NCT01038661

Tax First-line Chemotherapy With Different Doses and Then Maintenance Therapy

Randomized, Controlled Study Comparing the Efficacy and Safety of Docetaxel （60mg/m2）Maintenance Treatment vs. Best Supportive Care Following First Line Chemotherapy With Different Doses of Docetaxel（75/60mg/m2）in Combination With Cisplatin in Patients With Local Advanced or Metastatic （Stage IIIB/IV）Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 375 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The Primary Objective is to evaluate the progression-free survival (PFS). The secondary objectives are: * To compare the disease control rates of different doses of Docetaxel+Cisplatin as first-line treatment according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria; * To evaluate the overall response rate (ORR); * To evaluate the time to disease progression (TTP); * To evaluate the overall survival (OS); * To evaluate the toxicity.

Detailed description

The study consists in: * A first line treatment phase: participants receive 4 cycles of chemotherapy (each cycle contains 3 weeks) with either docetaxel (75 mg/m2) plus cisplatin (75 mg/m2) or docetaxel (60 mg/m2) plus cisplatin (75 mg/m2) , * A maintenance treatment phase: participants with disease control (complete response \[CR\], partial response \[PR\] or stable disease \[SD\]) after the initial treatment receive up to 6 cycles of chemotherapy with docetaxel (60 mg/m2) or best supportive care (BSC). * A follow-up period from the end of study treatment until participant death or end of study.

Conditions

• Lung Neoplasms

Interventions

Type	Name	Description
DRUG	Docetaxel	Formulation: concentrated solution for intravenous infusion (IV) Route(s) of administration: 1-hour IV
DRUG	Cisplatin	Formulation: concentrated solution for intravenous infusion (IV) Route(s) of administration: 1-3-hour IV
OTHER	Best supportive care (BSC)	Any treatment including palliative radiotherapy for pain relief-but not chemotherapy - that is considered appropriate by the investigator

Timeline

• Start date: 2009-11-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2009-12-24
• Last updated: 2014-02-28

Locations

1 site across 1 country: China