Clinical trial · Interventional
Feasibility of Cetuximab Associated With Concomitant Radio-Chemotherapy in Patients With Locally Advanced Non Small Cell Lung Cancer
Feasibility of Cetuximab (ERBITUX®) Associated With Concomitant Radio-chemotherapy in Patients With Locally Advanced Non Small Cell Lung Cancer: a Phase II, Randomised Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small-Cell Lung Carcinoma | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatine, etoposide, cetuximab | Drug | — | UNRESOLVED |
| cisplatin, vinorlebine, cetuximab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cisplatin, vinorelbine
- description
- 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.
- interventionNames
- Drug: cisplatin, vinorlebine, cetuximab
- type
- EXPERIMENTAL
- label
- Cisplatin, etoposide
- description
- 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.
- interventionNames
- Drug: cisplatine, etoposide, cetuximab
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available