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 (EGFR)

  • STATUS
    Recruiting
  • End date
    May 31, 2026
  • participants needed
    60
  • sponsor
    OBI Pharma, Inc
Updated on 12 October 2022
erlotinib
EGFR
lung carcinoma

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. 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.

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.

Details
Condition Non-small Cell Lung Cancer
Treatment 30 μg OBI-833/100 μg OBI-821, Erlotinib (150 mg daily)
Clinical Study IdentifierNCT05442060
SponsorOBI Pharma, Inc
Last Modified on12 October 2022

Eligibility

Yes No Not Sure

Inclusion 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 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)
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

Exclusion Criteria

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, 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
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