Adebrelimab Combined With Bevacizumab and Albumin Paclitaxel in Non-squamous NSCLC After First-line Treatment

Sponsor
Xiaorong Dong
Study ID
NCT05738317
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Adebrelimab Combined With Bevacizumab and Albumin Paclitaxel — DRUG
    Adebrelimab is recommended to be administered with an infusion pump. The infusion pipeline is equipped with a 0.22-micron online filter membrane. Intravenous injection or bolus injection is not allowed. At the end of infusion, flush the infusion tube with sufficient 5% glucose or physiological saline, and do not share the same infusion tube with other drugs. In each treatment cycle, Adebrelimab should be given intravenously first.

Study Details

A prospective, single-arm, phase II trial of Adebrelimab combined with bevacizumab and albumin paclitaxel in advanced non-squamous non-small cell lung cancer after first-line immunotherapy progression.

Key Dates

First listed
Feb 22, 2023
Start date
Dec 1, 2022
Status verified
Feb 2023
Primary completion
Jun 1, 2023
Completion
Dec 1, 2024

Study Design

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

Arms

  • Experimental: Adebrelimab Combined With Bevacizumab and Albumin Paclitaxel
    Adebrelimab: 20 mg/kg 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. Albumin Paclitaxel: 100 mg/m2 Albumin Paclitaxel is given on days 1, 8, and 15 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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