Efficacy and Safety of Tislelizumab Combined With Bevacizumab and Albumin Paclitaxel in Lung Adenocarcinoma
Study Details
Study Description
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 one-year PFS rate and safety, the seconday endpoint is ORR and one-year OS rate.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm 1 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
Tislelizumab, 200mg, Q3W ,use until disease progression
Other Names:
|
Outcome Measures
Primary Outcome Measures
- PFS rate [one year]
rate of progression free survical in one year
- 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 Outcome Measures
- ORR [one year]
objective response rate
- OS rate [one year]
rate of oversurvival rate
Eligibility Criteria
Criteria
Inclusion Criteria:
-
lung adenocarcinoma stage Ⅳ(according AJCC 8)
-
received EGFR-TKI for 1 line and disease progression
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EGFR T790M negative
-
ECOG PS 0-1
Exclusion Criteria:
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histology of mixed NSCLC with squamous cell carcinoma, neuroendocrine carcinoma and small cell carcinoma.
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have received checkpoint inhibitor.
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uncontrolled pleural effusion, pericardial effusion, or ascites after appropriate intervention
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any unstable systemic disease
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhou Chengzhi | Guangzhou | Guangdong | China | 510120 |
Sponsors and Collaborators
- Zhou Chengzhi
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Wallin JJ, Bendell JC, Funke R, Sznol M, Korski K, Jones S, Hernandez G, Mier J, He X, Hodi FS, Denker M, Leveque V, Cañamero 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.
- 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. Review.
- CROC2003