Sequential and Maintenance Icotinib Plus Chemotherapy Versus Icotinib Maintenance After Chemotherapy in Advanced NSCLC
Study Details
Study Description
Brief Summary
This randomised, controlled, open-label, prospective trial is designed to assess the efficacy and safety of icotinib maintenance therapy after sequential Icotinib plus chemotherapy versus Icotinib maintenance therapy after chemotherapy in stage IIIB/IV non-small cell lung cancer patients with EGFR mutation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sequential and maintenance icotinib Patients are administered with sequential and maintenance icotinib plus chemotherapy. Gemcitabine 1000mg/m2 iv d1 and d8, cisplatin 75mg/m2 iv d1, icotinib 125 mg is administered orally three times per day at d 8-21, every 3 weeks for a cycle. After receiving a maximum of 4-cycle treatment, non-progressive patients continue to receive icotinib as maintenance treatment until disease progression or intolerable toxicity. |
Drug: Sequential and maintenance icotinib
Patients are administered with sequential and maintenance icotinib plus chemotherapy. Gemcitabine 1000mg/m2 iv d1 and d8, cisplatin 75mg/m2 iv d1, sequential icotinib 125 mg is administered orally three times per day at d 8-21, every 3 weeks for a cycle. After receiving a maximum of 4-cycle treatment, non-progressive patients continue to receive maintenance icotinib until disease progression or intolerable toxicity.
Other Names:
|
| Active Comparator: Maintenance icotinib Gemcitabine 1000mg/m2 iv d1 and d8, cisplatin 75mg/m2 iv d1. After receiving a maximum of 4-cycle treatment, non-progressive patients continue to receive icotinib (125 mg three times per day) as maintenance treatment until disease progression or intolerable toxicity. |
Drug: Maintenance icotinib
Gemcitabine 1000mg/m2 iv d1 and d8, cisplatin 75mg/m2 iv d1. After receiving a maximum of 4-cycle treatment, non-progressive patients continue to receive maintenance icotinib (125 mg three times per day) until disease progression or intolerable toxicity.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Progression Free Survival [15 months]
A duration from randomization date to disease progression(as defined by RECIST) or death. If a participant are known to have progressed, the time to progression is defined as the time from the date of randomization to the date of progression. Otherwise, a participant will be censored at the last date they are known not to be progressed.
Secondary Outcome Measures
- Overall survival [24 months]
Overall Survival is assessed via calculation of the time to death due to any cause. If a participant is known to have died, the time to death is defined as the time from the date of randomization to the date of death. Otherwise, a participant will be censored at the last date they are known to be alive.
- Objective response rate [24 months]
Number of subjects with confirmed objective response according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- Adverse events [24 months]
The number of patients who suffered adverse events, which is graded by NCI CTCAE version 4.0.
- Disease control rate (DCR) [24 months]
Disease control rate including complete response (CR) oļ¼partial response (PR) , stable disease (SD)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Stage IV or IIIB advanced non-small cell lung cancer patients
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Positive EGFR Mutation
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Non-progressive disease after first-line gemcitabine/cisplatin therapy
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Measurable lesion according to RECIST 1.1 with at least one measurable lesion
Exclusion Criteria:
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Previous anti-EGFR (epidermal growth factor receptor) monoclonal antibody or small molecular agent such as gefitinib, erlotinib and so on
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Patients with wild-type EGFR
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Evidence of interstitial lung diseases
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Severe hypersensitivity to icotinib or any of the excipients of this product.
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Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | First Affiliated Hospital of Guangxi Medical University | NanNing | Guangxi | China | 530021 |
Sponsors and Collaborators
- Betta Pharmaceuticals Co., Ltd.
Investigators
- Principal Investigator: Xiaohua Hu, MD, First Affiliated Hospital of Guangxi Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BD-IC-IV69