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A Placebo-Controlled, Multicentre, Randomised, Parallel Group, Trial to Assess the Efficacy, Safety and Tolerability of Gefitinib (Iressa® 250mg) as Maintenance Therapy in Locally Advanced or Metastatic (StageIIIB/IV) Non Small Cell Lung Cancer (NSCLC) Chinese Patients Who HaveNot Experienced Disease Progression or Unacceptable Toxicity During Front Line Standard Platinum-Based Chemotherapy


Phase 4
18 Years
N/A
Not Enrolling
Both
Non-small Cell Lung Cancer (NSCLC)

Thank you

Trial Information

A Placebo-Controlled, Multicentre, Randomised, Parallel Group, Trial to Assess the Efficacy, Safety and Tolerability of Gefitinib (Iressa® 250mg) as Maintenance Therapy in Locally Advanced or Metastatic (StageIIIB/IV) Non Small Cell Lung Cancer (NSCLC) Chinese Patients Who HaveNot Experienced Disease Progression or Unacceptable Toxicity During Front Line Standard Platinum-Based Chemotherapy


Inclusion Criteria:



- Histologically or cytologically confirmed locally advanced or metastatic
(stage=IIIB/IV) non-small cell lung cancer (NSCLC) before the front line
chemotherapy. Note: sputum cytology alone is not acceptable

- Patients have completed 4 cycles of first line platinum contained doublet
chemotherapy without progression or intolerable toxicity.

- Patients with PR or SD on study entry need to have one or more measurable lesions
according to RECIST criteria.

- The study treatment should be started at least 3 weeks (21 days) but no more than 6
weeks (42 days) since last dose of chemotherapy, and within 4 weeks (28 days) since
last tumour assessment.

Exclusion Criteria:

- Prior exposure to monoclonal antibodies or small molecule inhibitors against EGFR
receptors. (e.g. gefitinib, erlotinib, C225)

- Patients with previously diagnosed and treated CNS metastases or spinal cord
compression may be considered if they are clinically stable and have been
discontinued from steroid therapy for at least 4 weeks prior to first dose of study
medication.

- Any evidence of clinically active interstitial lung disease (patients with chronic,
stable, radiographic changes who are asymptomatic need not be excluded)

- Known biomarker status of one or more of the following: Tumour EGFR gene copy number,
tumour EGFR gene mutation status, tumour EGFR protein expression.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival (PFS)

Outcome Description:

PFS will be calculated from the tumour measurements collected at each tumour assessment per the RECIST criteria and/or the date of patient death. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.

Outcome Time Frame:

From date of randomization until the date of first documented progression or date of death from any cause, whichever came first.The primary analysis of PFS will be performed when at least 265 events have occurred, which is expected to occur approximately.

Safety Issue:

No

Authority:

China: Food and Drug Administration

Study ID:

D7913L00071

NCT ID:

NCT00770588

Start Date:

September 2008

Completion Date:

February 2011

Related Keywords:

  • Non-Small Cell Lung Cancer (NSCLC)
  • non-small cell lung cancer (NSCLC)
  • Gefitinib
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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