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This is a randomized, multicenter, open, controlled phase III trial. 388 subjects with stage IIIB who were not eligible for radical surgery or radiotherapy, stage IV or recurrent squamous cell NSCLC were enrolled in this study .The subjects will be randomly assigned to one of the two treatment groups at a 1: 1 ratio, and stratified by sex, ECOG physical status, smoking status, disease staging.
Subjects will receive one of two treatment regimens:
Group A: intravenous infusion of paclitaxel (albumin binding) 260 mg/m2, intravenous infusion, carboplatin area under curve (AUC) = 6, intravenous infusion, starting from randomization, once every 3 weeks, for 4-6 cycles,or progression, or intolerance, or deth or start a new anti-tumor treatment, whichever occurs first.
Group B: paclitaxel injection 175 mg/m2, intravenous infusion, carboplatin AUC= 6, intravenous infusion, starting from randomization, once every 3 weeks, for 4-6 cycles, or progression, or intolerance,or death or start a new anti-tumor treatment, whichever occurs first.The primary end point is overall response rate (ORR),the secondary endpoint is progression-free survival (PFS), overall survival (OS), safety and Quality of Life (QOL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nab-paclitaxel plus carboplatin | Experimental | nab-paclitaxel 260mg/m2,i.v., plus carboplatin AUC = 6,i.v., starting from randomization, once every 3 weeks, for 4-6 cycles, or progression, or intolerance,or death or start a new anti-tumor treatment, whichever occurs first. |
|
| Paclitaxel plus carboplatin | Active Comparator | paclitaxel 175 mg/m2,i.v., plus carboplatin AUC = 6,i.v., starting from randomization, once every 3 weeks, for 4-6 cycles, or progression, or intolerance,or death or start a new anti-tumor treatment, whichever occurs first. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nab-paclitaxel | Drug | albumin-bound paclitaxel is 260 mg/m2 intravenously over 30 minutes on Days 1 of each 21-day cycle cycle immediately after albumin-bound paclitaxel |
|
| Measure | Description | Time Frame |
|---|---|---|
| overall respond rate | the rate of CR and PR | overall respond rate will be evaluated every 6 weeks until progression or new anti-cancer therapy initiation, up to 22 months. |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | progression free survival | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months |
| os | overall survival |
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Inclusion Criteria:
Exclusion Criteria:
I) total bilirubin (TBil) level:> normal upper limit (ULN) 1.5 times; II) 2.5 times the rate of aspartate aminotransferase (AST) and alanine aminotransferase (ALT)> ULN, and> 5 times ULN if liver metastases are present
Serum creatinine> ULN 1.5 times, or creatinine clearance <50ml/min
International Standardization Ratio (INR)> 1.5 times the ULN, and prothrombin time (PT) or activated partial coagulation Blood enzyme time (aPTT)> ULN 1.5 times, unless the subject is receiving anticoagulant therapy
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| yumei wang, docter | Contact | +86 0311-67808816 | wyumei73@mail.ecspc.com |
| Name | Affiliation | Role |
|---|---|---|
| li zhang, doctor | Sun Yat-Sen University Cancer Center | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22547591 | Result | Socinski MA, Bondarenko I, Karaseva NA, Makhson AM, Vynnychenko I, Okamoto I, Hon JK, Hirsh V, Bhar P, Zhang H, Iglesias JL, Renschler MF. Weekly nab-paclitaxel in combination with carboplatin versus solvent-based paclitaxel plus carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer: final results of a phase III trial. J Clin Oncol. 2012 Jun 10;30(17):2055-62. doi: 10.1200/JCO.2011.39.5848. Epub 2012 Apr 30. |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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|
| Paclitaxel | Drug | paclitaxel is 175 mg/m2 intravenously over 3 hours on Days 1 of each 21-day cycle cycle immediately after paclitaxel |
|
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| Carboplatin | Drug | carboplatin is administered on Day 1 of each 21-day,followed by paclitaxel or nab-paclitaxel |
|
|
| From date of randomization until the date of death from any cause,assessed up to 18 months |
| Quality of life assessment | evaluate the QOL according to Functional Assessment of Cancer Therapy-lung (FACT-L) | It will be assessed before the administration of drugs at each first day of the chemotherapy cycle,up to 6 cycles,each cycle is 21 days. |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |