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The primary purposes of this study are to assess the safety and efficacy of using high doses of the drug Icotinib (Conmana) as a way to treat patients with non-small cell lung cancer that achieve stable disease after 8 weeks routine therapy.
This is a multi-center phase II randomized controlled study to assess the safety and efficacy of using high doses of the drug Icotinib (Conmana) as a way to treat patients with non-small cell lung cancer that achieve stable disease after 8 weeks routine therapy by PFS, as well as OS and DCR. The adverse events and adverse reaction are evaluated as well.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Icotinib of Routine Dose | Active Comparator | Oral Drug icotinib 125 mg three times per day |
|
| Icotinib of High Dose | Experimental | Oral Drug icotinib 250 mg three times per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Icotinib of routine dose | Drug | Icotinib of routine dose: 125 mg is administered orally three times per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 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. | 15 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhang Yi Ping, M.D. | Contact | 0086-13750881678 | zyp@medmail.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zhang Yi Ping, M.D. | Zhejiang Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Hospital for Chest Tumors & Tuberculosis Diseases | Recruiting | Fuzhou | Fujian | 350000 | China |
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| Icotinib of high dose | Drug | Icotinib: 250 mg is administered orally three times per day. |
|
|
| Transformation rate from stable disease to complete response or partial response |
Number of participants with an stable disease previously achieve complete response or partial response after dose escalation. Either complete response (CR) or partial response (PR) will be evaluated by RECIST, confirmed at least 28 days following the date of the initial response. |
| 6 weeks |
| Incidence rate of adverse events | Number of patients with a adverse event, identified according to the Common Toxicity Criteria (CTC) in evaluable-for-safety population, which included all patients who received at least 1 dose of study medication. | 40 months |
| Fujian Provincal Hospital | Recruiting | Fuzhou | Fujian | 350001 | China |
|
| Fujian Provincal Cancer Hospital | Recruiting | Fuzhou | Fujian | 350014 | China |
|
| The second hospital of Xiamen City | Recruiting | Xiamen | Fujian | 361024 | China |
|
| Hunan Provincal Cancer Hospital | Recruiting | Changsha | Hunan | 410006 | China |
|
| The Second People's Hospital of Sichuan | Recruiting | Chengdu | Sichuan | 610041 | China |
|
| Sir Run Run Shaw Hospital | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| The First Affiliated Hospital of Medical School of Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310000 | China |
|
| The Second Affiliated Hospital of Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310000 | China |
|
| Zhejiang Traditional Chinese Medical Hospital | Active, not recruiting | Hangzhou | Zhejiang | 310006 | China |
| Zhejiang Hospital | Active, not recruiting | Hangzhou | Zhejiang | 310007 | China |
| Zhejiang Provincial People's Hospital | Recruiting | Hangzhou | Zhejiang | 310014 | China |
|
| Yinzhou People's Hospital | Recruiting | Ningbo | Zhejiang | 315040 | China |
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| Ningbo Medical Treatment Center Lihuili Hospital | Recruiting | Ningbo | Zhejiang | 315046 | China |
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| Taizhou Hospital of Zhejiang Province | Recruiting | Taizhou | Zhejiang | 317000 | China |
|
| The First Affiliated Hospital of Wenzhou Medical College | Recruiting | Wenzhou | Zhejiang | 325000 | China |
|
| ID | Term |
|---|---|
| C531470 | icotinib |
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