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Completed

NCT Number: NCT04310943

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

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.

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Key information

Conditions

Lung Adenocarcinoma Stage IV Adenocarcinoma Adenocarcinoma of Lung Carcinoma Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Zhou Chengzhi

Guangzhou, Guangdong, 510120, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tislelizumab

Drug

Tislelizumab, 200mg, Q3W ,use until disease progression

Other names: Albumin paclitaxel, Bevacizumab

Primary outcomes

  1. 6m-PFS%

    Time frame: through study completion, an average of 1 year

    The proportion of 6 months progression free survival

  2. Safety of Tislelizumab

    Time frame: 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 outcomes

  1. ORR

    Time frame: one year

    objective response rate

  2. OS rate

    Time frame: one year

    rate of oversurvival rate

Sponsors and collaborators

Lead sponsor

Zhou Chengzhi

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 17, 2020
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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