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Clinical Trials List

Protocol Number73841937NSC3003
NCT Number(ClinicalTrials.gov Identfier)NCT04487080
Active

2020-09-01 - 2028-12-31

Phase III

Not yet recruiting7

Recruiting1

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

A Phase 3, Randomized Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib Versus Lazertinib as First-Line Treatment in Patients with EGFR-Mutated Locally Advanced or Metastatic 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 Not yet 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

Principal Investigator CHIN-CHOU WANG Division of Thoracic Medicine
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator kang-Yun LEE Division of Thoracic Medicine
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet 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 Not yet 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 Not yet 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 Te-Chun Hsia Division of Thoracic Medicine
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

NSCLC

Objectives

Third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) such as osimertinib are becoming standard of care as first line therapy for non-small cell lung cancer (NSCLC) harboring EGFR Exon 19del or L858R mutations. While osimertinib represents a significant advance over earlier EGFR TKIs, almost all patients eventually relapse. There is an unmet need to improve first line therapy to extend progression free survival (PFS) beyond the median of 19 months seen with osimertinib. Early data suggest that secondary EGFR mutations such as C797S and mesenchymal-epithelial transition (MET) activation are among the most frequent mechanisms of resistance in this setting

Test Drug

JNJ-61186372 (Amivantamab) / JNJ-73841937 (Lazertinib)

Active Ingredient

JNJ-61186372 (Amivantamab)
JNJ-73841937 (Lazertinib)

Dosage Form

Vial
tablet

Dosage

350 mg
80 mg

Endpoints

Primary：
 PFS according to RECIST v1.1 by blinded independent central review

Key Secondary：
To further assess the clinical benefit achieved using the amivantamab and lazertinib combination
compared with osimertinib in participants with EGFR mutation positive, locally advanced or
metastatic NSCLC.
 Overall survival
 Objective response rate
 Duration of response
 PFS after first subsequent therapy (PFS2)
 Time to symptomatic progression
 Intracranial PFS

Inclution Criteria

1. Participant must be ≥18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place).
2. Participant must have histologically or cytologically confirmed, locally advanced or metastatic NSCLC not amenable to curative therapy.
3. Participant must have a tumor that was previously determined to have Exon 19del or Exon 21 L858R substitution, as detected by an FDA-approved or other validated test in a CLIA certified laboratory (sites in the US) or an accredited local laboratory (sites
outside of the US) in accordance with site standard of care. The biopsy must have been obtained at or after the diagnosis of advanced disease. (Note: A copy of the test report documenting the EGFR mutation must be included in the participant records and must also be submitted to the sponsor.)
4. Unstained tumor tissue (in a quantity sufficient to allow for central analysis of EGFR mutation status, see Laboratory Manual) and blood (for ctDNA, digital droplet polymerase chain reaction [ddPCR], and pharmacogenomic analysis), both collected at
or after the diagnosis of locally advanced or metastatic NSCLC, must be provided
5. Any toxicities from prior anticancer therapy must have resolved to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or baseline level.
6. Participant must have at least 1 measurable lesion, according to RECIST v1.1 that has not been previously irradiated. Measurable lesions should not have been biopsied during screening, but if only 1 non-irradiated measurable lesion exists, it may undergo a diagnostic biopsy and be acceptable as a target lesion, provided the baseline tumor assessment scans are performed at least 14 days after the biopsy.
7. Participant must have adequate organ and bone marrow function as follows, without history of red blood cell transfusion, platelet transfusion, or granulocyte colony-stimulating factor (G-CSF) within 7 days prior to the date of the test.
 Hemoglobin ≥10 g/dL
 Absolute neutrophil count ≥1.5
 109 /L, without any prior use of G-CSF
 Platelets ≥75
 109/L
 Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3
 upper limit of normal (ULN)
 Total bilirubin ≤1.5  ULN (participants with Gilbert’s syndrome can enroll if conjugated bilirubin is within normal limits)
 Serum creatinine <1.5  ULN (or if available, creatinine clearance >45 mL/min/1.73 m2 as measured or calculated)
8. Participant must have Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
9. Participant must sign an ICF (or their legally acceptable representative must sign) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.
10. A woman of childbearing potential must have a negative serum or urine pregnancy test at screening and within 72 hours of the first dose of study treatment.
11. A woman must be (as defined in definition) either of the following:
a. Not of childbearing potential
b. Of childbearing potential and
 practicing true abstinence during the entire period of the study, including up to 6 months after the last dose of study treatment is given;
 have a sole partner who is vasectomized;
 or practicing 2 highly effective methods of contraception, including 1 user independent method and a second method (examples of highly effective methods of contraception are located in definition).
Participant must agree to continue contraception throughout the study and through 6 months after the last dose of study treatment.
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 2 highly effective methods of birth control, as described above
12. 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 treatment.
13. A man must wear a condom when engaging in any activity that allows for passage of ejaculate to another person during the study and for 6 months after receiving the last dose of study treatment. 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 hormone-releasing system [IUS]).
If the participant is vasectomized, he must still use a condom (with or without spermicide) for prevention of passage of exposure through ejaculation, but his female partner is not required to use contraception.
14. A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 6 months after receiving the last dose of study treatment.

Exclusion Criteria

1. Participant has received any prior systemic treatment for locally advanced or metastatic disease (adjuvant or neoadjuvant therapy is allowed, if administered more than 12 months prior to the development of locally advanced or metastatic disease).
2. Participant has symptomatic brain metastases. A participant with asymptomatic or previously treated and stable brain metastases may participate in this study. Participants who have received definitive radiation or surgical treatment for
symptomatic or unstable brain metastases and have been clinically stable and asymptomatic for at least 2 weeks before Screening are eligible, provided they have been either off corticosteroid treatment or are receiving low-dose corticosteroid
treatment (≤10 mg/day prednisone or equivalent) for at least 2 weeks prior to randomization.
3. Participant has an active or past medical history of leptomeningeal disease.
4. Participant has spinal cord compression that has not been definitively treated with surgery or radiation or requires steroid treatment within 2 weeks prior to randomization.
5. Participant has uncontrolled tumor-related pain (symptomatic lesions amenable to palliative radiotherapy [eg, bone metastases or metastases causing nerve impingement] should be treated prior to Screening).
6. Participant has an active or past medical history of ILD/pneumonitis, including drug-induced or radiation ILD/pneumonitis.
7. Participant has an uncontrolled illness, including but not limited to:
 Uncontrolled diabetes
 Ongoing or active infection (includes infection requiring treatment with antimicrobial therapy [participants will be required to complete antibiotics 1 week prior to starting 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
 Psychiatric illness, social situation, or any other circumstances that would limit compliance with study requirements
 Any ophthalmologic condition that is either clinically unstable or requires treatment
8. Participant has an active malignancy other than the disease being treated under study.
The only allowed exceptions are:
a. Non-muscle invasive bladder cancer (NMIBC) treated within the last 24 months that is considered completely cured.
b. Skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured.
c. Non-invasive cervical cancer treated within the last 24 months that is considered completely cured.
d. Localized prostate cancer (N0M0):
 with a Gleason score of 6, treated within the last 24 months or untreated and under surveillance,
 with a Gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence,
 or history of localized prostate cancer and receiving androgen deprivation therapy and considered to have a very low risk of recurrence.
e. Breast cancer:
 adequately treated lobular carcinoma in situ or ductal carcinoma in situ,
 or history of localized breast cancer and receiving antihormonal agents and considered to have a very low risk of recurrence.
f. Malignancy that, with consultation of Medical Monitor, is considered cured with minimal risk of recurrence.
9. Participant has active cardiovascular disease including, but not limited to:
 A medical history of deep vein thrombosis or pulmonary embolism within 1 month prior to randomization or any of the following within 6 months prior to randomization: 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 corrected QT interval by Fridericia’s (QTcF >470 msec), clinically significant cardiac arrhythmia (eg, atrial fibrillation with uncontrolled rate) or abnormalities in conduction or morphology of electrocardiogram (ECG) (eg, complete left bundle branch block, third- or second-degree heart block, PR interval >250 msec), or electrophysiologic disease (eg, placement of implantable cardioverter defibrillator).
 Any factors that increase the risk of corrected QT interval (QTc) prolongation or risk of arrhythmic events such as, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medications known to prolong QT interval or induce Torsades de Pointes.
 Uncontrolled (persistent) hypertension: systolic blood pressure >160 mm Hg; diastolic blood pressure >100 mm Hg.
 Congestive heart failure (CHF), defined as New York Heart Association (NYHA) class III-IV or hospitalization for CHF

The Estimated Number of Participants

  • Taiwan

    80 participants

  • Global

    1000 participants

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