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

NCT04310943 | Completed Phase 2

• 1 other identifier: CROC2003
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Adenocarcinoma Stage IV

Outcome Measures

Primary Outcomes (2)

• 6m-PFS%

  The proportion of 6 months progression free survival

  through study completion, an average of 1 year

• 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 Outcomes (2)

• ORR

  one year

• OS rate

  one year

Study Arms (1)

Arm 1

EXPERIMENTAL

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.

Drug: Tislelizumab

Interventions

Tislelizumab DRUG

Tislelizumab, 200mg, Q3W ,use until disease progression

Also known as: Albumin paclitaxel, Bevacizumab

Arm 1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhou Chengzhi: lead

Study Sites (1)

Zhou Chengzhi

Guangzhou, Guangdong, 510120, China

Location

Related Publications (2)

• 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.

  PMID: 23890065 BACKGROUND

• 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.

  PMID: 27571927 BACKGROUND

MeSH Terms

Conditions

Adenocarcinoma of Lung

Interventions

tislelizumab; Bevacizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: March 13, 2020
• First Posted: March 17, 2020
• Study Start: March 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)