Clinical Trials

Title   Abbvie M16-289 (Tahoe)
Principal Investigator/ Physician   Moh’d Khushman, MD
Protocol No.   M16-289
Open Date   03/14/2017
Gender   Both
Cancer Site   Lung
Status   Open
Sponsor   AbbVie
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.


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