drugset / Trial / NCT01236716
Nab-Paclitaxel Treatment in Advanced Squamous Cell Carcinoma of Lung
RandomizedParallel-groupOpen-labelTreatment
Summary
This trial is to study the efficacy of nab-PC vs. GC and evaluate toxicity of nab-PC in advanced squamous cell cancer of lung. The correlation between the efficacy of nab-PC and some biomarkers is also to be evaluated.
Timeline
- Start
- 2010-11
- Primary completion
- 2013-12
- Completion
- 2014-06
Outcome
Missed primary endpoint
paper Nab-PC has higher ORR than GC without statistical significance (42% versus 27%, P > 0.05). PMID 30739019 ↗
Publications
- Wang Z, Huang C, Yang JJ, Song Y, Cheng Y, Chen GY, Yan HH, Ben XS, Wang BC, Xu CR, Jiang BY, Zhou Q, Chen HJ, Wu YL. A randomised phase II clinical trial of nab-paclitaxel and carboplatin compared with gemcitabine and carboplatin as first-line therapy in advanced squamous cell lung carcinoma (C-TONG1002). Eur J Cancer. 2019 Mar;109:183-191. doi: 10.1016/j.ejca.2019.01.007. Epub 2019 Feb 7.
- Yang JJ, Huang C, Chen GY, Song Y, Cheng Y, Yan HH, Zhou Q, Wu YL. A randomized phase II clinical trial of nab-paclitaxel and carboplatin compared with gemcitabine and carboplatin as first-line therapy in locally advanced or metastatic squamous cell carcinoma of lung. BMC Cancer. 2014 Sep 20;14:684. doi: 10.1186/1471-2407-14-684.
- Gold KA, Wistuba II, Kim ES. New strategies in squamous cell carcinoma of the lung: identification of tumor drivers to personalize therapy. Clin Cancer Res. 2012 Jun 1;18(11):3002-7. doi: 10.1158/1078-0432.CCR-11-2055. Epub 2012 Mar 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Gemcitabine | Small molecule | 1250 mg/m2 | — |
| Subject | Paclitaxel | Small molecule | 135 mg/m2 | — |
| Comparator | Carboplatin | Small molecule | — | — |