BridgeMD
New treatment option for Non-small Cell Lung Cancer
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
ClinicalTrials.gov ID: NCT05442060
What this study is testing
What is 30 μg OBI-833/100 μg OBI-821?
30 μg OBI-833/100 μg OBI-821 is an investigational medicine, given as an once-weekly, being studied as a potential treatment for non-small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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. (e.g., type 1 juvenile...
See the full eligibility criteria
- 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...
- At least one measurable tumor lesion according to RECIST version 1.1 as assessed by the Investigator (local radiological image assessment).
- Life expectancy ≥ 6 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Organ Function Requirements - people 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...
- Understand and provide a written informed consent document according to institutional guidelines.
- 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. (e.g., type 1 juvenile onset diabetes mellitus, antibody positive for rheumatoid arthritis...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Taipei, Beitou District, Taiwan
- Taipei, Da'an Dist., Taiwan
- Taoyuan, Guishan Dist., Taiwan
- Taipei, Neihu District, Taiwan
- New Taipei City, Zhonghe District, Taiwan
- Taipei, Zhongzheng Dist., Taiwan
- Taichung, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taipei, Beitou District, Taiwan; Taipei, Da'an Dist., Taiwan; Taoyuan, Guishan Dist., Taiwan; Taipei, Neihu District, Taiwan; New Taipei City, Zhonghe District, Taiwan; Taipei, Zhongzheng Dist., Taiwan and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.