{
"info": {
"nct_id": "NCT04487080",
"official_title": "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.",
"inclusion_criteria": "* Participant must have newly diagnosed histologically or cytologically confirmed, locally advanced or metastatic non-small cell lung cancer (NSCLC) that is treatment naive and not amenable to curative therapy including surgical resection or chemoradiation\n* The tumor harbors exon 19 deletions (Exon 19del) or Exon 21 L858R substitution, as detected by an food and drug administration (FDA)-approved or other validated test 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) in accordance with site standard of care\n* Mandatory submission of unstained tissue from tumor (in a quantity sufficient to allow for central analysis of EGFR mutation status and blood (for circulating tumor deoxyribonucleic acid [ctDNA], digital droplet polymerase chain reaction [ddPCR], and pharmacogenomic analysis)\n* Any toxicities from prior anticancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) Grade 1 or baseline level\n* Participant must have at least 1 measurable lesion, according to response evaluation criteria in solid tumors (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\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Participant has received any prior systemic treatment at any time for locally advanced Stage III or metastatic Stage IV disease (adjuvant or neoadjuvant therapy for Stage I or II disease is allowed, if administered more than 12 months prior to the development of locally advanced or metastatic disease)\n* Participant has an active or past medical history of leptomeningeal disease\n* Participant with untreated spinal cord compression. A participant that has been definitively treated with surgery or radiation and has a stable neurological status for at least 2 weeks prior to randomization is eligible provided they are off corticosteroid treatment or receiving low-dose corticosteroid treatment less than or equal to (<=) 10 milligrams per day (mg/day) prednisone or equivalent\n* Participant has an active or past medical history of interstitial lung disease (ILD)/pneumonitis, including drug-induced or radiation ILD/pneumonitis\n* Participant has known allergy, hypersensitivity, or intolerance to the excipients used in formulation of amivantamab, lazertinib, or osimertinib, or any contraindication to the use of osimertinib\n* Participant has symptomatic brain metastases. A participant with asymptomatic or previously treated and stable brain metastases may participate in this study",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* The tumor harbors exon 19 deletions (Exon 19del) or Exon 21 L858R substitution, as detected by an food and drug administration (FDA)-approved or other validated test 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) in accordance with site standard of care",
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},
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"exact_snippets": "tumor harbors ... Exon 21 L858R substitution",
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"criterions": [
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"exact_snippets": "Mandatory submission of unstained tissue from tumor",
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}
},
{
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"requirement": {
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}
},
{
"exact_snippets": "sufficient to allow for ... digital droplet polymerase chain reaction [ddPCR]",
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"expected_value": true
}
},
{
"exact_snippets": "sufficient to allow for ... pharmacogenomic analysis",
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"and_criteria": [
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"line": "* Participant must have at least 1 measurable lesion, according to response evaluation criteria in solid tumors (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",
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"unit": "N/A"
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"and_criteria": [
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"and_criteria": [
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"and_criteria": [
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"and_criteria": [
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}
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}
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"criterions": [
{
"exact_snippets": "known allergy, hypersensitivity, or intolerance to the excipients used in formulation of amivantamab, lazertinib, or osimertinib",
"criterion": "allergy, hypersensitivity, or intolerance to excipients",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "any contraindication to the use of osimertinib",
"criterion": "contraindication to osimertinib",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "known allergy, hypersensitivity, or intolerance to the excipients used in formulation of amivantamab, lazertinib, or osimertinib",
"criterion": "allergy, hypersensitivity, or intolerance to excipients",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"exact_snippets": "any contraindication to the use of osimertinib",
"criterion": "contraindication to osimertinib",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Participant has symptomatic brain metastases. A participant with asymptomatic or previously treated and stable brain metastases may participate in this study",
"criterions": [
{
"exact_snippets": "Participant has symptomatic brain metastases",
"criterion": "symptomatic brain metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "asymptomatic or previously treated and stable brain metastases",
"criterion": "asymptomatic or previously treated and stable brain metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "Participant has symptomatic brain metastases",
"criterion": "symptomatic brain metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
"then_criteria": {
"not_criteria": {
"exact_snippets": "asymptomatic or previously treated and stable brain metastases",
"criterion": "asymptomatic or previously treated and stable brain metastases",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
},
"else_criteria": null
}
}
],
"failed_miscellaneous": []
}