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A Phase III Randomised, Double Blind, Placebo Controlled, Parallel, Multicentre Study to Assess the Efficacy and Safety of Continuing IRESSA 250 mg in Addition to Chemotherapy Versus Chemotherapy Alone in Patients Who Have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) and Have Progressed on First Line IRESSA


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer

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Trial Information

A Phase III Randomised, Double Blind, Placebo Controlled, Parallel, Multicentre Study to Assess the Efficacy and Safety of Continuing IRESSA 250 mg in Addition to Chemotherapy Versus Chemotherapy Alone in Patients Who Have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) and Have Progressed on First Line IRESSA


A Phase III Randomised, Double blind, Placebo controlled, Parallel, Multicentre Study to
Assess the Efficacy and Safety of continuing IRESSA 250 mg in addition to Chemotherapy
versus Chemotherapy alone in Patients who have Epidermal Growth Factor Receptor (EGFR)
Mutation Positive Locally advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) and have
progressed on First Line IRESSA.


Inclusion Criteria:



- Male or female patients aged 18 years or older (For Japan only- male or female
patients aged 20 years or older)

- Cytological or histological confirmation of NSCLC other than predominantly squamous
cell histology with an activating EGFR TK mutation as determined locally

- Patients with documented 'acquired resistance' on first line gefitinib

- Patients suitable to start cisplatin based pemetrexed combination chemotherapy.

- Provision of informed consent prior to any study specific procedures.

Exclusion Criteria:

- Prior chemotherapy or other systemic anti-cancer treatment (excluding gefitinib).
Palliative radiotherapy must be completed at least 4 weeks before start of study
treatment with no persistent radiation toxicity).

- Past medical history of interstitial lung disease, drug-induced interstitial disease,
radiation pneumonitis which required steroid treatment or any evidence of clinically
active interstitial lung disease

- Other co-existing malignancies or malignancies diagnosed within the last 5 years,
with the exception of basal cell carcinoma or cervical cancer in situ or completely
resected intramucosal gastric cancer

- Any evidence of severe of uncontrolled systemic disease Treatment with an
investigational drug within 4 weeks before randomization

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression Free Survival (PFS) in patients with Gefitinib + Pemetrexed & Cisplatin as compared to patients with Pemetrexed & Cisplatin alone.

Outcome Time Frame:

An expected average of 48 weeks after last subject enrolled into our study

Safety Issue:

No

Principal Investigator

Haiyi Jiang, M.D. MSc

Investigator Role:

Study Director

Investigator Affiliation:

Zhangjiang Hi-tech Park, 3F, Room 3102, 199 Liangjing Road, Pudong Shanghai, postal code:201203

Authority:

China: Food and Drug Administration

Study ID:

D791LC00001

NCT ID:

NCT01544179

Start Date:

March 2012

Completion Date:

January 2016

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Non Small Cell Lung Cancer
  • Gefitinib
  • Pemetrexed
  • Treatment Beyond Progression
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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