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

NCT ID: NCT04310943

Last Updated: 2024-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2023-12-01

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.

Conditions

Lung Adenocarcinoma Stage IV

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

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.

Group Type: EXPERIMENTAL

Tislelizumab

Intervention Type: DRUG

Tislelizumab, 200mg, Q3W ,use until disease progression

Interventions

Tislelizumab

Tislelizumab, 200mg, Q3W ,use until disease progression

Intervention Type: DRUG

Other Intervention Names

Albumin paclitaxel; Bevacizumab

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhou Chengzhi

OTHER

Sponsor Role: lead

Responsible Party

Zhou Chengzhi

Chief Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Zhou Chengzhi

Guangzhou, Guangdong, China

Countries

China

References

Zitvogel L, Galluzzi L, Smyth MJ, Kroemer G. Mechanism of action of conventional and targeted anticancer therapies: reinstating immunosurveillance. Immunity. 2013 Jul 25;39(1):74-88. doi: 10.1016/j.immuni.2013.06.014.

Reference Type: BACKGROUND

PMID: 23890065 (View on PubMed)

Wallin JJ, Bendell JC, Funke R, Sznol M, Korski K, Jones S, Hernandez G, Mier J, He X, Hodi FS, Denker M, Leveque V, Canamero M, Babitski G, Koeppen H, Ziai J, Sharma N, Gaire F, Chen DS, Waterkamp D, Hegde PS, McDermott DF. Atezolizumab in combination with bevacizumab enhances antigen-specific T-cell migration in metastatic renal cell carcinoma. Nat Commun. 2016 Aug 30;7:12624. doi: 10.1038/ncomms12624.

Reference Type: BACKGROUND

PMID: 27571927 (View on PubMed)

Other Identifiers

CROC2003

Identifier Type: -

Identifier Source: org_study_id