Nimotuzumab Combined With Chemoradiotherapy for Unresectable Locally Advanced Squamous Cell Lung Cancer

Study Overview
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Brief Summary
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This Phase II randomized study is to determine the efficacy and toxicity of Nimotuzumab in combined with chemoradiotherapy for unresectable,local advanced squamous cell lung cancer.

Detailed Description
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This Phase II randomized study is to determine the efficacy and toxicity of Nimotuzumab combined with chemoradiotherapy for unresectable,locally advanced squamous cell lung cancer. All patients were planned to receive radical dose of chest radiation and concurrent chemotherapy of weekly docetaxel and cisplatin, each of 1 day's duration. Nimotuzumab group was treated with weekly nimotuzumab (200mg, IV) combined with chemoradiotherapy, while control group was treated with chemoradiotherapy.

Official Title
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A Prospective Randomized Phase Ⅱ Study of Nimotuzumab Combined With Chemoradiotherapy for Unresectable, Locally Advanced Squamous Cell Lung Cancer

Conditions
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Non-small-cell Lung Cancer

Intervention / Treatment
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* Drug: Nimotuzumab
* Drug: docetaxel and cisplatin
* Radiation: daily RT to the chest


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically confirmed squamous cell lung cancer patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria unresectable phase IIIA(N2) and IIIB lung cancer confirmed by CT or MRI ECOG performance status 0-1 Previously treated with chemotherapy or treatment-naive no previous chest radiotherapy, immunotherapy or biotherapy. hemoglobin≥10 mg/dL, platelet≥100000/μL,absolute neutrophil count ≥1500/μL serum creatinine ≤1.25 times the upper normal limit(UNL), or creatinine clearance≥60 ml/min bilirubin ≤1.5 times UNL, AST（SGOT）≤2.5 times UNL ,ALT（SGPT）≤2.5 times UNL,alkaline phosphatase ≤5 times UNL FEV1 >0.8 L CB6 within normal limits patients and their family signed the informed consents Exclusion Criteria: adenosquamous carcinoma previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ contraindication for chemotherapy women in pregnancy, lactation period, or no pregnancy test 14 days before the first dose women who has the probability of pregnancy without contraception tendency of hemorrhage in other clinical trials within 30 days addicted in drugs or alcohol, AIDS patients uncontrollable seizure or psychotic patients without self-control ability severe allergy or idiosyncrasy not suitable for this study judged by researchers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Nimotuzumab<br>Daily RT to the chest, concurrent chemotherapy of weekly docetaxel and cisplatin, and concurrent weekly Nimotuzumab. | Drug: Nimotuzumab<br>* Patients received weekly nimotuzumab (200mg, IV) concurrent with chemoradiotherapy.<br>Drug: docetaxel and cisplatin<br>* Patients received weekly docetaxel and cisplatin, each of 1 day's duration,concurrent with chest radiotherapy<br>Radiation: daily RT to the chest<br>* Patients received daily RT to the chest<br>|
| Active Comparator: Control<br>Daily RT to the chest, concurrent chemotherapy of weekly docetaxel and cisplatin. | Drug: docetaxel and cisplatin<br>* Patients received weekly docetaxel and cisplatin, each of 1 day's duration,concurrent with chest radiotherapy<br>Radiation: daily RT to the chest<br>* Patients received daily RT to the chest<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate |  | 3 years | 
| progression-free survival |  | 3 years | 
| rate of grade 3-4 radiation esophagitis | rate of grade 3-4 radiation esophagitis as assessed by CTCAE v4.0 | 1 years | 
| rate of grade 3-4 radiation pneumonitis | rate of grade 3-4 radiation pneumonitis as assessed by CTCAE v4.0 | 1 year | 
| Failure patterns | rates of local-regional recurrence, distant metastasis and brain metastasis | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nimotuzumab, Chemoradiotherapy,Squamous Cell Lung Cancer