Chemoradiotherapy in Stage III Non-small Cell Lung Cancer (NSCLC)

Study Overview
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Brief Summary
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Radiochemotherapy is a standard for the treatment of unresectable stage III non-small cell lung cancer. The investigators goal is to study the efficacy and the toxicity for a promising association of new agents (cetuximab and pemetrexed) with concurrent radiotherapy.

Official Title
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Phase II Study of Pemetrexed + Cetuximab + Cisplatin With Concurrent Chemoradiotherapy in Stage III Non-small Cell Lung Cancer (NSCLC)

Conditions
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Stage III Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Chemotherapy
* Drug: ERBITUX
* Radiation: Radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: non-squamous stage III non-small cell lung cancer measurable disease (RECIST 1.1) ECOG performance status 0-1 normal organ and marrow function Exclusion Criteria: prior chest radiation therapy history of any cancer other than NSCLC (except non-melanoma skin cancer or carcinoma in situ of the cervix) within the last five years. Prior therapy with known specific inhibitors of the EGFR. history of severe allergic reaction to prior therapy with monoclonal antibodies

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Chemoradiotherapy | Drug: Chemotherapy<br>* Pemetrexed 500 mg/m², D1 (D1=D22, 4 cycles) Cisplatin 75 mg/m², D1 (D1=D22, 4 cycles)<br>Drug: ERBITUX<br>* The initial dose of cetuximab (ERBITUX) is 400 mg/m² intravenously administered over 120 minutes, followed by 11 weekly infusions at 250 mg/m² IV over 60 minutes<br>Radiation: Radiotherapy<br>* 66 Gy (2 Gy by fraction, 5 fractions by week)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-Control Rate | percentage of patients with disease control (complete response + partial response + stable disease) according to RECIST 1.1 criteria Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for Progressive Disease (at least a 20% increase in the sum of diameters of target lesions). | 16 weeks after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 18-month Overall Survival Rate | Percentage of patient alive 18 months after registration | 18 months | 
| Progression Free Survival | Progression-free survival is defined as time between date of inclusion and progression or all-cause death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | 52.3 months (median duration of follow-up) |