Icotinib in Combination With Chemotherapy Versus Chemotherapy Alone in Patients Progressed After Icotinib Treatment
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ClinicalTrials.gov Identifier: NCT01707329 |
Recruitment Status : Unknown
Verified September 2015 by Betta Pharmaceuticals Co., Ltd..
Recruitment status was: Recruiting
First Posted : October 16, 2012
Last Update Posted : September 9, 2015
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Condition or disease | Intervention/treatment | Phase |
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Non-small Cell Lung Cancer | Drug: Chemotherapy Drug: Icotinib+chemotherapy | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 180 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Randomised, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of Icotinib in Combination With Chemotherapy Versus Chemotherapy Alone in Patients Who Have Progressed After Icotinib Treatment in NSCLC |
Study Start Date : | September 2012 |
Estimated Primary Completion Date : | July 2016 |
Estimated Study Completion Date : | December 2016 |

Arm | Intervention/treatment |
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Active Comparator: Chemotherapy
Docetaxel 60-75mg/m2, 4 cycles; or pemetrexed 500mg/m2, 4 cycles.
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Drug: Chemotherapy
Docetaxel 60-75mg/m2, 4 cycles; or pemetrexed 500mg/m2, 4 cycles.
Other Names:
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Experimental: Icotinib+Chemotherapy
Icotinib: 125 mg is administered orally three times per day. Chemotherapy: docetaxel 75mg/m2, 4 cycles; or pemetrexed 500mg/m2, 4 cycles.
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Drug: Icotinib+chemotherapy
Icotinib: 125 mg is administered orally three times per day. Chemotherapy: docetaxel 75mg/m2, 4 cycles; or pemetrexed 500mg/m2, 4 cycles.
Other Names:
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- Progression Free Survival [ Time Frame: 6 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.
- Overall survival [ Time Frame: 12 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.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically or cytologically confirmed stage IIIB/IV lung cancer(exclude patients confirmed by sputum cytology)
- No previous targeted treatment such as gefitinib, erlotinib.
- With a measurable disease(longest diameters >=10mm with Spiral computed tomography (CT)and >=20mm with conventional CT) according to RECIST Criteria
- WHO performance status(PS)<= 2
- N>=1.5×109/L, Plt>=1.0×109/L,Hb>=10g/dL;AST&ALT should <3ULN(without liver metastasis) or <5ULN(with liver metastasis).TBIL<=1.5ULN.
- Signed and dated informed consent before the start of specific protocol procedures.
Exclusion Criteria:
- Allergic to icotinib
- Patients with metastatic brain tumors with symptoms.
- Experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or small molecular compounds therapy such as gefitinib, erlotinib or Cetuximab.
- Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01707329
Contact: Zhang Yi Ping, MD | 0086-13750881678 | zyp@medmail.com.cn |
China, Hunan | |
Hunan Province Tumor Hospital | Active, not recruiting |
Changsha, Hunan, China, 410205 | |
China, Zhejiang | |
Sir Run Run Shaw Hospital | Active, not recruiting |
Hangzhou, Zhejiang, China, 310000 | |
The First Affiliated Hospital of Medical School of Zhejiang University | Active, not recruiting |
Hangzhou, Zhejiang, China, 310000 | |
The Second Affiliated Hospital of Zhejiang University School of Medicine | Active, not recruiting |
Hangzhou, Zhejiang, China, 310000 | |
Zhejiang Cancer Hospital | Recruiting |
Hangzhou, Zhejiang, China, 310000 | |
Contact: Zhang Yi Ping, M.D. 0086-13750881678 zyp@medmail.com.cn | |
Principal Investigator: Zhang Yi Ping, M.D. | |
The First Affiliated Hospital of Wenzhou Medical College | Active, not recruiting |
Wenzhou, Zhejiang, China, 325000 |
Principal Investigator: | Zhang Yi Ping, M.D. | Zhejiang Cancer Hospital |
Responsible Party: | Betta Pharmaceuticals Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT01707329 |
Other Study ID Numbers: |
BD-IC-IV44 |
First Posted: | October 16, 2012 Key Record Dates |
Last Update Posted: | September 9, 2015 |
Last Verified: | September 2015 |
Carcinoma, Non-Small-Cell Lung Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |