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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Lung Neoplasms

Intervention / Treatment
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* Drug: Docetaxel
* Drug: Cisplatin
* Other: Best supportive care (BSC)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Histologic or cytologic diagnosis of advanced non-small-cell lung cancer (NSCLC) Based on International Association for the Study of Lung Cancer (IASLC) 2009 new Tumor-Node-Metastasis (TNM) stage criteria of lung cancer, local advanced stage IIIB (not applicable for radical radiation therapy) disease or metastatic stage IV disease or recurrent disease At least one evaluable tumor lesion based on RECIST criteria (>= 20 mm with conventional techniques or >= 10 mm with spiral Computed Tomography scan) Eastern Cooperative Oncology Group performance status (ECOG PS) 0/1 Adequate bone marrow reserve absolute neutrophil count >= 2.0×10^9/L platelets >= 100×10^9/L hemoglobin >= 9.0 g/dL Adequate hepatic function total bilirubin <= Upper Normal Limit (UNL) Aspartate Amino Transferase (AST), Alanine Amino Transferase (ALT) <= 2.5 UNL alkaline phosphatase (ALP) <= 5 UNL Adequate renal function (serum creatinine <= UNL or creatinine clearance >= 60 mL/min) No prior chemotherapy was allowed or only (neo) adjuvant chemotherapy ended more than 6 months before treatment (patients should not have been heavily pre-treated, the maximum cumulative dose of cisplatin allowed is 350 mg/m²) Prior surgery was permitted only if the operation performed more than 4 weeks ago and the patient was completely recovery Childbearing potential either terminated or attenuated by the use of an approved contraceptive method Inform consent signed Exclusion criteria: Other tumour type than advanced / metastatic NSCLC in recent 5 years (except cone-biopsied carcinoma-in-situ of the cervix or adequately treated basal or squamous cell carcinoma of the skin). Presence of symptomatic central nervous system metastases Inadequate liver function total bilirubin > 1 UNL ALT and/or AST>1.5 UNL associated with alkaline phosphatase > 2.5 UNL inadequate renal function (creatinine > 1.0 times UNL and in case of limit value, creatinine clearance < 60 mL/min) Prior radiation therapy, or surgery operation within 4 weeks Prior use of taxoids Active infection, or serious concomitant systemic disorder incompatible with the study Childbearing potential but unwilling to use of an approved contraceptive method Receive treatment from other clinical trials during this study treatment History of hypersensitivity to any of study medication Other serious concomitant abnormal or illness The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: First line treatment: docetaxel 75 mg/m² + cisplatin 75 mg/m²<br>Docetaxel 75 mg/m² + cisplatin 75 mg/m² on day 1, repeated every 3 weeks, up to 4 cycles | Drug: Docetaxel<br>* Formulation: concentrated solution for intravenous infusion (IV) Route(s) of administration: 1-hour IV<br>* Other names: Taxotere®;Drug: Cisplatin<br>* Formulation: concentrated solution for intravenous infusion (IV) Route(s) of administration: 1-3-hour IV<br>|
| Experimental: First line treatment:: docetaxel 60 mg/m² + cisplatin 75 mg/m²<br>Docetaxel 60 mg/m² + cisplatin 75 mg/m² on day 1, repeated every 3 weeks, up to 4 cycles | Drug: Docetaxel<br>* Formulation: concentrated solution for intravenous infusion (IV) Route(s) of administration: 1-hour IV<br>* Other names: Taxotere®;Drug: Cisplatin<br>* Formulation: concentrated solution for intravenous infusion (IV) Route(s) of administration: 1-3-hour IV<br>|
| Experimental: Maintenance treatment: docetaxel (60 mg/m2)<br>Docetaxel 60 mg/m² on day 1, repeated every 3 weeks until progressive disease or up to 6 cycles | Drug: Docetaxel<br>* Formulation: concentrated solution for intravenous infusion (IV) Route(s) of administration: 1-hour IV<br>* Other names: Taxotere®;|
| Active Comparator: Maintenance treatment: best supportive care (BSC)<br>BSC until progressive disease | Other: Best supportive care (BSC)<br>* Any treatment including palliative radiotherapy for pain relief-but not chemotherapy - that is considered appropriate by the investigator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) during the maintenance treatment phase |  | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| Time to disease progression (TTP) during the maintenance treatment phase |  | From 2nd randomization up to disease progression (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) |