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An Open , Single-Center, Single Arm Trial to Evaluate the Efficacy and Safety of Dose Escalation of Icotinib in Advanced NSCLC Patients After Routine Icotinib Therapy


Phase 4
18 Years
75 Years
Open (Enrolling)
Both
Non-small Cell Lung Cancer

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Trial Information

An Open , Single-Center, Single Arm Trial to Evaluate the Efficacy and Safety of Dose Escalation of Icotinib in Advanced NSCLC Patients After Routine Icotinib Therapy


Lung cancer is a major cause of morbidity and mortality, which is the rapidest increased
type of cancer in China with over 5 times incidence rate increase during the past 30 years.
Tyrosine kinase inhibitors (TKIs) of the epidermal growth factor receptor (EGFR) have been
widely used for the treatment of patients with non-small cell lung cancer(NSCLC). Icotinib
is a novel EGFR-TKI developed by a group of Chinese scientists and clinician. Icotinib
appears to be non-inferior to Gefitinib in terms of efficacy, better in terms of safety, and
larger of therapeutic window in phase I-III trials. In this study, an open , single-center,
single arm phase IV trial was designed to evaluate the safety and efficacy of dose
escalation of icotinib in the treatment of advanced NSCLC patients after failure with
routine dose. PFS (progress free survival) is the primary end-point with OS (overall
survival), ORR (objective response), TTP (time to progress), HRQOL and safety as the
secondary end-point.


Inclusion Criteria:



1. Confirmed NSCLC with Histology or cytology; advanced (IIIb/IV).

2. Must have received 1 or 2 chemotherapy (at least 1 is platin based)before, and prior
chemotherapy must be completed at least 4 weeks before study enrollment.

3. Measurable, evaluable disease outside of a radiation port.

Exclusion Criteria:

1. Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin,
erbitux.

2. Other co-existing malignancies or malignancies diagnosed within the last 5 years with
the exception of basal cell carcinoma or cervical cancer in situ.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival

Outcome Time Frame:

6-12 months

Safety Issue:

No

Principal Investigator

Li Xi qing, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

307 Hospital of People's Liberation Army(PLA)

Authority:

China: Food and Drug Administration

Study ID:

BD-IC-IV01

NCT ID:

NCT01465243

Start Date:

September 2011

Completion Date:

November 2013

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Efficacy
  • Safety
  • EGFR-TKI
  • phase IV
  • NSCLC
  • Dose escalation
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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