Efficacy and Safety of Tislelizumab Combined With Bevacizumab and Albumin Paclitaxel in Lung Adenocarcinoma

Phase 2

Completed

• Conditions: Lung Adenocarcinoma Stage IV
• Interventions: Drug: Tislelizumab

• Registration Number: NCT04310943
• Lead Sponsor: Zhou Chengzhi

Brief Summary

The single arm clinical study is to evaluate the efficacy and safety of Tislelizumab combined with Bevacizumab and albumin paclitaxel in the treatment of advanced lung adenocarcinoma. All of the patients were received EGFR-TKI therapy for 1 line and disease progression. The primary endpoint is six months PFS and safety, the seconday endpoint is ORR and one-year OS rate.

Detailed Description

Patients who meet the inclusion criteria will receive Tislelizumab combined with Bevacizumab and albumin paclitaxel for 4 cycles. If there is no disease progression, the patient will continue to receive Tislelizumab maintenance therapy, until the disease progresses or death.

Study Timeline

• Study First Submitted: 2020-03-13
• Study First Submitted QC: 2020-03-16
• Study First Posted: 2020-03-17
• Study Start: 2021-03-01
• Primary Completion: 2023-06-01
• Study Completion: 2023-12-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• lung adenocarcinoma stage Ⅳ(according AJCC 8)
• received EGFR-TKI for 1 line and disease progression
• EGFR T790M negative
• ECOG PS 0-2

Exclusion Criteria

• histology of mixed NSCLC with squamous cell carcinoma, neuroendocrine carcinoma and small cell carcinoma.
• have received checkpoint inhibitor.
• uncontrolled pleural effusion, pericardial effusion, or ascites after appropriate intervention
• any unstable systemic disease
• patients who were treated with systemic glucocorticoids (>10mg/ day prednisone therapeutic dose) or other immunosuppressive drugs within 14 days prior to the initial administration or during the study period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Tislelizumab	Tislelizumab (200mg,Q3W )+Bevacizumab(15 mg/kg,Q3W)+Albumin paclitaxel(100mg/m2,d1,8,15) for 4 cycles, and if there is no disease progression, patients will receive Tislelizumab(200mg,Q3W) until progression or death.

Primary Outcome Measures

Name	Time	Method
6m-PFS%	through study completion, an average of 1 year	The proportion of 6 months progression free survival
Safety of Tislelizumab	30 days after the trial finished	TEAE are adverse events that occur during or after the first administration of the study drug until 30 days after the study drug is discontinued or the new anticancer treatment is initiated or worse than at baseline (before treatment)

Secondary Outcome Measures

Name	Time	Method
OS rate	one year	rate of oversurvival rate
ORR	one year	objective response rate

Trial Locations

Locations (1)

Zhou Chengzhi; 🇨🇳 Guangzhou, Guangdong, China