Icotinib in Combination With Chemotherapy Versus Chemotherapy Alone in Patients Progressed After Icotinib Treatment

This study is currently recruiting participants. (see Contacts and Locations)

Verified September 2015 by Betta Pharmaceuticals Co.,Ltd.

Sponsor:

Information provided by (Responsible Party):

Betta Pharmaceuticals Co.,Ltd.

ClinicalTrials.gov Identifier:

NCT01707329

First received: October 11, 2012

Last updated: September 5, 2015

Last verified: September 2015

History of Changes

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:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: lung cancer

Drug Information available for: Docetaxel Pemetrexed Pemetrexed disodium

U.S. FDA Resources

Further study details as provided by Betta Pharmaceuticals Co.,Ltd.:

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:	December 2016
Estimated Primary Completion Date:	July 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 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: Taxotere ALIMTA
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.	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: Icotinib Comana BPI-2009

Eligibility


Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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

Sponsors and Collaborators

Betta Pharmaceuticals Co.,Ltd.

Investigators


Principal Investigator:	Zhang Yi Ping, M.D.	Zhejiang Cancer Hospital

More Information


Responsible Party:	Betta Pharmaceuticals Co.,Ltd.
ClinicalTrials.gov Identifier:	NCT01707329 History of Changes
Other Study ID Numbers:	BD-IC-IV44
Study First Received:	October 11, 2012
Last Updated:	September 5, 2015
Health Authority:	China: Food and Drug Administration

Additional relevant MeSH terms:


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	Docetaxel Pemetrexed Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 27, 2016

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