問卷
Log In
繁中 EN
TPIDB
TPIDB Outstanding PI
TPIDB > Search Result > Clinical Trials List

Clinical Trials List

Protocol Number61186372EDI1001
NCT Number(ClinicalTrials.gov Identfier)NCT02609776
Completed

2018-12-30 - 2024-12-31

Phase I

Not yet recruiting1

Recruiting6

ICD-10C34

Malignant neoplasm of bronchus and lung

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-61186372, a Human Bispecific EGFR and cMet Antibody, in Subjects With Advanced Non-Small Cell Lung Cancer

  • Trial Applicant

    Johnson & Johnson

  • Sponsor

    Janssen Research & Development, LLC

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Te-Chun Hsia Division of Thoracic Medicine
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yung-Hung Luo Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

1 Recruiting

Audit

None

Principal Investigator TSUNG -YING YANG Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Te-Chun Hsia 未分科
China Medical University Hospital-Taipei

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

2 Recruiting

Audit

None

Principal Investigator James Chih-Hsin Yang Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Principal Investigator Gee-chen Chang Division of Thoracic Medicine
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 魏裕峰 Division of Thoracic Medicine
E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

Advanced Non-Small Cell Lung Cancer

Objectives

The purpose of study is to evaluate the safety, pharmacokinetics, and preliminary efficacy of Amivantamab as a monotherapy and in combination with lazertinib, and to determine the recommended Phase 2 dose (RP2D) (monotherapy), recommended Phase 2 combination dose (RP2CD) (combination therapy), and to determine recommended Phase 2 Dose (RP2q3W) with combination chemotherapy (Amivantamab in combination with standard of care carboplatin and pemetrexed) in 21 day treatment cycle for participants with advanced non-small cell lung cancer (NSCLC).

Test Drug

JNJ-61186372、Lazertinib (JNJ-73841937)

Active Ingredient

JNJ-61186372
Lazertinib (JNJ-73841937)

Dosage Form

vial
vial
tablet

Dosage

150mg/vial (50mg/mL)
350mg/vial (50mg/mL)
80 mg/tablet

Endpoints

Primary Outcome Measures :
Part 1: Number of Participants With Dose Limiting Toxicity (DLT) [ Time Frame: Up to Day 28 ]
The Dose Limiting Toxicity (DLT) is based on drug related adverse events and includes unacceptable hematologic toxicity, non-hematologic toxicity of Grade 3 or higher, or elevations in hepatic enzymes suggestive of drug-induced liver injury.

Part 2: Number of Participants With Adverse Events (AEs) and Serious AEs [ Time Frame: Screening up to follow-up (30 [+7] days after the last dose) ]
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Part 2: Overall Response Rate (ORR) [ Time Frame: Up to End of Treatment Follow (EOT) Up Period (30 [+7] days after the last dose) ]
Overall response rate (ORR) is defined as the percentage of participants who achieve either a CR or PR as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1). CR: disappearance of all target lesions and non-target lesions. All lymph nodes must be non-pathological in size (< 10 mm short axis) and normalisation of tumour marker levels; PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters and Persistence of one or more non-target lesion(s) and/or maintenance of tumour marker level above the normal limits.

Part 2: Duration of Response (DOR) [ Time Frame: Up to EOT Follow Up Period (30 [+7] days after the last dose) ]
DOR will be calculated as time from initial response of CR (disappearance of all target lesions and non-target lesions. All lymph nodes must be non-pathological in size ([<] 10 [mm] short axis) and normalisation of tumour marker levels) or PR (at least a 30 [%] decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters and persistence of one or more non-target lesion(s) and/or maintenance of tumour marker level above the normal limits or durable stable disease (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study and persistence of one or more non-target lesion(s) and/or maintenance of tumour marker level above the normal limits) to progressive disease (PD) or death due to underlying disease, whichever comes first, only for participants who achieve CR or PR.

Part 2: Percentage of Participants With Clinical Benefit [ Time Frame: Up to EOT Follow Up Period (30 [+7] days after the last dose) ]
Clinical benefit rate is defined as the percentage of participants achieving complete response (CR): disappearance of all target lesions and non-target lesions. All lymph nodes must be non-pathological in size (less than [<] 10 millimeter [mm] short axis) and normalisation of tumour marker levels or partial response (PR): at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters and persistence of one or more non-target lesion(s) and/or maintenance of tumour marker level above the normal limits or durable stable disease (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study and persistence of one or more non-target lesion(s) and/or maintenance of tumour marker level above the normal limits.

Trough Serum Concentration (Ctrough) of Amivantamab [ Time Frame: Up to EOT (30 days after last dose) ]
Ctrough is the observed serum concentration immediately prior to the next administration.

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Amivantamab [ Time Frame: Up to EOT (30 days after last dose) ]
The AUCtau is the area under the serum concentration-time curve during a dose interval time period (tau)


Secondary Outcome Measures :
Maximum Serum Concentration (Cmax) of Amivantamab [ Time Frame: Cycle 1 Day 1: predose through end of infusion (EOT) or Follow Up (approximately 16 months) (each cycle is of 28 days) ]
The Cmax is the maximum observed serum concentration of Amivantamab.

Time to Reach Maximum Observed Serum Concentration (Tmax) of Amivantamab [ Time Frame: Cycle 1 Day 1: predose through EOT or Follow Up (approximately 16 months) ]
The Tmax is defined as time to reach maximum observed serum concentration of Amivantamab.

Area Under the Serum Concentration-Time Curve From t1 to t2 Time (AUC[t1-t2]) of Amivantamab [ Time Frame: Cycle 1 Day 1: predose through EOT or Follow Up (approximately 16 months) ]
The AUC(t1-t2) is the area under the serum Amivantamab concentration-time curve from time t1 to t2.

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Amivantamab [ Time Frame: Cycle 1 Day 1: predose through EOT or Follow Up (approximately 16 months) ]
The AUCtau is the area under the serum concentration-time curve during a dose interval time period (tau)

Trough Serum Concentration (Ctrough) of Amivantamab [ Time Frame: Cycle 1 Day 1: predose through EOT or Follow Up (approximately 16 months) ]
The Ctrough is the observed serum concentration immediately prior to the next administration.

Maximum Serum Concentration (Cmax) of Lzertinib [ Time Frame: Cycle 1 Day 1: predose through EOT (30 [+7] days after last dose [Cycle 4 Day 15]) (each cycle is of 28 days) ]
Cmax is the maximum observed serum concentration of lazertinib.

Time to Reach Maximum Observed Serum Concentration (Tmax) of Lazertinib [ Time Frame: Cycle 1 Day 1: predose through EOT (30 [+7] days after last dose [Cycle 4 Day 15]) (each cycle is of 28 days) ]
Tmax is defined as time to reach maximum observed serum concentration of lazertinib.

Trough Serum Concentration (Ctrough) of Lazertinib [ Time Frame: Cycle 1 Day 1: predose through EOT (30 [+7] days after last dose [Cycle 4 Day 15]) (each cycle is of 28 days) ]
Ctrough is the observed serum concentration immediately prior to the next administration.

Accumulation ratio (R) of Amivantamab [ Time Frame: Cycle 1 Day 1: predose through EOT or Follow Up (approximately 16 months) ]
The R is the accumulation ratio calculated as Cmax or AUC after multiple doses divided by Cmax or AUC after the first dose, respectively.

Number of Participants With Anti-Drug Antibodies (ADA) [ Time Frame: Cycle 1 Day 1: predose through EOT or Follow Up (approximately 16 months) ]
Serum levels of antibodies to Amivantamab for evaluation of potential immunogenicity.

Progression-Free Survival (PFS) [ Time Frame: Up to End of Treatment Follow Up Period (30 [+7] days after the last dose) ]
PFS is defined as the time from first infusion of study drug to PD or death due to any cause.

Time to Treatment Failure (TTF) [ Time Frame: Up to End of Treatment Follow Up Period (30 [+7] days after the last dose) ]
TTF is defined as the time from the first infusion of the study drug 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 RECIST v1.1 defined disease progression.

Overall Survival (OS) [ Time Frame: Up to End of Treatment Follow Up Period (30 [+7] days after the last dose) ]
OS is defined as the time from first infusion of study drug to death due to any cause.

Inclution Criteria

Inclusion Criteria
Each potential subject must satisfy all of the following criteria to be enrolled in the study.
1. Subject must be ≥ 18 years of age and satisfy the legal age of consent in the jurisdiction in
which the study is being conducted.
2. Criterion modified per Amendment 4
2.4 Subject must have histologically or cytologically confirmed NSCLC that is metastatic
or unresectable. Subjects must have either progressed after receiving prior therapy for
metastatic disease, be ineligible for, or have refused all other currently available
therapeutic options.
3. Criterion modified per Amendment 5
3.5 For Part 2 only: Subjects must also have disease with a previously diagnosed activating
EGFR mutation (includes both inhibitor sensitive primary mutations such as Exon 19
deletion and L858R [Cohort C], as well as marketed TKI-resistant mutations such as
Exon 20 insertion [Cohort C and D]). Documentation of EGFR mutation eligibility by
CLIA-certified laboratory (or equivalent) testing is required.
4. For Part 1: Subject must have evaluable disease.
For Part 2: Subject must have measurable disease according to RECIST v1.1.
5. Criterion modified per Amendment 5
5.5 For Part 2:
Cohort A and B: Subject’s disease must have most recently progressed following treatment
with a marketed EGFR inhibitor. Exception: In subjects diagnosed with mutations
associated with de novo EGFR inhibitor resistance (eg, exon 20 insertions), only
previous treatment with combination platinum-based chemotherapy is required.
Cohort C: Subjects must have documented EGFR or cMET alterations mediating
resistance to previous treatment with a third generation TKI (eg, osimertinib), or in the
case of primary Exon 20ins disease, previous treatment with a TKI with known
activity against Exon 20ins disease (eg poziotinib). Examples of eligible EGFR and
cMET alterations are listed in Attachment 7, which must be demonstrated by previous
characterization, using local lab testing of equivalent tumor tissue prior to screening,
until appropriately validated NGS of ctDNA or tumor tissue for central testing is
available. Once available, all subjects will be centrally assessed for eligibility based on
EGFR and cMET characterization of tumor sample obtained during the Screening
period, or with equivalent tumor tissue obtained prior to the Screening Period, but
following treatment with most recent systemic anti-cancer therapy.
Cohort D: Subjects must have been previously diagnosed with an EGFR Exon 20 insertion.
6. Subject must have ECOG performance status 0 or 1 (Attachment 1).
7. Criterion modified per Amendment 4
7.4 Subject must have organ and bone marrow function as follows:
Subjects must meet laboratory criteria above without having history of red blood cell
transfusion, platelet transfusion or G-CSF support within 7 days prior to the date of the
test.
8. Before enrollment, a woman must be either:
a. Not of childbearing potential: premenarchal; postmenopausal (>45 years of age with
amenorrhea for at least 12 months); permanently sterilized (eg, bilateral tubal
occlusion [which includes tubal ligation procedures as consistent with local
regulations], hysterectomy, bilateral salpingectomy, bilateral oophorectomy); or
otherwise be incapable of pregnancy,
b. Of childbearing potential and practicing effective method(s) of birth control consistent
with local regulations regarding the use of birth control methods for subjects
participating in clinical studies, as described below:
1) Practicing true abstinence (when this is in line with the preferred and usual
lifestyle of the subject), which is defined as refraining from heterosexual
intercourse during the entire period of the study, including up to 6 months after
the last dose of study drug is given. Periodic abstinence (calendar,
symptothermal, post-ovulation methods) is not considered an acceptable
contraceptive method.
or
2) Have a sole partner who is vasectomized
or
3) Practicing 2 methods of contraception, including one highly effective method (ie,
established use of oral, injected or implanted hormonal methods of contraception;
placement of an intrauterine device [IUD] or intrauterine system [IUS], AND, a
second method, (eg, condom with spermicidal foam/gel/film/cream/suppository or occlusive cap [diaphragm or cervical/vault caps] with spermicidal
foam/gel/film/cream/suppository)
Subjects must agree to continue contraception throughout the study and continuing
through 6 months after the last dose of study drug.
Note: If the childbearing potential changes after start of the study (eg, woman who is
not heterosexually active becomes active, premenarchal woman experiences
menarche) the woman must begin a highly effective method of birth control, as
described above.
9. A woman of childbearing potential must have a negative serum (-human chorionic
gonadotropin [-hCG]) at screening.
10. A woman 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 drug.
11. A man who is sexually active with a woman of childbearing potential must agree to use a
condom with spermicidal foam/gel/film/cream/suppository and his partner must also be
practicing a highly effective method of contraception (ie, established use of oral, injected
or implanted hormonal methods of contraception; placement of an intrauterine device
[IUD] or intrauterine system [IUS]).
If the subject is vasectomized, he must still use a condom (with or without spermicide), but
his female partner is not required to use contraception.
The subject must also not donate sperm during the study and for 6 months after receiving
the last dose of study drug.
12. Subject must be willing and able to adhere to the prohibitions and restrictions specified in
this protocol.
13. Criterion modified per Amendment 5
13.5 Each subject must sign an informed consent form (ICF) indicating that he or she
understands the purpose of and procedures required for the study is willing to
participate in the study, including the requirement to provide information during the
Follow-up period.
14. Criterion modified per Amendment 5
14.5 Subjects eligible for Part 2 must agree to the pre-treatment tumor biopsy (or
submission of equivalent archival material) and a tumor biopsy at the time of disease
progression, as well as corresponding blood samples for ctDNA analysis. For subjects
in Cohort C, equivalent pre-treatment tumor tissue must have been collected
following treatment with the most recent prior systemic anti-cancer treatment.

Exclusion Criteria

Exclusion Criteria
Any potential subject who meets any of the following criteria will be excluded from participating
in the study.
1. Subject has uncontrolled inter-current illness, including but not limited to poorly controlled
hypertension or diabetes, ongoing or active infection, or psychiatric illness/social situation
that would limit compliance with study requirements.
2. Criterion modified per Amendment 5
2.5 Subject has had prior chemotherapy, targeted cancer therapy, immunotherapy, or
treatment with an investigational anticancer agent within 2 weeks or 4 half-lives
whichever is longer, before the first administration of JNJ-61186372. For agents with
long half-lives, the maximum required time since last dose is 4 weeks. Toxicities from
previous anticancer therapies should have resolved to baseline levels or to Grade 1 or
less, (except for alopecia [any grade], Grade ≤2 peripheral neuropathy, and Grade <2
hypothyroidism stable on hormone replacement).
For Part 2 only:
Cohorts A and B: Prior treatment with chemotherapy for metastatic disease is not
allowed unless the tumor mutation carries de-novo resistance to EGFR TKI (eg,
exon-20 insertions).
Cohort C: Prior treatment with more than 2 lines of cytotoxic chemotherapy for
metastatic disease (maintenance therapy is not included).
Cohort D: Previous treatment with an EGFR TKI with activity against EGFR Exon 20
insertions (such as poziotinib).
Note: Localized, radiotherapy for palliative purposes must be completed at least 7 days
prior to treatment with JNJ-61186372. See Section 7.6 for information regarding irradiated
target lesions.
3. Criterion modified per Amendment 4
3.4 Subjects with untreated brain metastases. Patients with treated metastases that are
clinically stable and asymptomatic for at least 2 weeks and who are off or receiving
low-dose corticosteroid treatment (≤10 mg prednisone or equivalent) for at least 2
weeks prior to study treatment are eligible.
4. Criterion modified per Amendment 3
4.3 Subject has a history of malignancy other than the disease under study within 3 years
before screening (exceptions are squamous and basal cell carcinomas of the skin and
carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator,
with concurrence with the sponsor's medical monitor, is considered cured, or with
minimal risk of recurrence within a year from screening).
5. Criterion modified per Amendment 5
5.5 Subject has a history of clinically significant cardiovascular disease including, but not
limited to:
 Diagnosis of deep vein thrombosis or pulmonary embolism within 1 month prior to the
first dose of study drug, or any of the following within 6 months prior to the first dose
of study drug: myocardial infarction, unstable angina, stroke, transient ischemic attack,
coronary/peripheral artery bypass graft, or any acute coronary syndrome. Clinically
non-significant thrombosis, such as non-obstructive catheter-associated clots, are not
exclusionary.
 Prolonged QTcF interval >480 msec or clinically significant cardiac arrhythmia or
electrophysiologic disease (eg, placement of implantable cardioverter defibrillator or
atrial fibrillation with uncontrolled rate).
 Uncontrolled (persistent) hypertension: systolic blood pressure >180 mmHg; diastolic
blood pressure >100 mmHg
 Congestive heart failure defined as New York Heart Association (NYHA) class III-IV
(Attachment 2) or Hospitalization for CHF (any NYHA class) within 6 months of
study Day 1
 Pericarditis/clinically significant pericardial effusion
 Myocarditis
6. Subject has leptomeningeal disease.
7. Subject has known allergies, hypersensitivity, or intolerance to JNJ-61186372 or its
excipients (refer to Investigator's Brochure).
8
8. Criterion modified per Amendment 5
8.5 Subject has received an investigational drug (including investigational vaccines, but not
including anticancer therapy [refer to Exclusion Criterion #2]) or used an invasive
investigational medical device within 6 weeks before the planned first dose of study
drug.
9. Subject is a woman who is pregnant, or breast-feeding, or planning to become pregnant
while enrolled in this study or within 6 months after the last dose of study drug.
10. Subject is a man who plans to father a child while enrolled in this study or within 6 months
after the last dose of study drug.
11. Criterion modified per Amendment 4
11.4 Subject has, or will have, any of the following:
a. An invasive operative procedure with entry into a body cavity, within 4 weeks or
without complete recovery before Cycle 1 Day 1. Thoracentesis, if needed, and
percutaneous biopsy for baseline tumor tissue sample may be done less than 4 weeks
prior to Cycle 1 Day 1, as long as the subject has adequately recovered from the
procedure prior to the first dose of study drug in the clinical judgement of the
investigator;
b. Significant traumatic injury within 3 weeks before the start of Cycle 1 Day 1 (all
wounds must be fully healed prior to Day 1);
c. Any medical condition that requires intact wound healing capacity and is expected to
endanger subject safety if wound healing capacity would be severely reduced during
administration of the investigational agent;
d. Expected major surgery while the investigational agent is being administered or within
6 months after the last dose of study drug.
12. Subject has any condition for which, in the opinion of the investigator, participation would
not be in the best interest of the subject (eg, compromise the well-being) or that could
prevent, limit, or confound the protocol-specified assessments.
13. Any investigative site personnel directly affiliated with this study.
14. Criterion modified per Amendment 5
14.5 Subject has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody
(anti-HCV) positive, or other clinically active infectious liver disease, or tests positive
for HBsAg or anti-HCV at Screening.
Note: Subjects with a history of hepatitis C, who have completed antiviral treatment
and have subsequently documented absence of serum HCV RNA at Screening are
allowed to participate.
15. Subject has a history of human immunodeficiency virus (HIV) antibody positive, or tests
positive for HIV at Screening.
16. Subject has any serious underlying medical or psychiatric condition (eg, alcohol or drug
abuse), dementia or altered mental status or any issue that would impair the ability of the
subject to receive or tolerate the planned treatment at the investigational site, to understand
informed consent or that in the opinion of the investigator would contraindicate the
subject’s participation in the study or confound the results of the study.
17. Medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation
pneumonitis requiring treatment with prolonged steroids or other immune suppressive
agents within the last 2 years.

The Estimated Number of Participants

  • Taiwan

    35 participants

  • Global

    780 participants

聯絡我們

台灣臨床試驗主持人資料庫 TPIDB

All Contents Copyright 2020 台灣臨床試驗主持人資料庫TPIDB