Clinical trial · Interventional
Efficacy and Safety of Tislelizumab Combined With Bevacizumab and Albumin Paclitaxel in Lung Adenocarcinoma
Tislelizumab Combined With Bevacizumab and Albumin Paclitaxel in the Treatment of Advanced Lung Adenocarcinoma: a Single-arm, Phase Ⅱ Clinical Trial
NCT04310943CI-TRIAL-00074705completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Adenocarcinoma Stage IV | Lung Adenocarcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tislelizumab | Drug | Tislelizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- 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.
- interventionNames
- Drug: Tislelizumab
Primary outcomes (2)
- measure
- 6m-PFS%
- timeFrame
- through study completion, an average of 1 year
- description
- The proportion of 6 months progression free survival
- measure
- Safety of Tislelizumab
- timeFrame
- 30 days after the trial finished
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDZitvogel 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
- BACKGROUNDWallin 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