|Title||Abbvie M16-289 (Tahoe)|
|Principal Investigator/ Physician||Moh’d Khushman, MD|
|Contact Email||MCI Clinical Trials|
Protocol: A Randomized, Open-Label, Multicenter, Phase 3 Study of Rovalpituzumab Tesirine Compared with Topotecan for Subjects with Advanced or Metastatic DLL3high Small Cell Lung Cancer (SCLC) who have First Disease Progression During or Following Front-Line Platinum-Based Chemotherapy (TAHOE)
Inclusion Criteria: Histologically or cytologically confirmed advanced or metastatic Small Cell Lung Cancer (SCLC) with documented first disease progression during or following front-line platinum-based systemic regimen; High Delta-like protein 3 (DLL3) expression defined as having ≥ 75% tumor cells staining positive; Must have measurable disease; must have measurable disease; Recovery to Grade 0 or 1 of any clinically significant toxicity (excluding alopecia) prior to initiation of study drug administration.
Exclusion Criteria: Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms; known leptomeningeal metastases; Received more than one prior systemic therapy regimen for SCLC; Serious infection within 2 weeks prior to randomization, including any Grade 3 or higher viral, bacterial, or fungal infection; History of active malignancies other than SCLC within the past 2 years prior to study entry, with the exception of in situ cancer which was curatively treated; Prior exposure to topotecan, irinotecan or any other topoisomerase I inhibitors.
Clinical Trials.Gov Link: https://clinicaltrials.gov/ct2/show/NCT03061812?term=M16-289&recrs=a&rank=1
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