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

Sponsor
OBI Pharma, Inc
Study ID
NCT05442060
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 30 μg OBI-833/100 μg OBI-821 — BIOLOGICAL
    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 Details

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.

Key Dates

First listed
Jul 1, 2022
Start date
Jul 27, 2022
Status verified
Jul 2025
Primary completion
Dec 31, 2025
Completion
May 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Erlotinib
    Erlotinib (150 mg daily)
  • Experimental: Erlotinib + OBI-833/OBI-821
    Erlotinib (150 mg daily) + 30 μg OBI-833/100 μg OBI-821

Primary Outcome Measure

Progression-free survival rated at one year [ Time Frame: One year ]

Central Contacts

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