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Report for Clinical Trial NCT04310943

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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 one-year PFS rate and safety, the seconday endpoint is ORR and one-year OS rate.

NCT04310943 Lung Adenocarcinoma Stage IV
MeSH:Adenocarcinoma Aden Adenocarcinoma of Lung

1 Interventions

Name: Tislelizumab

Description: Tislelizumab, 200mg, Q3W ,use until disease progression
Type: Drug
Group Labels: 1

Arm 1


Primary Outcomes

Description: rate of progression free survical in one year

Measure: PFS rate

Time: one year

Description: 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)

Measure: Safety of Tislelizumab

Time: 30 days after the trial finished

Secondary Outcomes

Description: objective response rate

Measure: ORR

Time: one year

Description: rate of oversurvival rate

Measure: OS rate

Time: one year

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 T790M

Inclusion Criteria: - lung adenocarcinoma stage Ⅳ(according AJCC 8) - received EGFR-TKI for 1 line and disease progression - EGFR T790M negative - ECOG PS 0-1 Exclusion Criteria: - histology of mixed NSCLC with squamous cell carcinoma, neuroendocrine carcinoma and small cell carcinoma. --- T790M ---

- 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 Inclusion Criteria: - lung adenocarcinoma stage Ⅳ(according AJCC 8) - received EGFR-TKI for 1 line and disease progression - EGFR T790M negative - ECOG PS 0-1 Exclusion Criteria: - histology of mixed NSCLC with squamous cell carcinoma, neuroendocrine carcinoma and small cell carcinoma. --- T790M ---



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