NCT05863325

A Study to Compare the Efficacy and Safety of HB1801 to Taxotere in Advanced Non-Small Cell Lung Cancer (NSCLC)

An Open-label, Randomized, Positive Drug-controlled Phase Ⅱ Study to Compare the Efficacy and Safety of HB1801 to Taxotere in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, randomized, positive drug-controlled Phase Ⅱ clinical study to compare the efficacy and safety of HB1801 to Taxotere in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed platinum- containing chemotherapies.

Detailed description

Eligible patients will enter the screening period up to 28 days before the start of treatment. Patients will be randomized in a 1:1 ratio to receive HB1801 (trial group) or Taxotere (control group). Randomized stratification factor is pathological type (squamous vs. non-squamous). Patients in trial group will receive HB 1801 and patients in control group will receive Taxotere. HB 1801 or Taxotere will be given on the first day of each cycle (21 days). Each patient will be treated until documented disease progression, discontinuation due to toxicity, withdrawal of consent, initiation of a new antitumor therapy, loss of follow-up, death, or study completion, whichever occurs first.

Conditions

• Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	HB1801	HB1801 will be administered by intravenous (IV) injections on the first day of each cycle.
DRUG	Taxotere	Taxotere will be administered by intravenous (IV) injections on the first day of each cycle.

Timeline

• Start date: 2023-06-27
• Primary completion: 2024-03-01
• Completion: 2024-09-01
• First posted: 2023-05-18
• Last updated: 2023-11-07

Locations

1 site across 1 country: China