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

PHASE2RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

July 27, 2022

Primary Completion Date

December 31, 2025

Study Completion Date

May 31, 2026

Conditions
Non-small Cell Lung Cancer
Interventions
BIOLOGICAL

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.

DRUG

Erlotinib (150 mg daily)

All subjects in both arms will continue to receive erlotinib as the background therapy (150 mg daily).

Trial Locations (7)

106

RECRUITING

National Taiwan University Cancer Center, Taipei

333

RECRUITING

Linkou Chang Gung Memorial Hospital, Taoyuan District

11217

RECRUITING

Taipei Veterans General Hospital, Taipei

23561

RECRUITING

Shuang Ho Hospital, New Taipei City

40705

RECRUITING

Taichung Veterans General Hospital, Taichung

100229

RECRUITING

National Taiwan University Hospital, Taipei

114202

RECRUITING

Tri-Service General Hospital, Taipei

Sponsors

Lead Sponsor

All Listed Sponsors
lead

OBI Pharma, Inc

INDUSTRY