Actively Recruiting
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
Led by OBI Pharma, Inc · Updated on 2025-08-03
60
Participants Needed
7
Research Sites
200 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 20 years or older
- Diagnosed with non-small cell lung cancer stage IIIB, IIIC, IVA, or IVB
- Tumor has exon 19 deletion or exon 21 L858R EGFR mutation
- Globo H H-score of at least 100 confirmed by central assay
- Received 3±1 months of first-line erlotinib at stable 150 mg/day, with stable disease or partial response
- At least one measurable tumor lesion per RECIST 1.1
- Life expectancy at least 6 months
- ECOG performance status 0 or 1
- Adequate organ function: AST/ALT ≤3x ULN (≤5x with liver metastases), total bilirubin ≤2x ULN, serum creatinine ≤1.5x ULN, ANC ≥1500/µL, platelets ≥100,000/µL
- Use effective contraception if of childbearing potential during and after treatment as specified
- Able to understand and provide written informed consent
You will not qualify if you...
- Presence of central nervous system metastasis
- Pregnant or breastfeeding at study entry
- History of splenectomy
- HIV infection or active hepatitis B or C infection
- Positive SARS-CoV-2 test at screening
- Autoimmune or other disorders needing intravenous/oral steroids or immunosuppressive therapies
- Unresolved toxicities from prior anticancer therapy above Grade 1 except alopecia and allowed labs
- Other malignancies within 5 years except certain skin, cervical, and thyroid cancers
- Uncontrolled comorbid illnesses including active infections, severe heart conditions, arrhythmias, or psychiatric/social issues limiting study compliance
- Treatment with anti-cancer therapies, radiotherapy, immunotherapy, immunosuppressants, biologics, live vaccines, certain steroids, alternative medicines, or investigational drugs within 4 weeks prior to randomization
- Frequent paracentesis for pleural effusions or ascites due to cancer
- Severe allergies to any study drug components
- Any other investigator-determined reason making the patient unsuitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Taipei Veterans General Hospital
Taipei, Beitou District, Taiwan, 11217
Actively Recruiting
2
National Taiwan University Cancer Center
Taipei, Da'an Dist., Taiwan, 106
Actively Recruiting
3
Linkou Chang Gung Memorial Hospital
Taoyuan, Guishan Dist., Taiwan, 333
Actively Recruiting
4
Tri-Service General Hospital
Taipei, Neihu District, Taiwan, 114202
Actively Recruiting
5
Shuang Ho Hospital
New Taipei City, Zhonghe District, Taiwan, 23561
Actively Recruiting
6
National Taiwan University Hospital
Taipei, Zhongzheng Dist., Taiwan, 100229
Actively Recruiting
7
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Actively Recruiting
Research Team
A
Anna Hu
CONTACT
L
Lance Ou
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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