lazertinib for Non-small cell lung cancer (EGFR-mutated) | Advanced or metastatic solid tumors

Inclusion criteria

• {"criterion_text":"- Participant must have histologically or cytologically confirmed, locally advanced or metastatic, non-small cell lung cancer (NSCLC) that is not amenable to curative therapy including surgical resection or chemoradiation. Additional Cohort specific disease requirements include: Cohorts 1, 3b, 5, 6 and 7: epidermal growth factor receptor (EGFR) exon 19 deletion (Exon19del) or Exon 21 L858R mutation; Cohort 2: EGFR Exon 20ins mutation.\n- Cohorts 1, 5, and 6: Participant should not have received any prior systemic therapy for locally advanced or metastatic NSCLC. Cohort 2: Participant should not have received any prior systemic therapy for locally advanced or metastatic NSCLC. Cohorts 3 and 3b: Participant must have progressed on or after osimertinib monotherapy as the most recent line of treatment. Osimertinib must have been administered as either the first-line treatment for locally advanced or metastatic disease or in the second-line setting after prior treatment with first- or second-generation EGFR TKI as a monotherapy. Cohort 4: Participants need to currently be on an amivantamab IV Q2W regimen (1,050 mg or 1,400 mg depending on weight) for at least 8 weeks, as part of standard of care, an expanded access program, or as a rollover from a long-term extension, without any amivantamab dose reduction. Cohort 7: Participants must have progressed on or after the combination of amivantamab and lazertinib as the most recent line of treatment. The combination of amivantamab and lazertinib must have been administered as the first-line treatment for locally advanced or metastatic disease.\n- Cohort 2, 3, 3b, and 7 only: Squamous NSCLC are excluded. EGFR mutation must have been identified as determined by Food and Drug Administration (FDA) approved or other validated test of either circulating tumor deoxyribonucleic acid (ctDNA) or tumor tissue in a clinical laboratory improvement amendments (CLIA) certified laboratory (sites in the United states [US]) or an accredited local laboratory (sites outside of the US). A copy of the initial test report documenting the EGFR mutation must be included in the participant records and a deidentified copy must also be submitted to the sponsor\n- All cohorts except Cohort 4: Participants must have at least 1 measurable lesion, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. If the only target lesion has been previously irradiated, it must show signs of disease progression since radiation was completed.\n- May have a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)\n- Have adequate organ (renal, hepatic, hematological, coagulation and cardiac) functions\n- Participant must have eastern cooperative oncology group (ECOG) status of 0 or 1\n- Cohort 6: Must be eligible for, and agree to comply with, the use of prophylactic anticoagulation with a direct oral anticoagulant or a low molecular weight heparin during the first 4 months of study treatment\n- A participant must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for a period of 6 months after receiving the last dose of study treatment. Participants should consider preservation of eggs prior to study treatment as anti-cancer treatments may impair fertility"}

Exclusion criteria

• {"criterion_text":"- Participant has a medical history of interstitial lung disease (ILD), including drug induced ILD or radiation pneumonitis\n- Participant has a history of hypersensitivity to any excipients of the investigational products to be used in their enrollment cohort\n- Participant has received a live or live attenuated vaccine within 3 months before Cycle 1 Day 1. The seasonal influenza vaccine and nonlive vaccines against Coronavirus disease 19 (COVID-19) are not exclusionary\n- For all cohorts with regimens potentially including lazertinib: Participant is currently receiving medications or herbal supplements known to be potent Cytochrome (CYP3A4/5) inducers and is unable to stop use for an appropriate washout period prior to Cycle 1 Day 1\n- Other clinically active liver disease of infectious origin\n- Participant has a history of clinically significant cardiovascular disease including, but not limited to: a) All cohorts: diagnosis of deep vein thrombosis or pulmonary embolism within 1 month prior to the first dose of study treatment(s), or any of the following within 6 months prior to the first dose of study treatment(s): 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; b) All cohorts with regimens potentially including lazertinib: Participant has a significant genetic predisposition to venous thromboembolic events (VTE; such as Factor V Leiden); c) All cohorts with regimens potentially including lazertinib: Participant has a prior history of VTE and is not on appropriate therapeutic anticoagulation as per NCCN or local guidelines; d) prolonged corrected QT interval by Fridericia (QTcF) interval greater than (>) 480 milliseconds (msec) or clinically significant cardiac arrhythmia or electrophysiologic disease (example, placement of implantable cardioverter defibrillator or atrial fibrillation with uncontrolled rate); e) uncontrolled (persistent) hypertension: systolic blood pressure >160 millimeter(s) of mercury (mmHg); diastolic blood pressure >100 mmHg; f) Congestive heart failure defined as NYHA class III-IV or hospitalization for congestive heart failure (CHF) (any New York Heart Association [NYHA] class) within 6 months of treatment initiation at Cycle 1/day 1 (C1D1); g) pericarditis/clinically significant pericardial effusion; h) myocarditis; i) baseline left ventricular ejection fraction (LVEF) below the institution's lower limit of normal at screening, as assessed by echocardiogram or multigated acquisition (MUGA) scan\n- 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 (less than or equal to [<=] 10 milligrams per day [mg/day] prednisone or equivalent) for at least 2 weeks prior to treatment allocation"}

Primary endpoints

• {"endpoint_text":"- ORR (INV)","definition_or_measurement_approach":"Objective response rate as assessed by investigator (INV); measurable disease assessed per RECIST v1.1 (RECIST v1.1 referenced in inclusion criteria)."}

Spain

Earliest CTIS Part Ii Submission Date

25-01-2024

Latest Decision Or Authorization Date

26-03-2026

Processing Time Days

791

Number Of Sites

14

Number Of Participants

51

Germany

Earliest CTIS Part Ii Submission Date

25-01-2024

Latest Decision Or Authorization Date

24-02-2026

Processing Time Days

761

Number Of Sites

4

Number Of Participants

12

France

Earliest CTIS Part Ii Submission Date

25-01-2024

Latest Decision Or Authorization Date

20-02-2026

Processing Time Days

757

Number Of Sites

5

Number Of Participants

25

Italy

Earliest CTIS Part Ii Submission Date

25-01-2024

Latest Decision Or Authorization Date

24-02-2026

Processing Time Days

761

Number Of Sites

5

Number Of Participants

10

Primary sponsor

Full Name

Janssen - Cilag International

Organisation Type

Pharmaceutical company

Country Of Registered Address

Belgium

Contract research organisations

Name

Pharmaceutical Research Associates Group B.V.

Responsibilities

Sponsor duties code: 4 (per CTIS listing)

Name

Imperial Clinical Research Services International Ltd.

Responsibilities

Paper PRO printing and distribution to sites.

Name

Parexel International (IRL) Limited

Responsibilities

Sponsor duties code: 6 (per CTIS listing)

Name

Almac Clinical Technologies LLC

Responsibilities

Drug-site supply, inventory, subject status management, site activation/closure; other listed duties

Name

Bioclinica Inc.

Responsibilities

Central imaging services (Medical image analysis/ review) - CT, MRI, etc.

Name

Venn Life Sciences Ed B.V.

Responsibilities

Sponsor duties code: 4 (per CTIS listing)

Third parties

• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"Netherlands","full_name":"Pharmaceutical Research Associates Group B.V.","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Imperial Clinical Research Services International Ltd.","duties_or_roles":"Paper PRO printing and distribution to sites.","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"codes: 14, 15 (Drug-site supply, inventory, subject status management, site activation/closure), 3","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Smithers PDS LLC","duties_or_roles":"code: 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"code: 6","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Myriad RBM Inc.","duties_or_roles":"code: 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"code: 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Netherlands","full_name":"Venn Life Sciences Ed B.V.","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central imaging services (Medical image analysis/ review) - CT, MRI, etc.","organisation_type":"Laboratory/Research/Testing facility"}