60
Participants
Start Date
July 27, 2022
Primary Completion Date
December 31, 2025
Study Completion Date
May 31, 2026
30 μg OBI-833/100 μg OBI-821
Each subject in the OBI-833/OBI-821 + erlotinib combination arm will be treated with OBI-833/OBI-821 weekly for 4 doses (Weeks 1, 2, 3, 4), then every 2 weeks for 2 doses (Weeks 6, 8), then every 4 weeks for 4 doses (Weeks 12, 16, 20, 24), and then every 8 weeks until documented disease progression, intolerable adverse events (AEs)/toxicity, consent withdrawal, death, loss to follow-up, or up to 80 weeks from randomization.
Erlotinib (150 mg daily)
All subjects in both arms will continue to receive erlotinib as the background therapy (150 mg daily).
RECRUITING
National Taiwan University Cancer Center, Taipei
RECRUITING
Linkou Chang Gung Memorial Hospital, Taoyuan District
RECRUITING
Taipei Veterans General Hospital, Taipei
RECRUITING
Shuang Ho Hospital, New Taipei City
RECRUITING
Taichung Veterans General Hospital, Taichung
RECRUITING
National Taiwan University Hospital, Taipei
RECRUITING
Tri-Service General Hospital, Taipei
Lead Sponsor
OBI Pharma, Inc
INDUSTRY