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

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Status and phase

Phase 3


Lung Neoplasms


Drug: Docetaxel
Drug: Cisplatin
Other: Best supportive care (BSC)

Study type


Funder types




Details and patient eligibility


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.

Full 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.


375 patients




18 to 75 years old


No Healthy Volunteers

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.

Trial design

Primary purpose




Interventional model

Parallel Assignment


None (Open label)

375 participants in 4 patient groups

First line treatment: docetaxel 75 mg/m² + cisplatin 75 mg/m²
Experimental group
Docetaxel 75 mg/m² + cisplatin 75 mg/m² on day 1, repeated every 3 weeks, up to 4 cycles
Drug: Cisplatin
Drug: Docetaxel
First line treatment:: docetaxel 60 mg/m² + cisplatin 75 mg/m²
Experimental group
Docetaxel 60 mg/m² + cisplatin 75 mg/m² on day 1, repeated every 3 weeks, up to 4 cycles
Drug: Cisplatin
Drug: Docetaxel
Maintenance treatment: docetaxel (60 mg/m2)
Experimental group
Docetaxel 60 mg/m² on day 1, repeated every 3 weeks until progressive disease or up to 6 cycles
Drug: Docetaxel
Maintenance treatment: best supportive care (BSC)
Active Comparator group
BSC until progressive disease
Other: Best supportive care (BSC)

Trial contacts and locations



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