RecruitingPhase 2NCT06498986

A Study of BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer


Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

40 participants

Start Date

Jul 31, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II clinical study is a study to explore the efficacy and safety of BL-B01D1 in combination with Osimertinib Mesylate Tablets in patients with histologically and/or cytologically confirmed locally advanced or metastatic non-small cell lung cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining a new antibody-drug conjugate called BL-B01D1 with osimertinib (a targeted lung cancer drug) is safe and effective in people with advanced non-small cell lung cancer that has specific EGFR gene mutations. **You may be eligible if...** - You are 18 or older with confirmed locally advanced or metastatic non-small cell lung cancer - Your tumor has a confirmed EGFR-sensitizing mutation (from tissue or blood test) - You have at least one measurable tumor and your expected survival is at least 3 months - Your general health score and organ function are adequate - You are willing to provide a tumor tissue sample **You may NOT be eligible if...** - Your tumor does not have an EGFR mutation - You have active brain metastases, serious lung inflammation, or uncontrolled infections - You have previously received osimertinib or similar EGFR-targeting drugs (depending on study phase) - 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

DRUGBL-B01D1

Administration by intravenous infusion for a cycle of 3 weeks.

DRUGOsimertinib Mesylate Tablets

Oral administration, 80mg daily for a cycle of 3 weeks.


Locations(1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

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NCT06498986


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