Research & Development, LLC | Carcinoma, Non-Small-Cell Lung | 11/25 | 03/26 | | |
NCT05167851: 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 |
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| Not yet recruiting | 2 | 68 | RoW | Lazertinib , a combination group of SBRT, Lazertinib single administration group | Yonsei University | Non Small Cell Lung Cancer | 12/25 | 12/25 | | |
PLATINUM, NCT05338619: A Study of Lazertinib as Consolidation Therapy in Patients With Locally Advanced, Unresectable, EGFR-Mutant Non-Small Cell Lung Cancer (Stage III) Following Chemoradiation Therapy |
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| Recruiting | 2 | 77 | RoW | Lazertinib, LECLAZA | Sung Yong Lee, Yuhan Corporation | Non-small Cell Lung Cancer Stage III, EGFR Positive Non-small Cell Lung Cancer, Non-squamous Non-small-cell Lung Cancer | 03/26 | 03/26 | | |
| Recruiting | 2 | 60 | Europe | Amivantamab, Lazertinib, Zirabev | ETOP IBCSG Partners Foundation, Janssen Pharmaceuticals | Non Small Cell Lung Cancer | 03/26 | 09/26 | | |
AMIGO-1, NCT05299125: Amivantamab, Lazertinib, and Pemetrexed for First-line Treatment of Recurrent/Metastatic Non-small Cell Lung Cancers With Epidermal Growth Factor Receptor Mutations |
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| Active, not recruiting | 2 | 54 | RoW | Amivantamab, Lazertinib, Pemetrexed 500 mg | Latin American Cooperative Oncology Group, Janssen, LP | Metastatic Non-small Cell Lung Cancers | 01/26 | 07/27 | | |
NCT06106802: Lazertinib & Tepotinib for EGFR Mutant NSCLC in MET Overexpressed or Amplified Who Progressed After Lazertinib Treatment |
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| Not yet recruiting | 2 | 47 | RoW | Lazertinib, Tepotinib | Samsung Medical Center | Non-Small Cell Lung Cancer Metastatic | 09/29 | 09/29 | | |
NCT03046992: Clinical Trial of YH25448 in Patients With EGFR Mutation Positive Advanced NSCLC |
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| Active, not recruiting | 1/2 | 230 | RoW | YH25448 | Yuhan Corporation | EGFR Gene Mutation | 09/22 | 12/22 | | |
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NCT05742594: A Study of Four Different Oral Tablet Formulations of Lazertinib (JNJ-73841937) in Healthy Adult Participants |
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| Completed | 1 | 64 | US | Lazertinib, JNJ-73841937 | Janssen Research & Development, LLC | Healthy | 03/23 | 04/23 | | |
NCT05896683: A Study of Lazertinib (JNJ-73841937) Tablet in Healthy Adult Participants |
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| Completed | 1 | 72 | Europe | Lazertinib, JNJ-73841937 | Janssen Research & Development, LLC | Healthy | 09/23 | 09/23 | | |
CHRYSALIS, NCT02609776: Study of Amivantamab, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer |
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| Active, not recruiting | 1 | 751 | Europe, Canada, Japan, US, RoW | Amivantamab, JNJ-61186372, Lazertinib, JNJ-73841937, YH25448, Carboplatin, Pemetrexed | Janssen Research & Development, LLC | Non-Small-Cell Lung Cancer | 01/24 | 06/25 | | |
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PALOMA, NCT04606381: A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies |
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| Active, not recruiting | 1 | 159 | Europe, Canada, US, RoW | Ami-LC-MD, Ami-LC, Ami-HC, Ami-HC-CF, Lazertinib, JNJ-73841937, YH25448 | Janssen Research & Development, LLC | Advanced Solid Malignancies | 07/24 | 10/25 | | |
CHRYSALIS-2, NCT04077463: A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer |
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| Active, not recruiting | 1 | 701 | Europe, Japan, US, RoW | Lazertinib, JNJ-73841937, Amivantamab, JNJ-61186372, Carboplatin, Pemetrexed | Janssen Research & Development, LLC | Carcinoma, Non-Small-Cell Lung | 06/26 | 06/26 | | |
NCT05862194: Retrospective, External Comparator Study of Lazertinib as the 2nd-Line Treatment in Patients With EGFR Mutation+ NSCLC |
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| Completed | N/A | 534 | NA | Lazertinib, YH25448, Platinum-based Chemotherapy, External Control | Yuhan Corporation | Non-small Cell Lung Cancer | 04/22 | 03/23 | | |
NCT05377788: Lazertinib Real-world Observational Study of in Pre-treated EGFR T790M Mutant With Advanced Non-small Cell Lung Cancer |
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| Not yet recruiting | N/A | 900 | RoW | Lazertinib, LECLAZA | Samsung Medical Center | Metastatic Lung Non-Small Cell Carcinoma, EGFR T790M | 06/24 | 06/24 | | |
NCT05716672: Impact of Lazertinib Dose Modification on Effectiveness and Safety |
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| Not yet recruiting | N/A | 200 | RoW | Lazertinib, LECLAZA | Pusan National University Hospital, Yuhan Corporation | Non-small Cell Lung Cancer | 12/25 | 12/25 | | |
