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
Overview
- Phase
- Phase 3
- Intervention
- Docetaxel
- Conditions
- Lung Neoplasms
- Sponsor
- Sanofi
- Enrollment
- 375
- Locations
- 1
- Primary Endpoint
- Progression-free survival (PFS) during the maintenance treatment phase
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
First line treatment: docetaxel 75 mg/m² + cisplatin 75 mg/m²
Docetaxel 75 mg/m² + cisplatin 75 mg/m² on day 1, repeated every 3 weeks, up to 4 cycles
Intervention: Docetaxel
First line treatment: docetaxel 75 mg/m² + cisplatin 75 mg/m²
Docetaxel 75 mg/m² + cisplatin 75 mg/m² on day 1, repeated every 3 weeks, up to 4 cycles
Intervention: Cisplatin
First line treatment:: docetaxel 60 mg/m² + cisplatin 75 mg/m²
Docetaxel 60 mg/m² + cisplatin 75 mg/m² on day 1, repeated every 3 weeks, up to 4 cycles
Intervention: Docetaxel
First line treatment:: docetaxel 60 mg/m² + cisplatin 75 mg/m²
Docetaxel 60 mg/m² + cisplatin 75 mg/m² on day 1, repeated every 3 weeks, up to 4 cycles
Intervention: Cisplatin
Maintenance treatment: docetaxel (60 mg/m2)
Docetaxel 60 mg/m² on day 1, repeated every 3 weeks until progressive disease or up to 6 cycles
Intervention: Docetaxel
Maintenance treatment: best supportive care (BSC)
BSC until progressive disease
Intervention: Best supportive care (BSC)
Outcomes
Primary Outcomes
Progression-free survival (PFS) during the maintenance treatment phase
Time Frame: From 2nd randomization to progression or death of any cause (every 2 cycles (6 weeks) during study treatment, and then every 8 weeks during follow-up period)
Secondary Outcomes
- Time to disease progression (TTP) during the maintenance treatment phase(From 2nd randomization up to disease progression (every 2 cycles (6 weeks)))
- Disease control rate (DCR) during the first line treatment phase(Every 2 cycles (6 weeks))
- Overall response rate (ORR) during the first line treatment phase(Every 2 cycles (6 weeks))
- Overall survival (OS)(From 1st randomization to death of any cause (every 2 cycles (6 weeks) during study treatment, and then every 8 weeks during follow-up period))