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

1. Aged ≥ 20 years.

2. Pathologically or cytologically confirmed diagnosis of non-small cell lung cancer whose stage is IIIB, IIIC, IVA, or IVB according to the AJCC Cancer Staging System, 8th Edition.

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

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

5. 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.

6. At least one measurable tumor lesion according to RECIST version 1.1 as assessed by the Investigator (local radiological image assessment).

7. Life expectancy ≥ 6 months.

8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

9. Organ Function Requirements - Subjects must have adequate organ functions as defined below:

* AST/ALT ≤ 3X ULN (upper limit of normal); AST/ALT ≤ 5X ULN in the presence of liver metastases

* Total bilirubin ≤ 2.0 X ULN

* Serum creatinine ≤ 1.5X ULN

* ANC ≥ 1,500 /µL

* Platelets ≥ 100,000/µL

10. All eligible patients of childbearing potential must use effective contraception during study treatment, and for at least 2 months after the last dose of OBI-833/OBI-821 and for at least 2 weeks after the last dose of erlotinib. Subjects not of childbearing potential (i.e., permanently sterilized, postmenopausal) can be included in the study. Postmenopausal is defined as 12 months with no menses without an alternative medical cause.

11. Understand and provide a written informed consent document according to institutional guidelines.

8. A history of other malignancies (except non-melanoma skin carcinoma, carcinoma in situ of the uterine cervix, follicular or papillary thyroid cancer) within 5 years prior to randomization.

9. Patient with any known uncontrolled comorbid illness including ongoing or active infections, symptomatic congestive heart failure (NYHA\>2), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

10. Treatment with any of the following therapies within 4 weeks prior to randomization:

* Anti-cancer therapies, including chemotherapy and targeted therapy (except erlotinib).

* Radiotherapy.

* Immunotherapy, including monoclonal antibodies, cytokines, interferons, and checkpoint inhibitors.

* Immunosuppressants, including cyclosporin, rapamycin, tacrolimus, rituximab, alemtuzumab, natalizumab, and cyclophosphamide.

* Other biologics, including G-CSF and other hematopoietic growth factors.

* Live attenuated vaccines.

* 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.

* Alternative and complementary medicine that may affect the immune system.

* Other investigational drugs.

11. Subject with pleural effusions and/or ascites, due to malignancy, requiring paracentesis every 2 weeks or more frequently.

12. Subject with any known severe allergies (e.g., anaphylaxis) to any active or inactive ingredients in the study drugs.

13. Any other reason that the investigator deems the patient to be unsuitable for the study.

What this study is about