Clinical trial · Interventional
Nab-Paclitaxel Treatment in Advanced Squamous Cell Carcinoma of Lung
A Randomized Phase II Clinical Trial of Nab-Paclitaxel and Carboplatin Compared With Gemcitabine and Carboplatin as First-line Therapy in Advanced Squamous Cell Carcinoma of Lung
NCT01236716CI-TRIAL-00015324C-TONG1002completedPhase 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)
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.
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 |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Albumin paclitaxel plus carboplatin | Drug | — | UNRESOLVED |
| Gemcitabine plus carboplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Albumin paclitaxel plus carboplatin
- description
- Treatment of Albumin paclitaxel plus carboplatin
- interventionNames
- Drug: Albumin paclitaxel plus carboplatin
- type
- ACTIVE_COMPARATOR
- label
- Gemcitabine plus carboplatin
- description
- Treatment of Gemcitabine plus carboplatin
- interventionNames
- Drug: Gemcitabine plus carboplatin
Primary outcomes (1)
- measure
- Overall response rate(ORR)
- timeFrame
- 18weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Previously untreated, histological documented stage IIIB (not amenable for radical regional therapy) or stage IV squamous cell carcinoma of lung. At least one measurable lesion as defined by RECIST criteria. * At least 18 years of age. * ECOG PS 0\~1 * Patients have no previously malignant tumor history except cured cervical carcinoma in situ, basal cell carcinoma or superficial bladder cancer. Patients are also eligible if they have received a chemotherapy regimen as neoadjuvant or adjuvant chemotherapy and the disease recurred over 12 months since the finishing of neoadjuvant or adjuvant chemotherapy. * neutrophil ≥ 1.5 x 109 /L, Hemoglobin \> 90 g/L, Platelet count \> 100x109/L. * Total bilirubin ≤ 1.5 x upper limit of normal. ALT and AST \< 2.5 x upper limit of normal without liver metastasis, ALT and AST \< 5 x upper limit of normal with liver metastasis. Serum creatinine \< 1.5 x upper limit of normal. * Urine pregnancy test is negative for woman. * Estimated life expectancy is at least 3 months. * Patient comply with the clinical trial protocal. * Informed consent must be signed. Exclusion Criteria: * Patients who are currently undergoing other anti-tumor therapy. * Patients who was enrolled in any other clinical trial within 4 weeks of study entry. * Any physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of any study medication or render the subject at high risk from treatment. * Central nervous system (CNS) tumor or metastatic tumor. * Serious mental disorder. * Serious dysgnosia. * Other serious comorbidity. * Alcohol or drug dependence. * Previously allergic to drugs used in the study.
References
Publications (3)
- DERIVEDWang 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. PMID 30739019
- DERIVEDYang 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. PMID 25239521
- DERIVEDGold 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. PMID 22461458