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

Required: EGFR exon 19 deletion

The tumor harbors an exon 19 deletion or exon 21 L858R mutation in EGFR, confirmed locally.

Required: EGFR L858R

The tumor harbors an exon 19 deletion or exon 21 L858R mutation in EGFR, confirmed locally.

Required: GLB1 Globo H H-score ≥ 100 by validated central IHC assay (H-score ≥ 100)

Patient must have a documented Globo H H-score of at least 100 using a validated central IHC assay.

Must have received: EGFR tyrosine kinase inhibitor (erlotinib) — first-line

Patient must have received 3±1 months of first-line erlotinib therapy under a stable dosage of 150 mg/day, have achieved SD or PR before randomization (as confirmed by the Investigator), and plan to continue the erlotinib treatment at 150 mg/day.

Cannot have received: anti-cancer therapies (except erlotinib)

Exception: erlotinib

Anti-cancer therapies, including chemotherapy and targeted therapy (except erlotinib) within 4 weeks prior to randomization

Cannot have received: radiotherapy

Radiotherapy within 4 weeks prior to randomization

Cannot have received: immunotherapy (monoclonal antibodies, cytokines, interferons, checkpoint inhibitors)

Immunotherapy, including monoclonal antibodies, cytokines, interferons, and checkpoint inhibitors within 4 weeks prior to randomization

Cannot have received: immunosuppressants (cyclosporin, rapamycin, tacrolimus, rituximab, alemtuzumab, natalizumab, cyclophosphamide)

Immunosuppressants, including cyclosporin, rapamycin, tacrolimus, rituximab, alemtuzumab, natalizumab, and cyclophosphamide within 4 weeks prior to randomization

Cannot have received: other biologics (G-CSF, other hematopoietic growth factors)

Other biologics, including G-CSF and other hematopoietic growth factors within 4 weeks prior to randomization

Cannot have received: live attenuated vaccines

Live attenuated vaccines within 4 weeks prior to randomization

Cannot have received: steroids

Exception: single prophylactic use in CT/MRI scan or other one-time use in approved indications; inhaled and topical (except on the injection site) steroids allowed

IV/oral steroids except single prophylactic use in CT/MRI scan or other one-time use in approved indications. Use of inhaled and topical (except on the injection site) steroids is allowed.

Cannot have received: alternative and complementary medicine that may affect the immune system

Alternative and complementary medicine that may affect the immune system within 4 weeks prior to randomization

Cannot have received: other investigational drugs

Other investigational drugs within 4 weeks prior to randomization