All subjects in both arms will continue to receive erlotinib as the background therapy. 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. Subjects in the OBI-833/OBI-821 + erlotinib arm will be evaluated for humoral immune responses until disease progression. Upon completion of or discontinuation from the study treatment, all subjects will be followed up for survival by phone call every 3 months until up to 12 months after the end of treatment (EoT) visit.
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.