Lung Adenocarcinoma Stage IV
Conditions
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.
Interventions
DRUGTislelizumab
Tislelizumab, 200mg, Q3W ,use until disease progression
Sponsors
Zhou Chengzhi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6m-PFS% | through study completion, an average of 1 year | The proportion of 6 months progression free survival |
| Safety of Tislelizumab | 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
| Measure | Time frame | Description |
|---|---|---|
| ORR | one year | objective response rate |
| OS rate | one year | rate of oversurvival rate |
Countries
China
Outcome results
None listed