JOURNAL ONKOLOGIE – STUDIE
A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer
Rekrutierend
NCT-Nummer:
NCT04077463
Studienbeginn:
September 2019
Letztes Update:
26.02.2021
Wirkstoff:
Lazertinib, Amivantamab
Indikation (Clinical Trials):
Carcinoma, Non-Small-Cell Lung
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
Phase 1
Sponsor:
Janssen Research & Development, LLC
Collaborator:
-
Studienleiter
Study Director
Janssen Research & Development, LLC
Kontakt
Kontakt:
Phone: 844-434-4210
E-Mail: JNJ.CT@sylogent.com» Kontaktdaten anzeigen
Studienlocations (3 von 80)
Evangelische Lungenklinik Berlin
13125 Berlin
(Berlin)
GermanyRekrutierend» Google-MapsUniversitaetsklinikum Essen
45147 Essen
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-MapsKlinikum der Johann Wolfgang Goethe-Universität
60590 Frankfurt am Main
(Hessen)
GermanyNoch nicht rekrutierend» Google-Maps
13125 Berlin
(Berlin)
GermanyRekrutierend» Google-MapsUniversitaetsklinikum Essen
45147 Essen
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-MapsKlinikum der Johann Wolfgang Goethe-Universität
60590 Frankfurt am Main
(Hessen)
GermanyNoch nicht rekrutierend» Google-Maps
Asklepios Klinik Gauting GmbH - Asklepios Fachkliniken München-Gauting
82131 Gauting
(Bayern)
GermanyRekrutierend» Google-MapsStädtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH
06120 Halle (Saale)
(Sachsen-Anhalt)
GermanyRekrutierend» Google-MapsThoraxklinik am Universitätsklinikum Heidelberg
69126 Heidelberg
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-MapsLungenklinik Hemer
58675 Hemer
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-MapsLungenkrebszentrum Uniklinik Köln / Solingen
Kerpener Straße 62
50937 Köln
DeutschlandNoch nicht rekrutierend» Google-MapsKliniiken der Stadt Köln gGmbH, Krankenhaus Köln-Mehrheim
51109 Köln
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» 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
90089-9173 Los Angeles
United StatesNoch nicht rekrutierend» Google-MapsUniversity of California, Irvine
92868 Orange
United StatesNoch nicht rekrutierend» Google-MapsStandford University
94304 Palo Alto
United StatesNoch nicht rekrutierend» Google-MapsUCSF Helen Diller Comprehensive
94158 San Francisco
United StatesNoch nicht rekrutierend» Google-MapsCedars Sinai Medical Center
90048 West Hollywood
United StatesNoch nicht rekrutierend» Google-MapsMayo Clinic
32224 Jacksonville
United StatesZurückgezogen» Google-MapsH. Lee Moffitt Cancer & Research Institute
33612 Tampa
United StatesNoch nicht rekrutierend» Google-MapsMassachusetts General Hospital
02114 Boston
United StatesNoch nicht rekrutierend» Google-MapsBoston University Medical Center
02118 Boston
United StatesRekrutierend» Google-MapsDana Farber Cancer Institute
02215 Boston
United StatesNoch nicht rekrutierend» Google-MapsBarbara Ann Karmanos Cancer Institute
48201 Detroit
United StatesRekrutierend» Google-MapsMayo Clinic
55905 Rochester
United StatesZurückgezogen» 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 StatesNoch nicht rekrutierend» Google-MapsVirginia Cancer Specialists
22031 Fairfax
United StatesRekrutierend» Google-MapsUniversity of Washington
98109 Seattle
United StatesNoch nicht rekrutierend» Google-MapsBeijing Cancer Hospital
100142 Beijing
ChinaNoch nicht rekrutierend» Google-MapsThe First Bethune Hospital of Jilin University
130021 Changchun
ChinaRekrutierend» Google-MapsHunan Cancer hospital
410013 Changsha
ChinaNoch nicht rekrutierend» Google-MapsWest China School of Medicine/West China Hospital, Sichuan University
610041 Chengdu
ChinaRekrutierend» Google-MapsChongqing Cancer hospital
400030 Chongqing
ChinaRekrutierend» Google-MapsThe Fifth Affiliated Hospital of Guangzhou Medical University
440112 Guangzhou
ChinaRekrutierend» Google-MapsZhejiang Cancer Hospital
310022 Hang Zhou
ChinaNoch nicht rekrutierend» Google-MapsCentral Hospital of Jinan
250013 Jinan
ChinaRekrutierend» Google-MapsThe First Affiliated Hospital of NanChang University
330006 Nanchang
ChinaNoch nicht rekrutierend» Google-MapsShanghai Chest Hospital
200030 Shanghai
ChinaRekrutierend» Google-MapsShengjing Hospital of China Medical University
110022 Shenyang
ChinaNoch nicht rekrutierend» Google-MapsTianjin Medical University Cancer Institute and Hospital
300000 Tianjin
ChinaNoch nicht rekrutierend» Google-MapsUnion Hospital Tongji Medical College of Huazhong University of Science and Technology
430022 Wuhan
ChinaNoch nicht rekrutierend» Google-MapsFirst Affiliated Hospital, Xi'an Jiaotong University
710061 Xi'an
ChinaRekrutierend» Google-MapsInstitut Bergonié
33000 Bordeaux
FranceRekrutierend» Google-MapsCentre Leon Bérard
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 Istituto Europeo di Oncologia
Milano
ItalyRekrutierend» Google-MapsIstituto Nazionale Tumori Fondazione G. Pascale
80131 Napoli
ItalyRekrutierend» Google-MapsOspedale S. Maria Delle Croci
48121 Ravenna
ItalyNoch nicht rekrutierend» Google-MapsNational Cancer Center Hospital
104-0045 Chuo-Ku
JapanRekrutierend» Google-MapsKansai Medical University Hospital
573-1191 Hirakata
JapanRekrutierend» Google-MapsNational Cancer Center Hospital East
277-8577 Kashiwa
JapanRekrutierend» Google-MapsKobe City Medical Center General Hospital
650-0047 Kobe-City,
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 Sunto-gun
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
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-MapsInst. Cat. Doncologia-H Duran I Reynals
08908 Hospitalet de Llobregat, Barcelona
SpainZurückgezogen» Google-MapsHosp. Gral. Univ. Gregorio Marañon
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
Alle anzeigen 82131 Gauting
(Bayern)
GermanyRekrutierend» Google-MapsStädtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH
06120 Halle (Saale)
(Sachsen-Anhalt)
GermanyRekrutierend» Google-MapsThoraxklinik am Universitätsklinikum Heidelberg
69126 Heidelberg
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-MapsLungenklinik Hemer
58675 Hemer
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-MapsLungenkrebszentrum Uniklinik Köln / Solingen
Kerpener Straße 62
50937 Köln
DeutschlandNoch nicht rekrutierend» Google-MapsKliniiken der Stadt Köln gGmbH, Krankenhaus Köln-Mehrheim
51109 Köln
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» 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
90089-9173 Los Angeles
United StatesNoch nicht rekrutierend» Google-MapsUniversity of California, Irvine
92868 Orange
United StatesNoch nicht rekrutierend» Google-MapsStandford University
94304 Palo Alto
United StatesNoch nicht rekrutierend» Google-MapsUCSF Helen Diller Comprehensive
94158 San Francisco
United StatesNoch nicht rekrutierend» Google-MapsCedars Sinai Medical Center
90048 West Hollywood
United StatesNoch nicht rekrutierend» Google-MapsMayo Clinic
32224 Jacksonville
United StatesZurückgezogen» Google-MapsH. Lee Moffitt Cancer & Research Institute
33612 Tampa
United StatesNoch nicht rekrutierend» Google-MapsMassachusetts General Hospital
02114 Boston
United StatesNoch nicht rekrutierend» Google-MapsBoston University Medical Center
02118 Boston
United StatesRekrutierend» Google-MapsDana Farber Cancer Institute
02215 Boston
United StatesNoch nicht rekrutierend» Google-MapsBarbara Ann Karmanos Cancer Institute
48201 Detroit
United StatesRekrutierend» Google-MapsMayo Clinic
55905 Rochester
United StatesZurückgezogen» 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 StatesNoch nicht rekrutierend» Google-MapsVirginia Cancer Specialists
22031 Fairfax
United StatesRekrutierend» Google-MapsUniversity of Washington
98109 Seattle
United StatesNoch nicht rekrutierend» Google-MapsBeijing Cancer Hospital
100142 Beijing
ChinaNoch nicht rekrutierend» Google-MapsThe First Bethune Hospital of Jilin University
130021 Changchun
ChinaRekrutierend» Google-MapsHunan Cancer hospital
410013 Changsha
ChinaNoch nicht rekrutierend» Google-MapsWest China School of Medicine/West China Hospital, Sichuan University
610041 Chengdu
ChinaRekrutierend» Google-MapsChongqing Cancer hospital
400030 Chongqing
ChinaRekrutierend» Google-MapsThe Fifth Affiliated Hospital of Guangzhou Medical University
440112 Guangzhou
ChinaRekrutierend» Google-MapsZhejiang Cancer Hospital
310022 Hang Zhou
ChinaNoch nicht rekrutierend» Google-MapsCentral Hospital of Jinan
250013 Jinan
ChinaRekrutierend» Google-MapsThe First Affiliated Hospital of NanChang University
330006 Nanchang
ChinaNoch nicht rekrutierend» Google-MapsShanghai Chest Hospital
200030 Shanghai
ChinaRekrutierend» Google-MapsShengjing Hospital of China Medical University
110022 Shenyang
ChinaNoch nicht rekrutierend» Google-MapsTianjin Medical University Cancer Institute and Hospital
300000 Tianjin
ChinaNoch nicht rekrutierend» Google-MapsUnion Hospital Tongji Medical College of Huazhong University of Science and Technology
430022 Wuhan
ChinaNoch nicht rekrutierend» Google-MapsFirst Affiliated Hospital, Xi'an Jiaotong University
710061 Xi'an
ChinaRekrutierend» Google-MapsInstitut Bergonié
33000 Bordeaux
FranceRekrutierend» Google-MapsCentre Leon Bérard
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 Istituto Europeo di Oncologia
Milano
ItalyRekrutierend» Google-MapsIstituto Nazionale Tumori Fondazione G. Pascale
80131 Napoli
ItalyRekrutierend» Google-MapsOspedale S. Maria Delle Croci
48121 Ravenna
ItalyNoch nicht rekrutierend» Google-MapsNational Cancer Center Hospital
104-0045 Chuo-Ku
JapanRekrutierend» Google-MapsKansai Medical University Hospital
573-1191 Hirakata
JapanRekrutierend» Google-MapsNational Cancer Center Hospital East
277-8577 Kashiwa
JapanRekrutierend» Google-MapsKobe City Medical Center General Hospital
650-0047 Kobe-City,
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 Sunto-gun
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
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-MapsInst. Cat. Doncologia-H Duran I Reynals
08908 Hospitalet de Llobregat, Barcelona
SpainZurückgezogen» Google-MapsHosp. Gral. Univ. Gregorio Marañon
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
Studien-Informationen
Brief Summary: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 with Amivantamab (Phase 1b), to characterize the
safety and tolerability of lazertinib and Amivantamab combinations at the RP2CD in
participants with advanced NSCLC with documented advanced or metastatic EGFR mutation (Phase
1b expansion cohorts A, B and C) and to estimate the antitumor activity of lazertinib and
Amivantamab combinations at the RP2CD in participants with advanced NSCLC with documented
advanced or metastatic EGFR mutation (Phase 1b expansion cohorts A, B and C).
Ein-/Ausschlusskriterien
Inclusion Criteria:- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) with
previously epidermal growth factor receptor (EGFR) mutation (identified locally in a
Clinical Laboratory Improvement Amendments [CLIA]-certified laboratory [or
equivalent]) that is metastatic or unresectable, and have progressed after standard of
care front-line therapy, and exhausted available options with targeted therapy. A
participant who has refused all other currently available therapeutic options is
allowed to enroll. Phase 1b expansion Cohort A, B and C: For all expansion cohorts,
the EGFR mutation must have been previously histologically or cytologically
characterized, as performed by a CLIA-certified (US sites) or an accredited (outside
of US) local laboratory, with a copy of the mutation analysis being submitted during
screening. Expansion Cohort A: Participant must have advanced or metastatic
EGFR-mutated non-small cell lung cancer (NSCLC) that has progressed on prior treatment
with osimertinib in the first or second line, followed by progression on a
platinum-based chemotherapy regimen as the last line of therapy prior to study
enrollment. Prior use of first or second generation EGFR tyrosine kinase inhibitor
(TKI) is allowed if administered prior to osimertinib. Expansion Cohort B: Participant
must have previously treated, advanced or metastatic NSCLC with documented primary
EGFR Exon 20ins activating mutation. Participants should have been treated with
standard of care, platinum-based chemotherapy regimens, but may have treated with
approved EGFR TKI, investigational EGFR, or immunotherapy agents if refusing front
line platinum-based chemotherapy standard of care. Up to 3 lines of prior systemic
anti-cancer treatment are allowed. Expansion Cohort C: Participant must have advanced
or metastatic NSCLC characterized by an uncommon activating mutation Additional
uncommon EGFR mutations/alterations, beyond those listed above, may be considered for
enrollment after agreement with the medical monitor. Participants may be treatment
naïve or have been treated with one prior line of therapy which must be a first or
second generation TKI (that is gefitinib, erlotinib, afatinib) in the most recent line
of therapy. Prior chemotherapy is allowed if administered prior to EGFR TKI therapy,
or as the only systemic anti-cancer therapy prior to study enrollment. Up to 2 lines
of prior systemic anti-cancer treatment are allowed
- Evaluable disease
- Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
- Participants must meet the study protocol defined laboratory criteria without having a
history of red blood cell transfusion, platelet transfusion, or granulocyte-colony
stimulating factor support within 7 days prior to the date of the test
- A woman of childbearing potential: Must have a negative serum beta human chorionic
gonadotropin at screening; Must agree not to breast-feed during the study and for 6
months after the last dose of study intervention. (Enrollment is not allowed even if a
woman who is breast-feeding stops breast-feeding); Must agree not to donate eggs (ova,
oocytes) for the purposes of assisted reproduction during the study and for 6 months
after receiving the last dose of study intervention
Exclusion Criteria:
- Participant has an uncontrolled illness, including but not limited uncontrolled
diabetes, ongoing or active infection (includes infection requiring treatment with
antimicrobial therapy [participants will be required to complete antibiotics week
prior to study treatment] or diagnosed or suspected viral infection); active bleeding
diathesis; Impaired oxygenation requiring continuous oxygen supplementation;
Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to
swallow the formulated product, or previous significant bowel resection that would
preclude adequate absorption of study treatment; or psychiatric illness or any other
circumstances including (social circumstances) that would limit compliance with study
requirements. Any ophthalmologic condition that is either clinically unstable or
requires treatment
- Prior treatment with antiPD-1 or anti Programmed death-ligand 1 (PD-L1) antibody
within 6 weeks of planned first dose of study intervention
- Untreated brain or other central nervous system (CNS) metastases whether symptomatic
or asymptomatic. Participants who have completed definitive therapy, are not on
steroids, and have a stable clinical status for at least 2 weeks prior to study
treatment may be eligible for Phase 1b expansion cohorts. If brain metastases are
diagnosed on Screening imaging, the participant may be enrolled, or rescreened for
eligibility, after definitive treatment if above criteria are met
- Any Toxicities from prior anticancer therapy must have resolved to common terminology
criteria for adverse events (CTCAE) Grade 1 or baseline level (except for alopecia
[any grade], Grade <=2 peripheral neuropathy, and Grade <=2 hypothyroidism stable on
hormone replacement therapy)
- Allergies, hypersensitivity, or intolerance to lazertinib (both Phase 1 and Phase 1b)
and Amivantamab (Phase 1b only) or their excipients
Studien-Rationale
Primary outcome: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) (Time Frame - Up to 2 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) (Time Frame - Up to 2 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.
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 1.8 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 1.8 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 1.8 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 1.8 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 1.8 years (end of treatment)):
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 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 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 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 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.
Studien-Arme
- 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 (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 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 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 and Amivantamab, every 7 days for the first 28 days cycle and every 2 weeks thereafter.
Geprüfte Regime
- Lazertinib (JNJ-73841937):
Lazertinib will be administered orally. - Amivantamab (JNJ-61186372):
Amivantamab will be administered as an intravenous infusion.
Quelle: ClinicalTrials.gov