Clinical Trial

To Evaluate OBI-833/OBI-821 in Combination With First-Line Erlotinib in Patients With EGFR-Mutated, Globo H-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Study acronym: EGFR
Recruiting Phase 2
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Record status
This record was last updated August 3, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
This study is a randomized, active control, open-label, phase 2 trial. Erlotinib-treated NSCLC patients will be screened for Globo H, and only Globo H+ (H score ≥ 100) subjects are eligible for the study. Eligible subjects who have been treated with 3±1 months of first-line erlotinib and have achieved stable disease (SD) or partial response (PR) status will be randomized in the ratio of 1:1 to receive erlotinib alone or erlotinib plus OBI-833/OBI-821 therapy.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-06-28; most recent amendment 2025-07-30.
Status change: Not Yet Recruiting → Recruiting 2022-09-23
Trial Details
NCT Number NCT05442060
Lead Sponsor OBI Pharma, Inc
Conditions Non-small Cell Lung Cancer
Enrollment 60 participants
Start Date 2022-07-27
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-05-31 (estimated)
Updated on ClinicalTrials.gov 2025-08-03