NCT05738317

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Xiaorong Dong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The study consisted of a screening period (no more than 4 weeks after patients signed informed consent until enrollment, with imaging assessments allowed to be archived within 4 weeks prior to enrollment), a treatment period (treatment termination defined as discontinuation of treatment for any reason, or withdrawal from the study for any reason), a safety follow-up period, and a survival follow-up period. Screening period: Patients were required to undergo a screening evaluation to determine their eligibility for the study within 4 weeks prior to enrollment. Patients eligible for the study receive adebrelimab, 20 mg/kg, Intravenous infusion, Q3W + bevacizumab, 7.5 mg/kg, Intravenous infusion, Q3W + albumin paclitaxel 100 mg/m2, D1, 8, 15, Intravenous infusion, Q3W. albumin paclitaxel treatment for 4 cycles, adebrelimab, bevacizumab use to PD, intolerable toxicity, patient withdrawal of informed consent, investigator decision to discontinue study treatment. Treatment period: Patients eligible for study enrollment were given medication sequentially on day 1 of each cycle, with a dosing window of ±5 days, and patients were required to complete various examinations including vital signs, height and weight, physical examination, laboratory tests, and physical status scores to assess tolerance for continued treatment. The specific examinations and requirements for each visit are shown in the study flow chart. End of treatment: End of treatment is defined as confirmation of disease progression or withdrawal from the study and requires an end-of-treatment visit ±5 days from the time of the decision to discontinue treatment and/or withdraw from the study. Safety follow-up. Safety follow-up visits will be conducted within 30±7, 60±7 days, and 90±7 days after the last dose. Survival follow-up. Survival follow-up will be conducted every 3 months after safety follow-up and telephone follow-up is acceptable.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Adebrelimab Combined With Bevacizumab and Albumin Paclitaxel	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.

Timeline

• Start date: 2022-12-01
• Primary completion: 2023-06-01
• Completion: 2024-12-01
• First posted: 2023-02-22
• Last updated: 2023-02-22

Locations

1 site across 1 country: China