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

Lung Adenocarcinoma Stage IV Clinical Trial

Official title:

Tislelizumab Combined With Bevacizumab and Albumin Paclitaxel in the Treatment of Advanced Lung Adenocarcinoma: a Single-arm, Phase Ⅱ Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04310943
• Other study ID #: CROC2003
• Status: Completed
• Phase: Phase 2
• Start date: March 1, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: March 2024
• Source: Guangzhou Institute of Respiratory Disease
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• lung adenocarcinoma stage ?(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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Lung
• Lung Adenocarcinoma Stage IV

Intervention

Drug:
• Tislelizumab
Tislelizumab, 200mg, Q3W ,use until disease progression

Locations

Country	Name	City	State
China	Zhou Chengzhi	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhou Chengzhi

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6m-PFS%	The proportion of 6 months progression free survival	through study completion, an average of 1 year
Primary	Safety of Tislelizumab	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)	30 days after the trial finished
Secondary	ORR	objective response rate	one year
Secondary	OS rate	rate of oversurvival rate	one year