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

• ClinicalTrials.gov Identifier: NCT01038661
• Recruitment Status: Completed
• First Posted: December 24, 2009
• Last Update Posted: February 28, 2014
• Sponsor: Sanofi
• Information provided by (Responsible Party): Sanofi

Tracking Information

• First Submitted Date: December 22, 2009
• First Posted Date: December 24, 2009
• Last Update Posted Date: February 28, 2014
• Study Start Date: November 2009
• Actual Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 27, 2014): 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) ]
• Original Primary Outcome Measures (submitted: December 22, 2009): Progression-free survival [ Time Frame: From randomization to any progression event or patient death for any cause (every 2 cycles during study treatment, and then every 8 weeks during follow-up period) ]

Current Secondary Outcome Measures (submitted: February 27, 2014)

• Disease control rate (DCR) during the first line treatment phase [ Time Frame: Every 2 cycles (6 weeks) ]
• Overall response rate (ORR) during the first line treatment phase [ Time Frame: Every 2 cycles (6 weeks) ]
• Time to disease progression (TTP) during the maintenance treatment phase [ Time Frame: From 2nd randomization up to disease progression (every 2 cycles (6 weeks)) ]
• Overall survival (OS) [ Time Frame: 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) ]

Original Secondary Outcome Measures (submitted: December 22, 2009)

• Disease control rate [ Time Frame: Assessment during study treatment completed at every 2 cycles (6 weeks) ]
• Overall response rate [ Time Frame: Assessment during study treatment completed at every 2 cycles (6 weeks) ]
• Time to disease progression (TTP) [ Time Frame: From randomization to progressive disease is objectively documented (assessment during study treatment completed at every 2 cycles (6weeks) ) ]
• Overall survival [ Time Frame: From randomization to patient death for any cause (every 2 cycles (6weeks) during study treatment, and then every 8 weeks during follow-up period) ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Tax First-line Chemotherapy With Different Doses and Then Maintenance Therapy
• Official Title: 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

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.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Lung Neoplasms

Intervention

• Drug: Docetaxel

  Formulation: concentrated solution for intravenous infusion (IV)

  Route(s) of administration: 1-hour IV

  Other Name: Taxotere®
• 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

Study Arms

• Experimental: 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
  Interventions:

  • Drug: Docetaxel
  • Drug: Cisplatin
• Experimental: 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
  Interventions:

  • Drug: Docetaxel
  • Drug: Cisplatin
• Experimental: 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: Drug: Docetaxel
• Active Comparator: Maintenance treatment: best supportive care (BSC)
  BSC until progressive disease
  Intervention: Other: Best supportive care (BSC)

• Publications *: Zhang L, Lu S, Cheng Y, Hu Z, Wu YL, Chen Z, Chen G, Liu X, Yang J, Zhang L, Chen J, Huang M, Tao M, Cheng G, Huang C, Zhou C, Zhang W, Zhao H, Sun Y. Docetaxel maintenance therapy versus best supportive care after first-line chemotherapy with different dose docetaxel plus cisplatin for advanced non-small cell lung cancer (TFINE study, CTONG-0904): an open-label, randomized, phase III trial. Ann Transl Med. 2021 Feb;9(4):338. doi: 10.21037/atm-20-8078.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 27, 2014): 375
• Original Estimated Enrollment (submitted: December 22, 2009): 380
• Actual Study Completion Date: August 2012
• Actual Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT01038661
• Other Study ID Numbers: DOCET_L_04827
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Sanofi
• Original Responsible Party: Medical Affairs Study Director, sanofi-aventis
• Current Study Sponsor: Sanofi
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Clinical Sciences & Operations; Sanofi

• PRS Account: Sanofi
• Verification Date: February 2014