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Preoperative Chemotherapy and Radiotherapy Concomitant to Cetuximab in Non-Small Cell Lung Cancer (NSCLC) Patients With IIIB Disease - A Multicenter Phase II Trial

Phase 2
18 Years
75 Years
Open (Enrolling)
Lung Cancer

Thank you

Trial Information

Preoperative Chemotherapy and Radiotherapy Concomitant to Cetuximab in Non-Small Cell Lung Cancer (NSCLC) Patients With IIIB Disease - A Multicenter Phase II Trial


- 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

After completion of study treatment, patients are followed every 3 months for 2 years and
every 6 months for 3 years.

Inclusion Criteria


- 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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

at 1 year (+/- 1 month)

Safety Issue:


Principal Investigator

Solange Peters, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Centre Hospitalier Universitaire Vaudois


Switzerland: Swissmedic

Study ID:

SAKK 16/08



Start Date:

January 2010

Completion Date:

June 2016

Related Keywords:

  • Lung Cancer
  • stage IIIB non-small cell lung cancer
  • adenocarcinoma of the lung
  • adenosquamous cell lung cancer
  • large cell lung cancer
  • squamous cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms