NCT02027090

Brief Summary

We hypothesize that higher dose icotinib is related with better efficacy. The primary objective is to compare the progression-free survival of higher dose and routine dose of icotinib in treating pretreated advanced non-small cell lung cancer patients with stable disease after 8-week routine dose icotinib treatment.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for phase_2 nonsmall-cell-lung-cancer

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 3, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 22, 2015

Status Verified

May 1, 2015

Enrollment Period

2.4 years

First QC Date

January 1, 2014

Last Update Submit

May 21, 2015

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    5 months

Secondary Outcomes (3)

  • Overall survival

    18 months

  • Response rate assessed using the RECIST criteria

    2 months

  • The number of patients who suffered adverse events

    30 months

Study Arms (2)

Higher dose icotinib

EXPERIMENTAL

Patients with stable disease after 8-week routine dose icotinib treatment, are randomly assigned to higher dose icotinib group to receive icotinib with a dose of 375 mg three times per day, till progressive disease or unaccepted toxicity.

Drug: Higher dose icotinib

Routine dose icotinib

ACTIVE COMPARATOR

Patients with stable disease after 8-week routine dose icotinib treatment, are administered with icotinib with a dose of 125 mg three times per day, till progressive disease or unaccepted toxicity.

Drug: Routine dose icotinib

Interventions

Routine dose icotinibDRUG

Icotinib is administered 125 mg three times daily.

Also known as: Commana
Routine dose icotinib
Higher dose icotinibDRUG

After 8-week induction of icotinib with a dose of 125 mg three times daily, icotinib is administered 375 mg three times per day.

Also known as: Commana
Higher dose icotinib

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed stage IIIB/IV lung cancer(exclude patients confirmed by sputum cytology);
  • Pretreated with at least 1 platinum-based chemotherapy;
  • 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;
  • Adequate organ functions;
  • Signed and dated informed consent before the start of specific protocol procedures.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Chest Hospital Affiliated to Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

icotinib

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Shun Lu, MD

    Shanghai Chest Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 1, 2014

First Posted

January 3, 2014

Study Start

January 1, 2014

Primary Completion

June 1, 2016

Study Completion

December 1, 2016

Last Updated

May 22, 2015

Record last verified: 2015-05

Locations

CN(1)