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Clinical Trials List

Protocol Number73841937NSC1001
NCT Number(ClinicalTrials.gov Identfier)NCT04077463
Active

2020-09-01 - 2027-05-01

Phase I

Recruiting5

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

An Open-label Phase 1/1b Study to Evaluate the Safety and Pharmacokinetics of JNJ- 73841937 (Lazertinib), a Third Generation EGFR-TKI, as Monotherapy or in Combinations With JNJ-61186372, a Human Bispecific EGFR and cMet Antibody in Participants 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 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 Chien-Chung Lin Division of Thoracic Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

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

Principal Investigator Jen-Yu Hung Division of Thoracic Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator
Kaohsiung Municipal Ta-Tung Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

NSCLC

Objectives

Primary Objectives  To confirm the tolerability of RP2D of lazertinib (Phase 1)  To determine the tolerability and identify the recommended Phase 2 combination dose (RP2CD) of lazertinib when combined with JNJ-61186372 (Phase 1b combination cohorts)  To characterize the safety and tolerability of lazertinib and JNJ-61186372 combinations at the RP2CD in participants with advanced NSCLC with documented EGFR mutation (Phase 1b expansion cohorts)  To estimate the antitumor activity of lazertinib and JNJ-61186372 combinations at the RP2CD in participants with advanced NSCLC with documented EGFR mutation (Phase 1b expansion cohorts) Secondary objectives  To characterize the pharmacokinetics (PK) of lazertinib and PK and immunogenicity of JNJ-61186372 in combination with lazertinib  To assess additional measures of clinical benefit with lazertinib and JNJ-61186372 combination at RP2CD in the Phase 1b expansion cohorts.

Test Drug

JNJ-61186372JNJ-73841937(lazertinib)

Active Ingredient

JNJ-61186372
JNJ-73841937(lazertinib)

Dosage Form

vial
tablet

Dosage

50 mg/ml
80 mg

Endpoints

Primary Outcome Measures :
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.

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.

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.

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.

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.

Number of Participants with AEs as a Measure of Safety and Tolerability (Phase 1b combination LACP) [ Time Frame: Up to 2 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.

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 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).

Inclution Criteria

Main inclusion criteria:
1. Participant must be ≥18 years of age and satisfy the legal age of consent in the jurisdiction in which the study is being conducted.
2. Phase 1 and Phase 1b combination cohorts: Histologically or cytologically confirmed NSCLC with previously identified 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: Histologically or cytologically confirmed metastatic or unresectable EGFR-mutated NSCLC (EGFR exon19 deletion or L858R) that has progressed on prior treatment with both osimertinib and platinum-doublet chemotherapy for metastatic disease. Note that the use of platinum-doublet chemotherapy in adjuvant or neo-adjuvant setting is allowed, if the last dose was administered less than 12 months prior to planned first dose of study drug.
3. Phase 1 and Phase 1b combination cohorts: Evaluable disease. Phase 1b expansion cohorts: Measurable disease according to RECIST v1.1.
4. ECOG performance status grade of 0 or 1
5. Organ and bone marrow function as follows:

Participants must meet the above 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.
6. 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 [a woman should still be considered of childbearing potential if amenorrhea is due to a medical reason, eg, drug-induced amenorrhea]); 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 not planning to become pregnant and practicing effective method(s) of birth control as described below:
1) Practicing true abstinence (when this is in line with the preferred and usual lifestyle of the participant), 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 intervention. Periodic abstinence (calendar, symptothermal, postovulation methods) is not considered an acceptable contraceptive method.
or
2) Have a sole partner who is vasectomized. He must still use a condom.
or
3) Practicing two contraceptive methods and one must be user-independent
method. Examples of highly effective contraceptives include:
-User-independent methods: intrauterine device or intrauterine contraceptive system.
-User-dependent methods: oral combined (estrogen- and progestogen-containing) hormonal contraception.
Participants must agree to continue contraception throughout the study and continuing through 6 months after the last dose of study intervention.
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.
7. A woman of childbearing potential
-Must have a negative serum or urine β-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.
8. A man who is sexually active with a woman of childbearing potential must agree to continue contraception throughout the study including up to 6 months after the last dose of study intervention. He must use a condom and his partner must also be practicing a highly effective method of contraception (ie, established use of oral combined hormonal methods of contraception; placement of an intrauterine device or intrauterine system).
If the participant is vasectomized, he must still use a condom, but his female partner is not required to use contraception.
The participant must also not to donate sperm during the study and for 6 months after receiving the last dose of study intervention.
9. Willing and able to adhere to the prohibitions and restrictions specified in this protocol.
10. Each participant 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.

Exclusion Criteria

Main exclusion criteria:
1. Uncontrolled intercurrent illness, including but not limited to poorly controlled hypertension or diabetes, ongoing or active infection (ie, has not discontinued all antibiotics for at least one week prior to first dose of study intervention), or psychiatric illness/social situation that would limit compliance with study requirements. Participants with medical conditions requiring continuous oxygen therapy are excluded.
2. Prior treatment with antiPD-1 or antiPD-L1 antibody within 6 weeks of planned first dose of study intervention.
3. Prior chemotherapy, targeted cancer therapy, immunotherapy (refer to Exclusion Criterion #2 for antiPD-1 or antiPD-L1 therapy), or treatment with an investigational anticancer agent within 2 weeks or 4 half-lives whichever is longer, before the first administration of study intervention(s). For agents with long half-lives, the maximum required time since last dose is 4 weeks. Note: Localized radiotherapy for palliative purposes must be completed at least 7 days prior to the first administration of study intervention(s).
4. Symptomatic brain metastases or brain metastases requiring treatment. Exception: participants with asymptomatic, untreated brain metastases, each less than 1 cm in diameter, may be eligible for Phase 1b expansion cohorts.
5. 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 therapy).
6. History of clinically significant cardiovascular disease including, but not limited to:
 Diagnosis of deep vein thrombosis or pulmonary embolism within 4 weeks prior to the first dose of study intervention. Clinically nonsignificant thrombosis, such as nonobstructive catheter-associated clots, are not exclusionary.
 Any of the following within 24 weeks prior to the first dose of study intervention: myocardial infarction, unstable angina, stroke, transient ischemic attack, coronary/peripheral artery bypass graft, or any acute coronary syndrome.
 Prolonged corrected QT interval by Fredericia (QTcF) interval >480 msec or clinically significant cardiac arrhythmia or electrophysiologic disease (eg, placement of implantable cardioverter defibrillator or atrial fibrillation with uncontrolled rate). Note: Participants with cardiac pacemakers who are clinically stable are eligible.
 Uncontrolled (persistent) hypertension: systolic blood pressure >180 mm Hg; diastolic blood pressure >100 mm Hg
 Congestive heart failure defined as New York Heart Association Class III-IV or hospitalization for congestive heart failure (any New York Heart Association Class) within 6 months prior to the first dose of study intervention.
 Pericarditis/clinically significant pericardial effusion.
 Myocarditis.
 Phase 1b expansion only: Baseline LVEF below the lower limit of normal (LLN), as assessed by screening echocardiogram or multigated acquisition (MUGA) scan.
7. Taken any disallowed therapies, Concomitant Therapy before the planned first dose of study intervention.
8. Allergies, hypersensitivity, or intolerance to lazertinib (both Phase 1 and Phase 1b) or JNJ-61186372 (Phase 1b only) or their excipients (refer to IBs).
9. Received an investigational intervention (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 intervention.
10. Had, or is scheduled to 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 participant has adequately recovered from the procedure prior to the first dose of study intervention 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 participant safety if wound healing capacity would be severely reduced during administration of the study intervention.
d. Expected major surgery while the investigational agent is being administered or within 6 months after the last dose of study intervention.
11. Investigative site personnel directly affiliated with this study.
12. Seropositive hepatitis B or hepatitis C.
Defined by a positive test for hepatitis B surface antigen (HBsAg) or antibody to HBsAg and antibody to hepatitis B core antigens (anti-HBs antibody and anti-HBc antibody, respectively), or hepatitis C antibody. Participants who test positive for anti-HBs antibody and/or anti-HBc antibody must have hepatitis B deoxyribonucleic acid (DNA) by polymerase chain reaction performed and confirmed as negative prior to study intervention administration. Participant who test positive for hepatitis C antibody are eligible if previously treated and achieved a sustained viral response, defined as a negative viral load for hepatitis C after completion of the treatment for hepatitis.
13. Human immunodeficiency virus antibody positive, or tests positive for human immunodeficiency virus at screening.
14. 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 participant to receive or tolerate the planned treatment at the study site, to understand informed consent or that in the opinion of the investigator would contraindicate the participant’s participation in the study or confound the results of the study.
15. 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.
16. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
17. Phase 1b expansion cohorts only: 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).
18. Has leptomeningeal disease.

The Estimated Number of Participants

  • Taiwan

    36 participants

  • Global

    685 participants

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