Janssen Research & Development, LLC Clinical Trial Study Director Janssen Research & Development, LLC
Kontakt
Study Contact Kontakt: Phone: 844-434-4210 E-Mail: Participate-In-This-Study@its.jnj.com» Kontaktdaten anzeigen
Studienlocations (3 von 78)
Evangelische Lungenklinik Berlin 13125 Berlin (Berlin) GermanyRekrutierend» Google-MapsUniversitaetsklinikum Essen 45147 Essen (Nordrhein-Westfalen) GermanyRekrutierend» Google-MapsKlinikum der Johann Wolfgang Goethe-Universität 60590 Frankfurt am Main (Hessen) GermanyAbgeschlossen» Google-Maps
Asklepios Klinik Gauting GmbH - Asklepios Fachkliniken Munchen-Gauting 82131 Gauting (Bayern) GermanyRekrutierend» Google-MapsStädtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH 06120 Halle (Saale) (Sachsen-Anhalt) GermanyAbgeschlossen» Google-MapsLungenklinik Hemer 58675 Hemer (Nordrhein-Westfalen) GermanyRekrutierend» Google-MapsLungenkrebszentrum Uniklinik Köln / Solingen Kerpener Straße 62 50937 Köln DeutschlandRekrutierend» Google-MapsKliniiken der Stadt Köln gGmbH, Krankenhaus Köln-Mehrheim 51109 Köln (Nordrhein-Westfalen) GermanyRekrutierend» Google-MapsPius-Hospital Oldenburg 26121 Oldenburg (Niedersachsen) GermanyRekrutierend» Google-MapsRobert-Bosch-Krankenhaus - Klinik Schillerhoehe 70376 Stuttgart (Baden-Württemberg) GermanyRekrutierend» Google-MapsUSC - Norris Comprehensive Cancer Center 90033 Los Angeles United StatesRekrutierend» Google-MapsUniversity of California Irvine 92868 Orange United StatesRekrutierend» Google-MapsUCSF Helen Diller Comprehensive 94158 San Francisco United StatesRekrutierend» Google-MapsStanford University Medical Center 94305 Stanford United StatesRekrutierend» Google-MapsCedars Sinai Medical Center 90048 West Hollywood United StatesRekrutierend» Google-MapsH. Lee Moffitt Cancer & Research Institute 33612 Tampa United StatesRekrutierend» Google-MapsMassachusetts General Hospital 02114 Boston United StatesRekrutierend» Google-MapsBoston University Medical Center 02118 Boston United StatesAbgeschlossen» Google-MapsDana Farber Cancer Institute 02215 Boston United StatesRekrutierend» Google-MapsBarbara Ann Karmanos Cancer Institute 48201 Detroit United StatesRekrutierend» Google-MapsWashington University School of Medicine 63110 Saint Louis United StatesRekrutierend» Google-MapsLangone Health at NYC University, NYU School of Medicine 10016 New York United StatesRekrutierend» Google-MapsColumbia University Medical Center 10032 New York United StatesRekrutierend» Google-MapsProvidence Portland Medical Center 97213 Portland United StatesRekrutierend» Google-MapsUniversity of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine 19104 Philadelphia United StatesRekrutierend» Google-MapsHuntsman Cancer Institute 84112 Salt Lake City United StatesRekrutierend» Google-MapsVirginia Cancer Specialists 22031 Fairfax United StatesRekrutierend» Google-MapsUniversity of Washington 98109 Seattle United StatesRekrutierend» Google-MapsBeijing Cancer Hospital 100142 Beijing ChinaRekrutierend» Google-MapsThe First Bethune Hospital of Jilin University 130021 Changchun ChinaRekrutierend» Google-MapsHunan Cancer hospital 410013 Changsha ChinaRekrutierend» Google-MapsWest China School of Medicine/West China Hospital, Sichuan University 610041 Chengdu ChinaRekrutierend» Google-MapsChongqing University Cancer Hospital 400030 Chongqing ChinaRekrutierend» Google-MapsThe Fifth Affiliated Hospital of Guangzhou Medical University 440112 Guangzhou ChinaRekrutierend» Google-MapsZhejiang Cancer Hospital 310022 Hang Zhou ChinaRekrutierend» Google-MapsCentral Hospital of Jinan 250013 Jinan ChinaRekrutierend» Google-MapsThe Second Affiliated Hospital of Kunming Medical University 650101 Kunming ChinaRekrutierend» Google-MapsShanghai Chest Hospital 200030 Shanghai ChinaRekrutierend» Google-MapsShengjing Hospital of China Medical University 110022 Shenyang ChinaAbgeschlossen» Google-MapsTianjin Medical University Cancer Institute and Hospital 300000 Tianjin ChinaRekrutierend» Google-MapsUnion Hospital Tongji Medical College of Huazhong University of Science and Technology 430022 Wuhan ChinaRekrutierend» Google-MapsThe First Affiliated Hospital of Xian Jiaotong University 710061 Xian ChinaRekrutierend» Google-MapsInstitut Bergonié 33000 Bordeaux FranceRekrutierend» Google-MapsCentre Leon Berard 69373 Lyon Cedex 8 FranceRekrutierend» Google-MapsCHU de la Timone 13005 Marseille FranceRekrutierend» Google-MapsInstitut Curie 75005 Paris FranceRekrutierend» Google-MapsCHU De Poitiers 86000 Poitiers FranceRekrutierend» Google-MapsHIA Begin 94163 Saint Mande FranceRekrutierend» Google-MapsInstitut Gustave Roussy 94805 Villejuif Cedex FranceRekrutierend» Google-MapsIRCCS Ospedale San Raffaele 20132 Milano ItalyRekrutierend» Google-MapsIRCCS Istituto Europeo di Oncologia Milano ItalyRekrutierend» Google-MapsSan Gerardo Hospital 20052 Monza ItalyRekrutierend» Google-MapsIstituto Nazionale Tumori Fondazione G. Pascale 80131 Napoli ItalyRekrutierend» Google-MapsOspedale S. Maria Delle Croci 48121 Ravenna ItalyRekrutierend» Google-MapsNational Cancer Center Hospital 104 0045 Chuo Ku JapanRekrutierend» Google-MapsKansai Medical University Hospital 573-1191 Hirakata JapanRekrutierend» Google-MapsKobe City Medical Center General Hospital 650-0047 Hyogo JapanRekrutierend» Google-MapsNational Cancer Center Hospital East 277 8577 Kashiwa JapanRekrutierend» Google-MapsAichi Cancer Center Hospital 464-8681 Nagoya-Shi JapanRekrutierend» Google-MapsOkayama University Hospital 700-8558 Okayama JapanRekrutierend» Google-MapsShizuoka Cancer Center 411-8777 Shizuoka JapanRekrutierend» Google-MapsSeoul National University Bundang Hospital 13620 Seongnam-si Korea, Republic ofRekrutierend» Google-MapsSeoul National University Hospital 03080 Seoul Korea, Republic ofRekrutierend» Google-MapsSeverance Hospital Yonsei University Health System 03722 Seoul Korea, Republic ofRekrutierend» Google-MapsSamsung Medical Center 06351 Seoul Korea, Republic ofRekrutierend» Google-MapsOncologic Hospital, Puerto Rico Medical Center OO935 Rio Piedras Puerto RicoRekrutierend» Google-MapsHosp. Univ. Quiron Dexeus 08028 Barcelona SpainRekrutierend» Google-MapsHosp. Univ. Vall D Hebron 8035 Barcelona SpainRekrutierend» Google-MapsHosp. Gral. Univ. Gregorio Maranon 28009 Madrid SpainRekrutierend» Google-MapsHosp. Univ. Ramon Y Cajal 28034 Madrid SpainRekrutierend» Google-MapsHosp. Univ. Fund. Jimenez Diaz 28040 Madrid SpainRekrutierend» Google-MapsHosp. Univ. 12 de Octubre 28041 Madrid SpainRekrutierend» Google-MapsHosp. Univ. Hm Sanchinarro 28050 Madrid SpainRekrutierend» Google-MapsHosp. Virgen Del Rocio 41013 Seville SpainRekrutierend» Google-MapsKaohsiung Medical University Chung-Ho Memorial Hospital 807 Kaohsiung TaiwanRekrutierend» Google-MapsChung Shan Medical University Hospital 402 Taichung TaiwanRekrutierend» Google-MapsNational Cheng Kung University Hospital 704 Tainan TaiwanRekrutierend» Google-MapsNational Taiwan University Hospital 10002 Taipei City TaiwanRekrutierend» Google-Maps
1. Percentage of Participants with Dose-Limiting Toxicity (DLT) (Phase 1) (Time Frame - Until the end of first cycle (21 days for Phase 1)): DLTs are defined as certain non-hematologic and hematologic toxicities of Grade 3 or higher.
2. Percentage of Participants with Dose-Limiting Toxicity (DLT) (Phase 1b) (Time Frame - Until the end of first cycle (28 days for Phase 1b)): DLTs are defined as certain non-hematologic and hematologic toxicities of Grade 3 or higher.
3. Overall Response Rate (ORR) (Phase 1b Expansion Cohorts A-D) (Time Frame - Up to 2.5 years): ORR is defined as the percentage of participants who achieve either a complete (CR) or partial response (PR) as determined by the investigator using RECIST 1.1 criteria.
4. Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability (Phase 1b Expansion Cohorts A-E) (Time Frame - Up to 2.5 years): Adverse events (AEs) defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Criteria Version 5.0 in participants treated at the RP2CD regimen of Lazertinib and Amivantamab combination therapy. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
5. Percentage of Participants with DLT (Phase 1b combination Lazertinib, Amivantamab, Platinum-doublet chemotherapy [LACP]) (Time Frame - Until the end of first cycle (21 days for Phase 1b combination LACP)): DLTs are defined as certain non-hematologic and hematologic toxicities of Grade 3 or higher.
6. Number of Participants with AEs as a Measure of Safety and Tolerability (Phase 1b combination LACP) (Time Frame - Up to 2.5 years): AEs defined by the NCI-CTCAE criteria version 5.0 in participants treated with LACP combination regimen. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
7. Overall Response Rate (ORR) per RECIST version 1.1 (v1.1) with NGS Analysis of Circulating Tumor ctDNA, IHC Analysis of EGFR and MET Expression (Phase 1b Expansion Cohort D) (Time Frame - Up to 2.5 years): ORR is defined as the percentage of participants who achieve either a complete (CR) or partial response (PR) as determined by the investigator using RECIST 1.1 criteria with Next Generation Sequencing (NGS) Analysis of Circulating Tumor Deoxyribonucleic Acid (ctDNA), Immunohistochemical (IHC) Analysis of Tumor Epidermal Growth Factor Receptor (EGFR) and MET Expression (Phase 1b Expansion Cohort D).
8. ORR Among Participants with MET3+ Staining on Greater Than or Equal to (>=)25 Percent (%) of Tumor Cells (Phase 1b Expansion Cohorts E and F) (Time Frame - Up to 2.5 years): ORR among participants with MET3+ staining on >=25 % of tumor cells will be reported. ORR is defined as the percentage of participants who achieve either a CR or PR as determined by the investigator using RECIST 1.1 criteria.
9. Duration of Response (DOR) Among Participants with MET3+ Staining on >=25% of Tumor Cells (Phase 1b Expansion Cohorts E and F) (Time Frame - Up to 2.5 years): DOR among participants with MET3+ staining on >=25 % of tumor cells will be reported. DOR will be calculated as time from initial response of CR or PR to progressive disease (PD) or death due to any cause, whichever comes first, only for participants who achieve CR or PR as determined by the investigator using RECIST 1.1 criteria.
10. Clinical Benefit Rate (CBR) Among Participants with MET3+ Staining on >=25% of Tumor Cells (Phase 1b Expansion Cohorts E and F) (Time Frame - Up to 2.5 years): CBR among participants with MET3+ staining on >=25% of tumor cells will be reported. CBR is defined as the percentage of participants achieving complete or partial response, or durable stable disease (duration of at least 11 weeks) as determined by the investigator using RECIST 1.1 criteria.
Secondary outcome:
1. Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability (Phase 1 and Phase 1b) (Time Frame - Up to 2.5 years): An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
2. Plasma Concentration of Lazertinib (Phase 1 and Phase 1b) (Time Frame - Up to End of Treatment [EOT]) (30 days after last dose) (up to 2.5 years)): Plasma samples will be analyzed to determine concentrations of Lazertinib.
3. Serum Concentration of Amivantamab (Phase 1b) (Time Frame - Up to EOT (30 days after last dose) (up to 2.5 years)): Serum samples will be analyzed to determine concentrations of Amivantamab.
4. Number of Participants with Anti-drug Antibodies Against Amivantamab (Phase 1b) (Time Frame - Up to EOT (30 days after last dose) (up to 2.5 years)): Number of participants with anti-drug antibodies against Amivantamab will be reported.
5. Progression free survival (PFS) (Phase 1b Expansion) (Time Frame - Up to 2.5 years): PFS is defined as the time from first infusion of study intervention to PD or death due to any cause.
6. Time to Treatment Failure (TTF) (Phase 1b Expansion) (Time Frame - Up to 2.5 years): TTF is defined as the time from the first administration of the study intervention to discontinuation of treatment for any reason, including disease progression, treatment toxicity, death, and will be utilized to capture clinical benefit for patients continuing treatment beyond as determined by the investigator using RECIST 1.1 criteria.
7. Overall Survival (OS) (Phase 1b Expansion) (Time Frame - Up to 2.5 years): OS is defined as the time from first infusion of study intervention to death due to any cause as determined by the investigator using RECIST 1.1 criteria.
8. Duration of Response (DOR) (Phase 1b expansion) (Time Frame - Up to 2.5 years): DOR will be calculated as time from initial response of CR or PR to progressive disease (PD) or death due to any cause, whichever comes first, only for participants who achieve CR or PR as determined by the investigator using RECIST 1.1 criteria.
9. Clinical Benefit Rate (CBR) (Phase 1b expansion) (Time Frame - Up to 2.5 years): CBR is defined as the percentage of participants achieving complete or partial response, or durable stable disease (duration of at least 11 weeks) as determined by the investigator using RECIST 1.1 criteria.
10. Number of Participants with Venous Thromboembolic (VTE) Events by Severity (Time Frame - Up to 2.5 years): Number of participants with VTE events including pulmonary embolism and deep vein thrombosis by severity defined by the NCI-CTCAE Criteria Version 5.0 will be reported.
11. Number of Participants with Adverse Events (AEs) (Phase 1b Expansion Cohort F) (Time Frame - Up to 2.5 years): An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
12. ORR (Phase 1b expansion Cohorts E and F) (Time Frame - Up to 2.5 years): ORR is defined as the percentage of participants who achieve either a CR or PR as determined by the investigator using RECIST 1.1 criteria.
13. DOR (Phase 1b Expansion Cohorts E and F) (Time Frame - Up to 2.5 years): DOR will be calculated as time from initial response of CR or PR to PD or death due to any cause, whichever comes first, only for participants who achieve CR or PR as determined by the investigator using RECIST 1.1 criteria.
14. CBR (Phase 1b expansion Cohorts E and F) (Time Frame - Up to 2.5 years): CBR is defined as the percentage of participants achieving complete or partial response, or durable stable disease (duration of at least 11 weeks) as determined by the investigator using RECIST 1.1 criteria.
15. Intracranial Progression free survival (PFS) (Phase 1b Expansion E and F) (Time Frame - Up to 2.5 years): Intracranial PFS is defined as the time from first infusion of study intervention until the date of objective intracranial disease progression or death, whichever comes first, based on Investigator assessment using RECIST v1.1.
Experimental: Phase 1 (monotherapy dose escalation): Lazertinib Participants will receive Lazertinib monotherapy orally once daily (QD) in 21-day cycles until documented evidence of disease progression, unacceptable toxicity, noncompliance, or withdrawal of consent, or the investigator decides to discontinue treatment, whichever comes first. The subsequent doses of Lazertinib will be assigned by the Study Evaluation Team (SET) according to the dose escalation strategy by Bayesian logistic regression model (BLRM).
Experimental: Phase 1b (combination): Lazertinib and Amivantamab Participants will receive Lazertinib and Amivantamab, after the safety of RP2D of Lazertinib is confirmed in the Phase 1, in 28-day cycles until documented evidence of disease progression, unacceptable toxicity, noncompliance, or withdrawal of consent, or the investigator decides to discontinue treatment, whichever comes first. This phase will start enrolling participants after the safety of Amivantamab is confirmed in Japanese participants in Study 61186372EDI1001 (NCT02609776).
Experimental: Phase 1b (combination): Lazertinib, Amivantamab and Platinum-doublet Chemotherapy (LACP) Participants will receive Lazertinib starting dose administered orally once daily (QD) in combination with Amivantamab, and doses of platinum-based chemotherapy (carboplatin and pemetrexed) per standard of care according to local guidance in a 21-day cycle for 4 cycles followed by maintenance with Lazertinib, Amivantamab and pemetrexed until disease progression or unacceptable toxicities.
Experimental: Phase 1b (expansion) Cohort A: Lazertinib and Amivantamab This cohort A will further characterize the safety, tolerability, and preliminary antitumor activity of Lazertinib and Amivantamab based combinations within specific NSCLC population "who have progressed after osimertinib and subsequent platinum-based chemotherapy, and platinum-based chemotherapy regimen as the last line of therapy prior to study enrollment. Prior use of first or second generation EGFR TKI is allowed if administered prior to osimertinib. Participants will receive at the RP2CD of Lazertinib orally QD and Amivantamab, every 7 days for the first 28 days cycle and every 2 weeks thereafter.
Experimental: Phase 1b (expansion) Cohort B: Lazertinib and Amivantamab This Cohort B will further characterize the safety, tolerability and preliminary antitumor activity of Lazertinib and JNJ-61186372 combination in participants previously treated with advanced or metastatic NSCLC with documented primary EGFR Exon 20ins activating mutation. Participants will receive at the RP2CD of Lazertinib orally QD and Amivantamab, every 7 days for the first 28 days cycle and every 2 weeks thereafter.
Experimental: Phase 1b (expansion) Cohort C: Lazertinib and Amivantamab This Cohort C will further characterize the safety, tolerability and preliminary antitumor activity of Lazertinib and JNJ-61186372 combination in participants with uncommon EGFR mutations. Participants will receive at the RP2CD of Lazertinib orally QD and Amivantamab, every 7 days for the first 28 days cycle and every 2 weeks thereafter.
Experimental: Phase 1b (expansion) Cohort D: Lazertinib and Amivantamab Cohort D will seek to validate one or both potential biomarker strategies (next generation sequencing [NGS] and Immunohistochemical [IHC]), previously identified in Cohort E of Study 61186372EDI1001, in participants with osimertinib-relapsed, but chemotherapy-naive, EGFR Exon19del or L858R mutated NSCLC. Participants will receive at the RP2CD of Lazertinib orally QD and Amivantamab, every 7 days for the first 28 days cycle and every 2 weeks thereafter.
Experimental: Phase 1b (expansion) Cohort E: Lazertinib and Amivantamab Participants will receive at the RP2CD of Lazertinib orally QD and Amivantamab, every 7 days for the first 28 days cycle and every 2 weeks thereafter. Cohort E will seek to validate the immunohistochemical (IHC)-based biomarker strategy, by characterizing the activity of Amivantamab and Lazertinib combination in biomarker-positive participants with osimertinib-relapsed, but chemotherapy-naïve, EGFR Exon19del or L858R mutated NSCLC. In addition, Cohort E will seek to collect prospective data to confirm that prophylactic anticoagulation safely and effectively decreases the incidence of VTE events for patients treated with the combination of Amivantamab and Lazertinib, using Cohort F as reference.
Experimental: Phase 1b (expansion) Cohort F: Amivantamab Monotherapy Participants will receive Amivantamab monotherapy once weekly (QW) for 4 weeks, then every 2 weeks thereafter. Cohort F will seek to validate the IHC-based biomarker strategy, previously identified in Cohort D, by characterizing the activity of JNJ-61186372 monotherapy (Cohort F) in biomarker-positive participants with osimertinib-relapsed, but chemotherapy-naïve, EGFR Exon19del or L858R mutated NSCLC.