Nimotuzumab in Combination With Cisplatin and Docetaxel for Patients With Advanced Non-small Cell Lung Cancer
Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with head and neck cancer. The study assessed the safety, and efficacy of the combination of Nimotuzumab administered concomitantly with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 1 Study of Nimotuzumab in Combination With Cisplatin and Docetaxel for Patients With Advanced Non-small Cell Lung Cancer|
- Safety and toxicity of this new treatment. Both acute and chronic toxicity will be evaluated. [ Time Frame: within study period ] [ Designated as safety issue: Yes ]
- To determine the complete response rate、partial rate、disease response rate、disease control rate in the patients subject to treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Study Completion Date:||August 2015|
|Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Drug: Nimotuzumab and chemotherapy
The chemotherapy treament：docetaxel( 75mg/m2/d,every21days,for4~6cycles) and cisplatin(total dose 75mg/m2 on day 2,3,4,every21days,for4~6cycles).
the nimotuzumab treatment:3 levels (200mg/w,400mg/w,600mg/w,weekly,for12~18 weeks).
Other Name: Nimotuzumab
Altered expression or constitutive activation of the epidermal growth factor receptor (EGFR/HER1/erbB1) commonly occurs in primary NSCLC, and is often a critical factor in progressive growth and resistance to normal mechanisms of cell death. Epidermal growth factor receptor expression in lung cancer has been correlated with tumor aggressiveness. Clinical trials already suggest that EGFR targeted therapy may improve the antitumor activity of chemotherapy for treatment of lung carcinoma. Monoclonal antibodies specific to EGFR can be combined safely and effectively with chemotherapy. Nimotuzumab (hR3) is a humanized monoclonal antibody (mAb) that binds to the EGFR. In preclinical studies the antibody has shown potent antitumor activity. A previous phase II study in children with high grade brain tumors showed activity of Nimotuzumab as a monotherapeutic agent, even in prognostic very unfavourable diffuse, intrinsic pontine glioma. No drug related side effects were reported. Nimotuzumab (hR3) in combination with radiotherapy for treatment of locally advanced squamous cell carcinomas of the head and neck resulted in high rates of antitumor response, and was accompanied by a favourable safety profile.
This is a dose-escalation study of Nimotuzumab. Nimotuzumab in combination with chemotherapy will be administered to the patients with advanced NSCLC. The patients' blood test and liver and renal function tests will be monitored weekly, a physical exam and reassessment of the tumor will be performed and every 6 weeks. When the total result is the CR or PR, the results of the 6th, 12th, 18th and the 22th week should be compared.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00985998
|Cancer Institute & Hospital, Chinese Academy of Medical Sciences|
|Beijing, Beijing, China, 100000|
|Principal Investigator:||Yuankai Shi, Professor||86-10-87788121|