Adebrelimab Combined With Bevacizumab and Docetaxel for Advanced Non-Squamous Non-small Cell Lung Cancer After Progression on First-line Immunotherapy

Sponsor
The First Affiliated Hospital of Xinxiang Medical College
Study ID
NCT06182800
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Adebrelimab Combined with Bevacizumab and Docetaxel — DRUG
    Adebrelimab: 1200 mg Adebrelimab is given on day 1 of each cycle, with 1 dosing cycle every 3 weeks. The dosing time window may be ±5 days, but within 72 hours before each dose, subjects must complete an examination including all clinically necessary tests to assess tolerability of continued dosing, in addition to imaging. Subjects are also advised to remain in the hospital for observation 72 hours after the first dose. Bevacizumab: 7.5 mg/kg Bevacizumab administered intravenously on day 1 of each cycle, with 1 dosing cycle every 3 weeks. Docetaxel: 60-75 mg/m2 Docetaxel is given on days 1 of each cycle by intravenous infusion for 1 dosing cycle every 3 weeks.

Study Details

This study is a prospective, single-arm, multicenter, phase II clinical study to observe and evaluate the efficacy and safety of adebrelimab in combination with bevacizumab and docetaxel in patients with advanced non-squamous NSCLC after progression on first-line immunotherapy.

Key Dates

First listed
Dec 27, 2023
Start date
Dec 27, 2023
Status verified
Dec 2023
Primary completion
Jun 30, 2025
Completion
Dec 30, 2025

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Adebrelimab Combined with Bevacizumab and Docetaxel
    Adebrelimab: 1200 mg Adebrelimab is given on day 1 of each cycle, with 1 dosing cycle every 3 weeks. The dosing time window may be ±5 days, but within 72 hours before each dose, subjects must complete an examination including all clinically necessary tests to assess tolerability of continued dosing, in addition to imaging. Subjects are also advised to remain in the hospital for observation 72 hours after the first dose. Bevacizumab: 7.5 mg/kg Bevacizumab administered intravenously on day 1 of each cycle, with 1 dosing cycle every 3 weeks. Docetaxel: 60-75 mg/m2 Docetaxel is given on days 1 of each cycle by intravenous infusion for 1 dosing cycle every 3 weeks.

Primary Outcome Measure

6-month PFS rate [ Time Frame: 6 months ]

Central Contacts

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