A Phase I Study of IRX4204 in Combination with Erlotinib in Patients with Previously Treated Advanced Non-Small Cell Lung Cancer
Patient selection: a) Pathological confirmation of non-small cell lung cancer without
activating EGFR mutations; b) Advanced stage disease (IV or IIIB with malignant effusion)
with at least two prior chemotherapy regimens; c) No available curative therapy; d) Pregnant
women are excluded; e) Informed consent.
Pretreatment evaluation: a) Medical history and physical examination; b) Hepatic and renal
function (bilirubin, aspartate aminotransaminase, creatinine); c) Preoperative staging
evaluation including CT-chest or PET/CT scan;
Treatment plan: Three dose levels of IRX4204 and erlotinib will be studied using
intra-patient dose escalation for dose levels 1 and 2. These study agents will be
administered orally until progression of disease, unacceptable toxicities, activation of a
phase II study of the combination, or exhaustion of the IRX4204 drug supply.
Evaluation on study: Adverse events will be graded on a scale of 0 to 5, using the Common
Terminology Criteria for Adverse Events (CTCAE) v. 4.0. Efficacy will be assessed using the
RECIST v1.1 criteria based on CT-chest or PET/CT scan after 8 weeks of study treatment.
View more details from ClinicalTrials.gov.
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