Non-small Cell Lung CancerPhase 2EGFRNCT05442060
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
A Phase 2 study testing 30 μg OBI-833/100 μg OBI-821 and Erlotinib (150 mg daily) in people with Non-small Cell Lung Cancer, run by OBI Pharma, Inc at 7 sites in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- 30 μg OBI-833/100 μg OBI-821 and Erlotinib (150 mg daily)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 7 sitesTaiwan
- Study dates
- 27 Jul 2022to 31 May 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 20 years.
- 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.
- The tumor harbors an exon 19 deletion or exon 21 L858R mutation in EGFR, confirmed locally.
- Patient must have a documented Globo H H-score of at least 100 using a validated central IHC assay.
- 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.
- At least one measurable tumor lesion according to RECIST version 1.1 as assessed by the Investigator (local radiological image assessment).
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- Life expectancy ≥ 6 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- 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
- 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.
- Understand and provide a written informed consent document according to institutional guidelines.
Who cannot join
- Patient who has CNS metastasis.
- Patient who is pregnant or breast-feeding at entry.
- Patient with splenectomy.
- Patient with HIV infection, active hepatitis B infection, or active hepatitis C infection.
- Patient with a positive test result for SARS-CoV-2 detected by standard reverse transcription-polymerase chain reaction (RT-PCR) at screening.
- Patient with any autoimmune or other disorders requiring IV/oral steroids or immunosuppressive or immunomodulatory therapies.
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- (e.g., type 1 juvenile onset diabetes mellitus, antibody positive for rheumatoid arthritis, Graves disease, Hashimoto thyroiditis, lupus, scleroderma, systemic vasculitis, hemolytic anemia, immune mediated thrombocytopenia, Crohn disease, ulcerative colitis, and psoriasis).
- Unresolved toxicities from prior anticancer therapy, defined as having not resolved to Grade 0 or 1 (using National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 5.0), except for alopecia and laboratory values listed in the inclusion criteria.
- 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.
- 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.
- 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.
- Subject with pleural effusions and/or ascites, due to malignancy, requiring paracentesis every 2 weeks or more frequently.
- Subject with any known severe allergies (e.g., anaphylaxis) to any active or inactive ingredients in the study drugs.
- Any other reason that the investigator deems the patient to be unsuitable for the study.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Taiwan7 sites, 7 recruiting
- Recruiting
Shuang Ho Hospital
New Taipei City, Zhonghe District, 23561
- Recruiting
Taichung Veterans General Hospital
Taichung, 40705
- Recruiting
Taipei Veterans General Hospital
Taipei, Beitou District, 11217
- Recruiting
National Taiwan University Cancer Center
Taipei, Da'an Dist., 106
- Recruiting
Tri-Service General Hospital
Taipei, Neihu District, 114202
- Recruiting
National Taiwan University Hospital
Taipei, Zhongzheng Dist., 100229
- Recruiting
Linkou Chang Gung Memorial Hospital
Taoyuan, Guishan Dist., 333
About this study
Official title: A Randomized, Open-Label, Phase 2 Study 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
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.
Read the detailed description
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.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- 30 μg OBI-833/100 μg OBI-821, Erlotinib (150 mg daily)
- Keywords
- OBI-833/OBI-821, Erlotinib, EGFR-Mutated, Globo H, Globo H positive, Locally advanced non-small cell lung cancer, Metastatic non-small cell lung cancer, NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30 μg OBI-833/100 μg OBI-821Biological
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.
Erlotinib (150 mg daily)Drug
All subjects in both arms will continue to receive erlotinib as the background therapy (150 mg daily).
| Study group | Role | What they receive |
|---|---|---|
| Erlotinib | Active comparator | Erlotinib (150 mg daily) Receives: Drug: Erlotinib (150 mg daily) |
| Erlotinib + OBI-833/OBI-821 | Experimental | Erlotinib (150 mg daily) + 30 μg OBI-833/100 μg OBI-821 Receives: Biological: 30 μg OBI-833/100 μg OBI-821; Drug: Erlotinib (150 mg daily) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival rated at one year
One year progression-free survival rated by RECIST 1.1 criteria
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start27 Jul 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OBI Pharma, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lance Ou, Study director, OBI Pharma, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442060
- Sponsor's protocol ID
- OBI-833-003
- Acronym
- EGFR
- Status last verified
- Jul 2025
- First submitted
- 28 Jun 2022
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Phase 2 Study 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
- ClinicalTrials.gov ID
- NCT05442060
- Acronym / sponsor ID
- EGFR / OBI-833-003
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- OBI-833/OBI-821, Erlotinib, EGFR-Mutated, Globo H, Globo H positive, Locally advanced non-small cell lung cancer, Metastatic non-small cell lung cancer, NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- OBI Pharma, IncIndustry (pharma, biotech, devices)
- Study start
- 27 Jul 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 1 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erlotinib | Active comparator | Drug: Erlotinib (150 mg daily)Erlotinib (150 mg daily) |
| Erlotinib + OBI-833/OBI-821 | Experimental | Biological: 30 μg OBI-833/100 μg OBI-821, Drug: Erlotinib (150 mg daily)Erlotinib (150 mg daily) + 30 μg OBI-833/100 μg OBI-821 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Aged ≥ 20 years.
- 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.
- The tumor harbors an exon 19 deletion or exon 21 L858R mutation in EGFR, confirmed locally.
- Patient must have a documented Globo H H-score of at least 100 using a validated central IHC assay.
- 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.
Key exclusion criteria (23 listed)
- Patient who has CNS metastasis.
- Patient who is pregnant or breast-feeding at entry.
- Patient with splenectomy.
- Patient with HIV infection, active hepatitis B infection, or active hepatitis C infection.
- Patient with a positive test result for SARS-CoV-2 detected by standard reverse transcription-polymerase chain reaction (RT-PCR) at screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 30 μg OBI-833/100 μg OBI-821Each 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. | Biological | Erlotinib + OBI-833/OBI-821 |
| Erlotinib (150 mg daily)All subjects in both arms will continue to receive erlotinib as the background therapy (150 mg daily). | Drug | Erlotinib, Erlotinib + OBI-833/OBI-821 |
Primary outcome
Progression-free survival rated at one year
Time frame: One year
One year progression-free survival rated by RECIST 1.1 criteria
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lance Ou study director
OBI Pharma, Inc
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 30 μg OBI-833/100 μg OBI-821 and Erlotinib (150 mg daily) in people with Non-small Cell Lung Cancer, run by OBI Pharma, Inc at 7 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Hu (886-2-27866589 ext. 104, annahu@obipharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival rated at one year (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.