Study CA239-0006 is an open-label, randomized Phase 3 clinical trial comparing the efficacy of MRTX849 administered in combination with cetuximab versus chemotherapy in the second-line treatment setting in patients with CRC with KRAS G12C mutation.
Study CA239-0006 is an open-label, randomized Phase 3 clinical trial comparing the efficacy of MRTX849 administered in combination with cetuximab versus chemotherapy in the second-line treatment setting in patients with CRC with KRAS G12C mutation.
Inclusion Criteria:
Exclusion Criteria:
{ "desc": [ {"id": "1", "text": "Study CA239-0006 is an open-label, randomized Phase 3 clinical trial comparing the efficacy of MRTX849 administered in combination with cetuximab versus chemotherapy in the second-line treatment setting in patients with CRC with KRAS G12C mutation."} ], "crit": [ {"id": "1", "type": "inc", "text": "Histologically confirmed diagnosis of colorectal carcinoma with KRAS G12C mutation in tumor tissue."}, {"id": "2", "type": "inc", "text": "Prior receipt of 1st line treatment in advanced CRC with a fluoropyrimidine-based chemotherapy regimen containing either oxaliplatin or irinotecan, and radiographically documented progression of disease on or after treatment."}, {"id": "3", "type": "exc", "text": "Prior treatment with a therapy targeting KRAS G12C mutation (e.g., AMG 510)."}, {"id": "4", "type": "exc", "text": "Prior treatment with an anti-EGFR antibody (e.g., cetuximab or panitumumab)."}, {"id": "5", "type": "exc", "text": "Active brain metastasis"} ] }
{
"extractedEligibilityCriteria": {
"inclusionCriteria": [
{
"number": 1,
"criterion": "Histologically confirmed diagnosis of colorectal carcinoma with KRAS G12C mutation in tumor tissue."
},
{
"number": 2,
"criterion": "Prior receipt of 1st line treatment in advanced CRC with a fluoropyrimidine-based chemotherapy regimen containing either oxaliplatin or irinotecan, and radiographically documented progression of disease on or after treatment."
}
],
"exclusionCriteria": [
{
"number": 1,
"criterion": "Prior treatment with a therapy targeting KRAS G12C mutation (e.g., AMG 510)."
},
{
"number": 2,
"criterion": "Prior treatment with an anti-EGFR antibody (e.g., cetuximab or panitumumab)."
},
{
"number": 3,
"criterion": "Active brain metastasis."
}
]
},
"fhirQueryPredicates": {
"inclusionCriteriaPredicates": [
{
"criterionNumber": 1,
"order": 1,
"fhirPredicate": "_has:Condition:patient:code=http%3A%2F%2Fsnomed.info%2Fsct%7C363406005&_has:Observation:patient:code=http%3A%2F%2Floinc.org%7C81247-9",
"explanation": "Diagnosis of colorectal carcinoma (SNOMED CT: 363406005) with KRAS G12C mutation (LOINC: 81247-9)."
},
{
"criterionNumber": 2,
"order": 2,
"fhirPredicate": "_has:MedicationStatement:patient:medication.code=http%3A%2F%2Frxnorm.info%2F%7C308056&_has:MedicationStatement:patient:medication.code=http%3A%2F%2Frxnorm.info%2F%7C308057",
"explanation": "Prior treatment with oxaliplatin (RxNorm: 308056) or irinotecan (RxNorm: 308057) in a fluoropyrimidine-based regimen."
}
],
"exclusionCriteriaPredicates": [
{
"criterionNumber": 1,
"order": 1,
"fhirPredicate": "_has:MedicationStatement:patient:medication.code:not=http%3A%2F%2Frxnorm.info%2F%7C2265747",
"explanation": "No prior treatment with AMG 510 (RxNorm: 2265747)."
},
{
"criterionNumber": 2,
"order": 2,
"fhirPredicate": "_has:MedicationStatement:patient:medication.code:not=http%3A%2F%2Frxnorm.info%2F%7C1802&_has:MedicationStatement:patient:medication.code:not=http%3A%2F%2Frxnorm.info%2F%7C1803",
"explanation": "No prior treatment with cetuximab (RxNorm: 1802) or panitumumab (RxNorm: 1803)."
},
{
"criterionNumber": 3,
"order": 3,
"fhirPredicate": "_has:Condition:patient:code:not=http%3A%2F%2Fsnomed.info%2Fsct%7C443527001",
"explanation": "No active brain metastasis (SNOMED CT: 443527001)."
}
]
},
"rationale": {
"assumptions": [
"KRAS G12C mutation is recorded as a genetic observation.",
"Fluoropyrimidine-based chemotherapy regimens are inferred from the presence of oxaliplatin or irinotecan."
],
"notes": [
"Reverse chaining is used to connect Patient resources with related Condition, Observation, and MedicationStatement resources.",
"URL encoding is applied to special characters in FHIR predicates to ensure proper query execution."
]
}
}