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Status unknownNCT02027090Updated May 22, 2015

High Dose Versus Routine Dose Icotinib in Advanced Non-small Cell Lung Cancer Patients With Stable Disease

A Phase 2 interventional study of Routine dose icotinib and Higher dose icotinib in Non-small Cell Lung Cancer, sponsored by Betta Pharmaceuticals Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-05-22.

Sponsored by Betta Pharmaceuticals Co., Ltd. · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2015), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Non-small Cell Lung Cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 64 is close to the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Betta Pharmaceuticals Co., Ltd. is the lead sponsor of 79 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
64 participants (estimated)

Study arms

  • Experimental
    Higher dose icotinib

    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

  • Active comparator
    Routine dose icotinib

    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

  • DrugRoutine dose icotinib

    Icotinib is administered 125 mg three times daily.

    Also known as: Commana

  • DrugHigher dose icotinib

    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

06

What researchers measure

Primary outcomes

  1. Progression-free survival

    Time frame: 5 months

Secondary outcomes

  1. Overall survival

    Time frame: 18 months

  2. Response rate assessed using the RECIST criteria

    Time frame: 2 months

  3. The number of patients who suffered adverse events

    Adverse events are assessed by Common Terminology Criteria for Adverse Events v4.0

    Time frame: 30 months

07

Study locations

1 site
  • Shanghai Chest Hospital Affiliated to Shanghai Jiaotong University
    Shanghai, Shanghai 200030, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02027090
Lead sponsor
Betta Pharmaceuticals Co., Ltd.
Responsible party
Sponsor
First posted
Jan 3, 2014
Start date
Jan 2014
Primary completion
Jun 2016 (estimated)
Completion
Dec 2016 (estimated)
Last update
May 22, 2015

Study contacts

Shun Lu, MD
principal investigator · Shanghai Chest Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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