A Phase 2, Open-Label, Parallel Cohort Study of Subcutaneous Amivantamab in Multiple Regimens in Patients with Advanced or Metastatic Solid Tumors including EGFR-mutated Non-Small Cell Lung Cancer.

Inclusion Criteria

- 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, 3, 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. Cohorts 1,5,and6: 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 3and3b: 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 tyrosine kinase inhibitor (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. 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

- 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 If only 1 non-irradiated measurable lesion

exists, which undergoes a biopsy and is acceptable as a target lesion, the baseline

tumor assessment scans should be performed at least 14 days after the biopsy

- 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)

- Have adequate organ (renal, hepatic, hematological, coagulation and cardiac) functions

- Participant must have eastern cooperative oncology group (ECOG) status of 0 or 1

- 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

- 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. Female participants should

consider preservation of eggs prior to study treatment as anti-cancer treatments may

impair fertility

Exclusion Criteria

- Participant has a medical history of interstitial lung disease (ILD), including drug

induced ILD or radiation pneumonitis

- Participant has a history of hypersensitivity to any excipients of the investigational

products to be used in their enrollment cohort

- Participant has received a live or live attenuated vaccine within 3 months before

Cycle 1 Day 1. The seasonal influenza vaccine and non-live vaccines against

Coronavirus disease 19 (COVID-19) are not exclusionary

- 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

- Other clinically active liver disease of infectious origin

- 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

- 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