RecruitingPhase 3NCT06382129

A Study Comparing BL-B01D1 With Docetaxel in Patients With Unresectable Locally Advanced or Metastatic EGFR Wild-type Non-small Cell Lung Cancer

A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Docetaxel in Patients With Unresectable Locally Advanced or Metastatic EGFR Wild-type Non-small Cell Lung Cancer After Failure of Anti-PD-1/PD-L1 Monoclonal Antibodies and Platinum-based Chemotherapy


Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

680 participants

Start Date

May 17, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This trial is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with locally advanced or metastatic EGFR wild-type non-small cell lung cancer after failure of anti-PD-1/PD-L1 monoclonal antibodies and platinum-based chemotherapy.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial compares a new antibody-drug conjugate called BL-B01D1 (which delivers chemotherapy directly to cancer cells) with the standard chemotherapy drug docetaxel in patients with advanced non-small cell lung cancer that does not have the EGFR gene mutation. **You may be eligible if...** - You are 18 or older - You have locally advanced or metastatic non-small cell lung cancer without an EGFR mutation, confirmed by tissue testing - Your cancer can be measured on scans - You are in good general health (ECOG 0-1) - Your heart, liver, kidney, and blood function are adequate - Your expected survival is at least 3 months **You may NOT be eligible if...** - Your tumor has an EGFR mutation - You have severe heart problems or low heart pumping function - Your organ function is inadequate - You have unresolved side effects from prior cancer treatment 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.

DRUGDocetaxel

Administration by intravenous infusion for a cycle of 3 weeks.


Locations(1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

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NCT06382129


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