Neo-adjuvant Treatment in Non-Small Cell Lung Cancer (NSCLC)
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different
      ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
      help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as
      cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by
      killing the cells or by stopping them from dividing. Radiation therapy uses high-energy
      x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of
      radiation directly to the tumor may kill more tumor cells and cause less damage to normal
      tissue. Giving these treatments before surgery may make the tumor smaller and reduce the
      amount of normal tissue that needs to be removed.

      PURPOSE: This phase II trial is studying the side effects of giving cetuximab together with
      cisplatin and docetaxel before radiation therapy and cetuximab followed by surgery and to see
      how well it works in treating patients with stage IIIB non-small cell lung cancer that can be
      removed by surgery.
    

Detailed description: 
      OBJECTIVES:

        -  To evaluate the efficacy and safety of neoadjuvant sequential chemoimmunotherapy
           comprising cetuximab, cisplatin, and docetaxel before radiotherapy and cetuximab
           followed by surgery in patients with resectable stage IIIB non-small cell lung cancer.

      OUTLINE: This is a multicenter study.

        -  Chemoimmunotherapy (courses 1-3): Patients receive chemoimmunotherapy comprising
           cetuximab IV over 1-2 hours on days 1, 8, and 15; cisplatin IV over 1 hour on days 1 and
           2; and docetaxel IV over 1 hour on day 1. Patients also receive filgrastim (G-CSF) on
           days 3-8 or a single dose of pegfilgrastim the day after chemotherapy. Treatment repeats
           every 3 weeks for 3 courses.

        -  Radiotherapy (course 4): Beginning on day 1 of week 10, patients undergo 3-dimensional
           conformal or intensity-modulated radiotherapy 5 days a week for 3 weeks. Patients also
           receive cetuximab IV over 1 hour on days 1, 8, and 15.

        -  Surgery: Beginning 21-28 days after completion of radiotherapy, patients undergo
           surgery.

      After completion of study treatment, patients are followed every 3 months for 2 years and
      every 6 months for 3 years.
    

Intervention name(s): cetuximab; cisplatin; docetaxel; Radiotherapy; Surgery
Intervention type(s): Drug; Drug; Drug; Radiation; Procedure
Intervention description(s): 400 mg/m2 initial dose on day 1 250 mg/m2 weekly starting on day 8 and for 12 weeks; 50 mg/m2 on day 1 and 2 of 21 day cycles, for 3 cycles; 85 mg/m2 day 1 of 21 day cycles, for 3 cycles; 44 Gy (PTV1=30 Gy, PTV2=14 Gy), for 3 weeks, after the 3 cycles of Cisplatin / Docetaxel treatment; Ipsilateral formal mediastinal lymphadenectomy. In case of involved N3 lymph nodes, resection of the precarinal and contralateral nodes.
Other intervention name(s): Erbitux; Platin; Taxotere
Intervention MeSH terms: Docetaxel; Cetuximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IIIB non-small cell lung cancer; adenocarcinoma of the lung; adenosquamous cell lung cancer; large cell lung cancer; squamous cell lung cancer