Feasibility of Cetuximab Associated With Concomitant Radio-Chemotherapy in Patients With Locally Advanced Non Small Cell Lung Cancer

Study Overview
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Brief Summary
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Phase II, randomised, controlled, non comparative study with 2 parallel groups: Arm A: patients will receive induction chemotherapy (cisplatin and docetaxel) followed by a concomitant radio-chemotherapy including 2 cycles of cisplatin and vinorelbine associated with a weekly cetuximab infusion during the radiotherapy. Arm B: patients will receive induction chemotherapy (cisplatin and docetaxel) followed by a concomitant radio-chemothérapy including 2 cycles of cisplatin and etoposide associated with a weekly cetuximab infusion during the radiotherapy.

Official Title
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Feasibility of Cetuximab (ERBITUX®) Associated With Concomitant Radio-chemotherapy in Patients With Locally Advanced Non Small Cell Lung Cancer: a Phase II, Randomised Study

Conditions
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Non-Small-Cell Lung Carcinoma

Intervention / Treatment
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* Drug: cisplatin, vinorlebine, cetuximab
* Drug: cisplatine, etoposide, cetuximab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-Small-Cell Lung cancer cytologically or histologically proved Stage III AN2 inoperable or non resectable presence of at least one one dimension measurable target (at least 10 mm with spiral tomodensitometry) Possibility to include all targets in one irradiation field Age of 18 to 70 Patients non previously treated Performance Status 0 or 1 Loss of weight ≤10% in the 3 last months Neutrophil ≥ 1500/mm3 and platelets ≥ 100000/mm3 Creatinine clearance ≥ 60 ml/min total bilirubin ≤ 1,5N and ASAT ALAT ≤ 2,5N Respiratory function normal: VEMS ≥ 40% theorical, DLCO/VA ≥ 50% theorical and PaO2 ≥ 60 mmHg Signed inform consent form Compliance to radiotherapy 66 Gy with dosimetry V20 ≤ 35% and pulmonary mean dose≤20 Gy Exclusion Criteria: Pretreated bronchial carcinoma, excepted endoscopic deobstruction operable bronchial carcinoma small cell lung cancer, composite cancer, neuroendocrine cancer, broncho alveolar cancer superior vena cava syndroms puncturable pleural effusion metastatic lung cancer Stage IIIb cancer with neoplastic pericarditis Previous thoracic irradiation severe cardiac disease in the 12 months before inclusion interstitial lung disease anti-EGFR and anti-VEGF treatments hypersensitivity to murine proteins and allergies to protocol drugs uncontrolled infectious state HIV patient corticoid definitive contraindication péripheric neuropathy grade≥2 neurologic, psychiatric and organic disorder past or concomitant cancer excepted treated skin baso-cellular cancer or in situ cervical cancer, or any cancer only surgically treated for 5 years breastfeeding woman

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cisplatin, vinorelbine<br>patients will receive induction chemotherapy (cisplatin, docetaxel) followed by a concomitant radio-chemothérapy including 2 cycles of cisplatin and vinorelbine associated with a weekly cetuximab infusion during the radiotherapy. | Drug: cisplatin, vinorlebine, cetuximab<br>* patient will receive 2 cycles of cisplatine 80 mg/m² at day 29 and day 50 more vinorelbine 15 mg/m² at day 29, day 36 and day 50 and 57 associated to cetuximab 400 mg/m² at day: 22,29, 36, 43, 50, 57, 64 and 71<br>|
| Experimental: Cisplatin, etoposide<br>patients will receive induction chemotherapy (cisplatin, docetaxel) followed by a concomitant radio-chemothérapy including 2 cycles of cisplatin and etoposide associated with a weekly cetuximab infusion during the radiotherapy. | Drug: cisplatine, etoposide, cetuximab<br>* patient will receive 2 cycles of cisplatine 50 mg/m² at day 29, 36, 57, and 64 + étoposide 50mg/m² during day 29-33, day 57-61associated to cetuximab 400 mg/m² at day: 22,29, 36, 43, 50, 57, 64 and 71<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of patients presenting at least one toxicity grade≥3 (excepted hematological toxicity and nausea-vomiting) |  | End of concomitant treatment (Day 71) |