RecruitingPhase 2NCT05442060

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 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

Sponsor

OBI Pharma, Inc

Enrollment

60 participants

Start Date

Jul 27, 2022

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer

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.

Eligibility

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a cancer vaccine (OBI-833 combined with an immune booster OBI-821) given alongside the targeted therapy erlotinib, for people with non-small cell lung cancer (NSCLC) that has a specific genetic mutation (EGFR) and a specific protein on the tumor surface (Globo H). **You may be eligible if...** - You are 20 years or older - You have been diagnosed with advanced (stage IIIB, IIIC, IVA, or IVB) non-small cell lung cancer - Your tumor has a specific EGFR mutation (exon 19 deletion or L858R) - Your tumor tests positive for a protein called Globo H - You have already been on erlotinib for about 3 months with stable or improving disease - You have at least one measurable tumor **You may NOT be eligible if...** - Your tumor has progressed on erlotinib - You have active brain metastases - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICAL30 μg OBI-833/100 μg OBI-821

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.

DRUGErlotinib (150 mg daily)

All subjects in both arms will continue to receive erlotinib as the background therapy (150 mg daily).