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

• ClinicalTrials.gov Identifier: NCT01707329
• Recruitment Status: Unknown
• First Posted: October 16, 2012
• Last Update Posted: September 9, 2015
• Sponsor: Betta Pharmaceuticals Co., Ltd.
• Information provided by (Responsible Party): Betta Pharmaceuticals Co., Ltd.

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Non-small Cell Lung Cancer	Drug: Chemotherapy; Drug: Icotinib+chemotherapy	Phase 2

Study Design

• 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

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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
• Other Study ID Numbers: BD-IC-IV44
• First Posted: October 16, 2012
• Last Update Posted: September 9, 2015
• Last Verified: September 2015

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