Icotinib in Combination With Chemotherapy Versus Chemotherapy Alone in Patients Progressed After Icotinib Treatment
This study is currently recruiting participants.
Verified April 2013 by Zhejiang Beta Pharma Inc.
Sponsor:
Zhejiang Beta Pharma Inc.
Information provided by (Responsible Party):
Zhejiang Beta Pharma Inc.
ClinicalTrials.gov Identifier:
NCT01707329
First received: October 11, 2012
Last updated: April 26, 2013
Last verified: April 2013
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Purpose
This phase II randomised, double blind, placebo controlled, multicentre trial is designed to assess the efficacy and safety of continuous icotinib plus chemotherapy versus chemotherapy alone in patients who have progressed after benefiting from previous second or third-line icotinib treatment (more than 6 months) in locally advanced or metastatic non-small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-small Cell Lung Cancer |
Drug: Chemotherapy Drug: Icotinib+chemotherapy |
Phase 2 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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 |
Resource links provided by NLM:
Further study details as provided by Zhejiang Beta Pharma Inc.:
Primary Outcome Measures:
- Progression Free Survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 180 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Chemotherapy
Docetaxel 60-75mg/m2, 4 cycles; or pemetrexed 500mg/m2, 4 cycles.
|
Drug: Chemotherapy
Docetaxel 60-75mg/m2, 4 cycles; or pemetrexed 500mg/m2, 4 cycles.
Other Names:
|
|
Icotinib+Chemotherapy
Icotinib: 125 mg is administered orally three times per day. Chemotherapy: docetaxel 75mg/m2, 4 cycles; or pemetrexed 500mg/m2, 4 cycles.
|
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:
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Study population in this trial aims to patients who have benefited from previous second or third-line icotinib treatment (more than 6 months) in locally advanced or metastatic non-small cell lung cancer and have progressed.
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01707329
Contacts
| Contact: Zhang Yi Ping, MD | 0086-13750881678 | zyp@medmail.com.cn |
Locations
| China, Hunan | |
| Hunan Province Tumor Hospital | Active, not recruiting |
| Changsha, Hunan, China, 410205 | |
| China, Zhejiang | |
| 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 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 | |
| Sir Run Run Shaw Hospital | Active, not recruiting |
| Hangzhou, Zhejiang, China, 310000 | |
| The First Affiliated Hospital of Wenzhou Medical College | Active, not recruiting |
| Wenzhou, Zhejiang, China, 325000 | |
Sponsors and Collaborators
Zhejiang Beta Pharma Inc.
Investigators
| Principal Investigator: | Zhang Yi Ping, M.D. | Zhejiang Cancer Hospital |
More Information
No publications provided
| Responsible Party: | Zhejiang Beta Pharma Inc. |
| ClinicalTrials.gov Identifier: | NCT01707329 History of Changes |
| Other Study ID Numbers: | BD-IC-IV44 |
| Study First Received: | October 11, 2012 |
| Last Updated: | April 26, 2013 |
| Health Authority: | China: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 19, 2013