Sequential and Maintenance Icotinib Plus Chemotherapy Versus Icotinib Maintenance After Chemotherapy in Advanced NSCLC

Adenocarcinoma Clinical Trial

Official title:

Sequential and Maintenance Icotinib Plus Chemotherapy Versus Icotinib Maintenance After Chemotherapy in Untreated Advanced Non-small-cell Lung Cancer: a Randomized, Open-label Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02194556
• Other study ID #: BD-IC-IV69
• Status: Active, not recruiting
• Phase: Phase 4
• First received: July 16, 2014
• Last updated: July 17, 2014
• Start date: July 2014
• Est. completion date: July 2017

Study information

• Verified date: July 2014
• Source: Betta Pharmaceuticals Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This randomised, controlled, open-label, prospective trial is designed to assess the efficacy and safety of icotinib maintenance therapy after sequential Icotinib plus chemotherapy versus Icotinib maintenance therapy after chemotherapy in stage IIIB/IV non-small cell lung cancer patients with EGFR mutation.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Stage IV or IIIB advanced non-small cell lung cancer patients

• Positive EGFR Mutation

• Non-progressive disease after first-line gemcitabine/cisplatin therapy

• Measurable lesion according to RECIST 1.1 with at least one measurable lesion

Exclusion Criteria:

• Previous anti-EGFR (epidermal growth factor receptor) monoclonal antibody or small molecular agent such as gefitinib, erlotinib and so on

• Patients with wild-type EGFR

• Evidence of interstitial lung diseases

• Severe hypersensitivity to icotinib or any of the excipients of this product.

• Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma, Non-Small-Cell Lung
• EGFR Positive Non-small Cell Lung Cancer

Intervention

Drug:
• Sequential and maintenance icotinib
Patients are administered with sequential and maintenance icotinib plus chemotherapy. Gemcitabine 1000mg/m2 iv d1 and d8, cisplatin 75mg/m2 iv d1, sequential icotinib 125 mg is administered orally three times per day at d 8-21, every 3 weeks for a cycle. After receiving a maximum of 4-cycle treatment, non-progressive patients continue to receive maintenance icotinib until disease progression or intolerable toxicity.
• Maintenance icotinib
Gemcitabine 1000mg/m2 iv d1 and d8, cisplatin 75mg/m2 iv d1. After receiving a maximum of 4-cycle treatment, non-progressive patients continue to receive maintenance icotinib (125 mg three times per day) until disease progression or intolerable toxicity.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Guangxi Medical University	NanNing	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
Betta Pharmaceuticals Co.,Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	15 months	No
Secondary	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.	24 months	No
Secondary	Objective response rate	Number of subjects with confirmed objective response according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.	24 months	No
Secondary	Adverse events	The number of patients who suffered adverse events, which is graded by NCI CTCAE version 4.0.	24 months	Yes
Secondary	Disease control rate (DCR)	Disease control rate including complete response (CR) o,partial response (PR) , stable disease (SD)	24 months	No