Lung Neoplasms
Conditions
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.
Interventions
DRUGDocetaxel
Formulation: concentrated solution for intravenous infusion (IV) Route(s) of administration: 1-hour IV
DRUGCisplatin
Formulation: concentrated solution for intravenous infusion (IV) Route(s) of administration: 1-3-hour IV
OTHERBest supportive care (BSC)
Any treatment including palliative radiotherapy for pain relief-but not chemotherapy - that is considered appropriate by the investigator
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | 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) |
Countries
China
Outcome results
None listed