Neo-adjuvant Treatment in Non-Small Cell Lung Cancer (NSCLC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01059188
Recruitment Status : Active, not recruiting
First Posted : January 29, 2010
Last Update Posted : July 25, 2017
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research

Brief 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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: cetuximab Drug: cisplatin Drug: docetaxel Radiation: Radiotherapy Procedure: Surgery Phase 2

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preoperative Chemotherapy and Radiotherapy Concomitant to Cetuximab in Non-Small Cell Lung Cancer (NSCLC) Patients With IIIB Disease - A Multicenter Phase II Trial
Actual Study Start Date : May 3, 2010
Actual Primary Completion Date : December 9, 2016
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Cetuximab, Cisplatin, Docetaxel, Radiotherapy and Surgery Drug: cetuximab
400 mg/m2 initial dose on day 1 250 mg/m2 weekly starting on day 8 and for 12 weeks
Other Name: Erbitux
Drug: cisplatin
50 mg/m2 on day 1 and 2 of 21 day cycles, for 3 cycles
Other Name: Platin
Drug: docetaxel
85 mg/m2 day 1 of 21 day cycles, for 3 cycles
Other Name: Taxotere
Radiation: Radiotherapy
44 Gy (PTV1=30 Gy, PTV2=14 Gy), for 3 weeks, after the 3 cycles of Cisplatin / Docetaxel treatment
Procedure: Surgery
Ipsilateral formal mediastinal lymphadenectomy. In case of involved N3 lymph nodes, resection of the precarinal and contralateral nodes.

Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: at 1 year (+/- 1 month) ]

Secondary Outcome Measures :
  1. Treatment-related death during chemoimmunotherapy, radioimmunotherapy, and perioperatively [ Time Frame: 30 days after surgery ]
  2. Metabolic response evaluated by PET [ Time Frame: At baseline and after chemo-immunotherapy ]
  3. Response status after chemoimmunotherapy and radioimmunotherapy [ Time Frame: After chemoimmunotherapy and after radioimmunotherapy ]
  4. Complete pathological response [ Time Frame: After surgery ]
  5. Overall survival [ Time Frame: At the end of the follow-up phase (max. 5 years after treatment termination or surgery) ]
  6. Adverse events [ Time Frame: During the all trial treatment until 30 days after surgery or treatment stop ]
  7. Operability [ Time Frame: Before trial treatment ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed non-small cell lung cancer (NSCLC)

    • Squamous, adeno, large cell, or poorly differentiated disease
    • Stage IIIB disease (T4N0-3M0 or T1-4N3M0) according to 6th TNM classification

      • Assessed by bronchoscopy and PET-CT scan within 42 days of registration
      • No malignant pleural or pericardial effusion, invasion of the aorta, esophagus, myocardium, or supraclavicular
      • No scalene nodes N3
      • No stages IIIB disease defined only by satellite lesions in the same lobe
  • Lymph node staging done by mediastinoscopy (or EBUS) in N+ disease on PET-CT scan (SUV above mediastinum background SUV) or CT (size > 10 mm in the smallest diameter) within 42 days of registration

    • Fine needle aspiration biopsy must be done by EBUS, TBNA, or VATS if lymph nodes are not accessible by mediastinoscopy (ATS nodes #5/6)
    • Mediastinoscopy is mandatory for suspicion of T4 tumor invading the trachea on PET-CT and CT scan in N-disease
  • Measurable disease assessed by contrast-enhanced CT-scan within 28 days of registration
  • Tumor tissue available for translational research (no cytology)
  • Resectable disease based on a multidisciplinary tumor board decision
  • No brain metastasis (confirmed by MRI within 42 days of registration)


  • WHO performance status 0-1
  • Platelet count ≥ 100 x 10^9/L
  • Neutrophil count ≥ 1.5 x 10^9/L
  • Bilirubin normal
  • AST ≤ 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Creatinine clearance ≥ 60 mL/min
  • FEV1 and DLCO ≥ 80% OR exercise test peak V02 > 75% or 20 mL kg^-1 min^-1 (for pneumonectomy)
  • Exercise test peak V02 ≥ 35% and ≥ 10 mL kg^-1 min^-1 with predicted postoperative FEV1 and DLCO ≥ 30% (for resection less than pneumonectomy [resection up to calculated extend according to ESTS/ACCP guidelines])
  • Ejection fraction > 45% assessed by echocardiography
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 12 months after completion of study therapy
  • Must be compliant and geographically proximal for proper staging and follow-up
  • No previous malignancy within the past 5 years except for adequately treated carcinoma in situ of the cervix or localized nonmelanoma skin cancer
  • No psychiatric disorder precluding understanding of information on trial-related topics and giving informed consent
  • No preexisting peripheral neuropathy > grade 1
  • No ischemia or relevant dysfunction revealed by noninvasive stress testing (stress radionuclide myocardial perfusion imaging or dobutamine stress echocardiography) for patients with a history of ischemic heart disease or any other relevant cardiovascular condition
  • No unstable cardiac disease requiring treatment, congestive heart failure or angina pectoris even if medically controlled, significant arrhythmia, or myocardial infarction within the past 3 months
  • No serious underlying medical condition that, at the judgment of the investigator, could impair the ability of the patient to participate in the trial (e.g., active autoimmune disease, uncontrolled diabetes, or uncontrolled infection)
  • No known hypersensitivity to trial drugs or hypersensitivity to any other component of the trial drugs
  • No absolute contraindications for the use of corticosteroids as premedication


  • No prior radiotherapy to the chest
  • No pretreatment with any cytostatic therapy
  • No concurrent corticosteroids, except for prophylactic medication regimen prior to treatment or treatment of acute hypersensitivity reactions or chronic treatment (initiated > 6 months prior to trial entry) at low-dose (< 20 mg methylprednisolone or equivalent)
  • No concurrent drugs contraindicated for use with the trial drugs
  • At least 30 days since prior and no other concurrent experimental drugs or other anticancer therapy on another clinical trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01059188

Saint Claraspital AG
Basel, Switzerland, CH-4016
Basel, Switzerland, CH-4031
Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
Bellinzona, Switzerland, CH-6500
Inselspital Bern
Bern, Switzerland, CH-3010
Spitalzentrum Biel
Biel, Switzerland, CH-2501
Kantonsspital Bruderholz
Bruderholz, Switzerland, CH-4101
Kantonsspital Graubuenden
Chur, Switzerland, CH-7000
Hopital Fribourgeois
Fribourg, Switzerland, 1708
Hopital Cantonal Universitaire de Geneve
Geneva, Switzerland, CH-1211
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
Kantonsspital Liestal
Liestal, Switzerland, CH-4410
Kantonsspital - St. Gallen
St. Gallen, Switzerland, CH-9007
Thun, Switzerland, 3600
Kantonsspital Winterthur
Winterthur, Switzerland, CH-8400
UniversitaetsSpital Zuerich
Zurich, Switzerland, CH-8091
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Study Chair: Solange Peters, MD Centre Hospitalier Universitaire Vaudois
Study Chair: Daniel C. Betticher, MD Kantonsspital Freiburg
Study Chair: Miklos Pless, Prof Kantonsspital Winterthur KSW
Study Chair: Roger Stupp, MD Centre Hospitalier Universitaire Vaudois

Responsible Party: Swiss Group for Clinical Cancer Research Identifier: NCT01059188     History of Changes
Other Study ID Numbers: SAKK 16/08
First Posted: January 29, 2010    Key Record Dates
Last Update Posted: July 25, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Swiss Group for Clinical Cancer Research:
stage IIIB non-small cell lung cancer
adenocarcinoma of the lung
adenosquamous cell lung cancer
large cell lung cancer
squamous cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action