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

Zhou Chengzhi

Status and phase: Completed; Phase 2

Conditions: Lung Adenocarcinoma Stage IV

Treatments: Drug: Tislelizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT04310943

CROC2003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Arm 1

Experimental group

Description:

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.

Treatment:

Drug: Tislelizumab