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

NCT02194556 | Unknown Phase 4 DMC

• 1 other identifier: BD-IC-IV69
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

EGFR Positive Non-small Cell Lung Cancer; Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Overall survival

  24 months

• Objective response rate

  24 months

• Adverse events

  24 months

• Disease control rate (DCR)

  24 months

Study Arms (2)

Sequential and maintenance icotinib

EXPERIMENTAL

Patients are administered with sequential and maintenance icotinib plus chemotherapy. Gemcitabine 1000mg/m2 iv d1 and d8, cisplatin 75mg/m2 iv d1, 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 icotinib as maintenance treatment until disease progression or intolerable toxicity.

Drug: Sequential and maintenance icotinib

Maintenance icotinib

ACTIVE COMPARATOR

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 icotinib (125 mg three times per day) as maintenance treatment until disease progression or intolerable toxicity.

Drug: Maintenance icotinib

Interventions

Sequential and maintenance icotinib DRUG

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.

Also known as: Gemzar, DDP, Comana, BPI-2009

Sequential and maintenance icotinib

Maintenance icotinib DRUG

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.

Also known as: Gemzar, DDP, Comana, BPI-2009

Maintenance icotinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Betta Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

Location

MeSH Terms

Conditions

Adenocarcinoma

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Xiaohua Hu, MD

  First Affiliated Hospital of Guangxi Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2014
• First Posted: July 18, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 18, 2014

Record last verified: 2014-07

Locations

CN (1)